aztreonam and Pseudomonas Infections studies

Aztreonam: A monocyclic beta-lactam antibiotic originally isolated from Chromobacterium violaceum. It is resistant to beta-lactamases and is used in gram-negative infections, especially of the meninges, bladder, and kidneys. It may cause a superinfection with gram-positive organisms.
aztreonam : A synthetic monocyclic beta-lactam antibiotic (monobactam), used primarily to treat infections caused by Gram-negative bacteria. It inhibits mucopeptide synthesis in the bacterial cell wall, thereby blocking peptidoglycan crosslinking.

Research Excerpts

Excerpt	Relevance	Reference
"Concomitant use of oral azithromycin and inhaled tobramycin occurs in approximately half of US cystic fibrosis (CF) patients."	9.24	Impact of azithromycin on the clinical and antimicrobial effectiveness of tobramycin in the treatment of cystic fibrosis. ( Bratcher, PE; Caceres, SM; Chmiel, JF; Happoldt, CL; Malcolm, KC; Nichols, DP; Nick, JA; Saavedra, MT; Saiman, L; Taylor-Cousar, JL, 2017)
"To compare overall costs of treatment of chronic inhaled tobramycin and aztreonam lysine in patient with cystic fibrosis who have chronic Pseudomonas infection, taking differences in outcomes into account."	9.20	Inhaled aztreonam lysine versus inhaled tobramycin in cystic fibrosis. An economic evaluation. ( Daines, CL; Farquharson, R; Higuchi, K; Schechter, MS; Trueman, D, 2015)
"Recent studies of inhaled tobramycin in subjects with cystic fibrosis (CF) find less clinical improvement than previously observed."	9.19	Azithromycin may antagonize inhaled tobramycin when targeting Pseudomonas aeruginosa in cystic fibrosis. ( Chmiel, JF; Forssén, AV; Kim, SH; Moskowitz, SM; Nichols, DP; Nick, JA; Saavedra, MT; Saiman, L; Taylor-Cousar, JL, 2014)
"Open-label, parallel-group, international trial comparing aztreonam for inhalation solution (AZLI) and tobramycin nebulizer solution (TNS) for cystic fibrosis patients with airway Pseudomonas aeruginosa."	9.17	Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: a comparative efficacy trial. ( Assael, BM; Bilton, D; Bresnik, M; Chiron, R; Fayon, M; Fischer, R; Knoop, C; LaRosa, M; Lewis, SA; McElvaney, N; Montgomery, AB; Oermann, CM; Pressler, T, 2013)
"Previous aztreonam for inhalation solution (AZLI) studies included patients with cystic fibrosis, Pseudomonas aeruginosa (PA) airway infection, and forced expiratory volume in 1s (FEV(1)) 25% to 75% predicted."	9.15	Aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis, mild lung impairment, and P. aeruginosa. ( Geller, DE; Gibson, RL; Lewis, S; Montgomery, AB; Nakamura, C; Quittner, AL; Wainwright, CE; Wooldridge, JL, 2011)
"We assessed the short-term efficacy and safety of aztreonam lysine for inhalation (AZLI [an aerosolized monobactam antibiotic]) in patients with cystic fibrosis (CF) and Pseudomonas aeruginosa (PA) airway infection."	9.14	Efficacy and safety of inhaled aztreonam lysine for airway pseudomonas in cystic fibrosis. ( Cooper, PJ; Gibson, RL; McCoy, KS; Montgomery, AB; Oermann, CM; Quittner, AL; Retsch-Bogart, GZ, 2009)
"The effectiveness and safety of aztreonam lysine for inhalation (AZLI) in patients with cystic fibrosis (CF) on maintenance treatment for Pseudomonas aeruginosa (PA) airway infection was evaluated in this randomized, double-blind, placebo-controlled study."	9.13	Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. ( Gibson, RL; McCoy, KS; Montgomery, AB; Oermann, CM; Quittner, AL; Retsch-Bogart, GZ, 2008)
"The efficacy of aztreonam was compared to that of standard therapy consisting of tobramycin and azlocillin in the treatment of acute pulmonary exacerbations of cystic fibrosis in a randomized, open trial."	9.06	Controlled trial of aztreonam vs. tobramycin and azlocillin for acute pulmonary exacerbations of cystic fibrosis. ( Black, PG; Bosso, JA, 1988)
"In order to determine the optimal antipseudomonal therapy in patients with cystic fibrosis aztreonam plus amikacin was compared to ceftazidime plus amikacin, and these two-week hospital regimens were followed by oral ciprofloxacin given for four weeks."	9.06	Antipseudomonal therapy in cystic fibrosis: aztreonam and amikacin versus ceftazidime and amikacin administered intravenously followed by oral ciprofloxacin. ( Buehlmann, U; Guenin, K; Kraemer, R; Schaad, UB; Wedgwood-Krucko, J, 1989)
"Preclinical and clinical studies were performed to evaluate usefulness and safety of aztreonam (AZT) in the treatment of acute otitis media, acute exacerbation of chronic otitis media and chronic otitis media and the following results were obtained."	9.06	[Efficacy evaluation of aztreonam for suppurative otitis media]. ( Baba, K; Baba, S; Furuuchi, C; Kawai, T; Kinoshita, H; Maruo, T; Mori, Y; Nagae, D; Suzuki, K; Tanigaito, Y, 1986)
"An aerosol form of aztreonam lysinate has recently been developed as a treatment for cystic fibrosis patients suffering from chronic Pseudomonas aeruginosa lung colonization."	8.87	Aztreonam inhalation solution for suppressive treatment of chronic Pseudomonas aeruginosa lung infection in cystic fibrosis. ( Assael, BM, 2011)
"Studies are required that evaluate real-world outcomes of inhaled aztreonam lysine in patients with cystic fibrosis (CF)."	7.85	A treatment evaluator tool to monitor the real-world effectiveness of inhaled aztreonam lysine in cystic fibrosis. ( Bilton, D; Downey, DG; Eustace, JA; Gunaratnam, C; Haworth, CS; Jones, AM; Ketchell, RI; McKone, EF; Peckham, DG; Plant, BJ, 2017)
"Aztreonam for inhalation solution (AZLI) was recently approved by the FDA for treating cystic fibrosis (CF) patients infected with Pseudomonas aeruginosa."	7.78	In vitro evaluation of tobramycin and aztreonam versus Pseudomonas aeruginosa biofilms on cystic fibrosis-derived human airway epithelial cells. ( Griffin, EF; Moreau-Marquis, S; O'Toole, GA; Schwartzman, JD; Stanton, BA; Yu, Q, 2012)
"To report the successful desensitization of a highly allergic patient with cystic fibrosis (CF) to inhaled aztreonam lysine using the novel approach of intravenous desensitization followed by full-dose inhaled therapy without any adverse reactions."	7.78	Desensitization to inhaled aztreonam lysine in an allergic patient with cystic fibrosis using a novel approach. ( Abdulhamid, I; Ditouras, J; Guglani, L; Montejo, J, 2012)
" aeruginosa colonised cystic fibrosis patients, ceftazidime and aztreonam combination (+/-tobramycin, +/-ciprofloxacin) is well tolerated and efficient."	7.76	[Tolerance and efficacy of ceftazidime in combination with aztreonam for exacerbations of cystic fibrosis]. ( Leroy, S; Perez, T; Prévotat, A; Wallaert, B; Wallet, F, 2010)
"The in vitro activities of two-drug combinations of aztreonam, ciprofloxacin, and ceftazidime were studied in 96 clinical isolates of Pseudomonas aeruginosa and in 20 clinical isolates of Pseudomonas cepacia from cystic fibrosis patients."	7.68	In vitro activities of combinations of aztreonam, ciprofloxacin, and ceftazidime against clinical isolates of Pseudomonas aeruginosa and Pseudomonas cepacia from patients with cystic fibrosis. ( Bosso, JA; Matsen, JM; Saxon, BA, 1990)
"10 patients with meningitis due to unusual gram-negative organisms (Pseudomonas, Proteus, Salmonella and Klebsiella) were effectively treated with aztreonam."	7.68	Aztreonam for treating meningitis caused by gram-negative rods. ( Bishay, E; Farid, Z; Girgis, N; Kilpatrick, M, 1991)
"The in vitro activity of aztreonam and 10 other antibiotics was determined for clinical isolates of Pseudomonas aeruginosa from 18 cystic fibrosis patients obtained before, at the end of, and 7-14 days after the completion of therapy with aztreonam."	7.67	Absence of rapidly developing resistance during treatment of cystic fibrosis patients with aztreonam. ( Allen, JE; Bosso, JA; Matsen, JM; Saxon, BA, 1987)
"The in vitro activity of aztreonam combined with tobramycin and with gentamicin was assessed in 78 clinical isolates of Pseudomonas aeruginosa and 11 clinical isolates of Pseudomonas cepacia from patients with cystic fibrosis."	7.67	In vitro activity of aztreonam combined with tobramycin and gentamicin against clinical isolates of Pseudomonas aeruginosa and Pseudomonas cepacia from patients with cystic fibrosis. ( Bosso, JA; Matsen, JM; Saxon, BA, 1987)
"The therapeutic efficacies of the newer beta-lactam antibiotics piperacillin, azlocillin and aztreonam were compared with the efficacies of ticarcillin and tobramycin in a guinea pig model of experimental Pseudomonas aeruginosa pneumonia."	7.67	Comparative efficacies of piperacillin, azlocillin, ticarcillin, aztreonam, and tobramycin against experimental Pseudomonas aeruginosa pneumonia. ( Pennington, JE; Schiff, JB, 1984)
"This study examined the penetration of aztreonam into the cerebrospinal fluid (CSF) and brain in noninfected rabbits and rabbits with experimental meningitis caused by Pseudomonas aeruginosa."	7.67	Penetration of aztreonam into cerebrospinal fluid and brain of noninfected rabbits and rabbits with experimental meningitis caused by Pseudomonas aeruginosa. ( Bodem, CR; Laun, PR; Strausbaugh, LJ, 1986)
" Hospitalization rates were low and adverse events were consistent with CF."	6.75	An 18-month study of the safety and efficacy of repeated courses of inhaled aztreonam lysine in cystic fibrosis. ( Cooper, PJ; Gibson, RL; McCoy, KS; Montgomery, AB; Oermann, CM; Quittner, AL; Retsch-Bogart, GZ, 2010)
" The current dosing recommendations in the United States and Europe for aztreonam are lower than the literature supported dosing range of 200-300 mg/kg/day divided every 6 hr, maximum 8-12 g/day."	6.48	Optimization of anti-pseudomonal antibiotics for cystic fibrosis pulmonary exacerbations: I. aztreonam and carbapenems. ( Ampofo, K; Sherwin, CM; Spigarelli, MG; Stockmann, C; Waters, CD; Young, DC; Zobell, JT, 2012)
"Aztreonam is a monobactam antibacterial with bactericidal activity against a wide range of aerobic Gram-negative bacteria, including Pseudomonas aeruginosa."	6.46	Aztreonam lysine for inhalation solution: in cystic fibrosis. ( Plosker, GL, 2010)
"Aztreonam is a synthetic, monobactam antibiotic structurally related to the beta-lactam class of drugs."	5.28	Aztreonam-induced myelosuppression during treatment of Pseudomonas aeruginosa pneumonia. ( Czachor, JS; Dallal, MM, 1991)
"Ticarcillin-amikacin was the least active combination."	5.27	In vitro activities of aztreonam, piperacillin, and ticarcillin combined with amikacin against amikacin-resistant Pseudomonas aeruginosa and P. cepacia isolates from children with cystic fibrosis. ( Aronoff, SC; Klinger, JD, 1984)
" At the dosage used, aztreonam proved effective for severe urinary tract infections caused by members of the family Enterobacteriaceae in pediatric patients."	5.27	Aztreonam in the treatment of severe urinary tract infections in pediatric patients. ( Assael, BM; Boccazzi, A; Colombo, R; Crossignani, RM; Garlaschi, L; Rancilio, L; Rusconi, F, 1986)
"Concomitant use of oral azithromycin and inhaled tobramycin occurs in approximately half of US cystic fibrosis (CF) patients."	5.24	Impact of azithromycin on the clinical and antimicrobial effectiveness of tobramycin in the treatment of cystic fibrosis. ( Bratcher, PE; Caceres, SM; Chmiel, JF; Happoldt, CL; Malcolm, KC; Nichols, DP; Nick, JA; Saavedra, MT; Saiman, L; Taylor-Cousar, JL, 2017)
"To compare overall costs of treatment of chronic inhaled tobramycin and aztreonam lysine in patient with cystic fibrosis who have chronic Pseudomonas infection, taking differences in outcomes into account."	5.20	Inhaled aztreonam lysine versus inhaled tobramycin in cystic fibrosis. An economic evaluation. ( Daines, CL; Farquharson, R; Higuchi, K; Schechter, MS; Trueman, D, 2015)
"Recent studies of inhaled tobramycin in subjects with cystic fibrosis (CF) find less clinical improvement than previously observed."	5.19	Azithromycin may antagonize inhaled tobramycin when targeting Pseudomonas aeruginosa in cystic fibrosis. ( Chmiel, JF; Forssén, AV; Kim, SH; Moskowitz, SM; Nichols, DP; Nick, JA; Saavedra, MT; Saiman, L; Taylor-Cousar, JL, 2014)
"Open-label, parallel-group, international trial comparing aztreonam for inhalation solution (AZLI) and tobramycin nebulizer solution (TNS) for cystic fibrosis patients with airway Pseudomonas aeruginosa."	5.17	Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: a comparative efficacy trial. ( Assael, BM; Bilton, D; Bresnik, M; Chiron, R; Fayon, M; Fischer, R; Knoop, C; LaRosa, M; Lewis, SA; McElvaney, N; Montgomery, AB; Oermann, CM; Pressler, T, 2013)
"Aztreonam for inhalation solution (AZLI) is an inhaled antibiotic for patients with cystic fibrosis (CF) and Pseudomonas aeruginosa airway infection."	5.15	Pseudomonas aeruginosa antibiotic susceptibility during long-term use of aztreonam for inhalation solution (AZLI). ( Gibson, RL; McCoy, KS; McKevitt, M; Montgomery, AB; Oermann, CM; Retsch-Bogart, GZ, 2011)
"Previous aztreonam for inhalation solution (AZLI) studies included patients with cystic fibrosis, Pseudomonas aeruginosa (PA) airway infection, and forced expiratory volume in 1s (FEV(1)) 25% to 75% predicted."	5.15	Aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis, mild lung impairment, and P. aeruginosa. ( Geller, DE; Gibson, RL; Lewis, S; Montgomery, AB; Nakamura, C; Quittner, AL; Wainwright, CE; Wooldridge, JL, 2011)
"We assessed the short-term efficacy and safety of aztreonam lysine for inhalation (AZLI [an aerosolized monobactam antibiotic]) in patients with cystic fibrosis (CF) and Pseudomonas aeruginosa (PA) airway infection."	5.14	Efficacy and safety of inhaled aztreonam lysine for airway pseudomonas in cystic fibrosis. ( Cooper, PJ; Gibson, RL; McCoy, KS; Montgomery, AB; Oermann, CM; Quittner, AL; Retsch-Bogart, GZ, 2009)
"The effectiveness and safety of aztreonam lysine for inhalation (AZLI) in patients with cystic fibrosis (CF) on maintenance treatment for Pseudomonas aeruginosa (PA) airway infection was evaluated in this randomized, double-blind, placebo-controlled study."	5.13	Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. ( Gibson, RL; McCoy, KS; Montgomery, AB; Oermann, CM; Quittner, AL; Retsch-Bogart, GZ, 2008)
"In order to determine the optimal antipseudomonal therapy in patients with cystic fibrosis aztreonam plus amikacin was compared to ceftazidime plus amikacin, and these two-week hospital regimens were followed by oral ciprofloxacin given for four weeks."	5.06	Antipseudomonal therapy in cystic fibrosis: aztreonam and amikacin versus ceftazidime and amikacin administered intravenously followed by oral ciprofloxacin. ( Buehlmann, U; Guenin, K; Kraemer, R; Schaad, UB; Wedgwood-Krucko, J, 1989)
"The efficacy of aztreonam was compared to that of standard therapy consisting of tobramycin and azlocillin in the treatment of acute pulmonary exacerbations of cystic fibrosis in a randomized, open trial."	5.06	Controlled trial of aztreonam vs. tobramycin and azlocillin for acute pulmonary exacerbations of cystic fibrosis. ( Black, PG; Bosso, JA, 1988)
"Preclinical and clinical studies were performed to evaluate usefulness and safety of aztreonam (AZT) in the treatment of acute otitis media, acute exacerbation of chronic otitis media and chronic otitis media and the following results were obtained."	5.06	[Efficacy evaluation of aztreonam for suppurative otitis media]. ( Baba, K; Baba, S; Furuuchi, C; Kawai, T; Kinoshita, H; Maruo, T; Mori, Y; Nagae, D; Suzuki, K; Tanigaito, Y, 1986)
"Inhaled aztreonam, a newly formulated lysine salt of the original monobactam antibiotic, is approved for the treatment of respiratory symptoms in patients with cystic fibrosis (CF) who are colonized with Pseudomonas aeruginosa."	4.88	Aztreonam lysine for inhalation: new formulation of an old antibiotic. ( Brown, J; Salvas, B; Stevens, V; Zeitler, K, 2012)
"An aerosol form of aztreonam lysinate has recently been developed as a treatment for cystic fibrosis patients suffering from chronic Pseudomonas aeruginosa lung colonization."	4.87	Aztreonam inhalation solution for suppressive treatment of chronic Pseudomonas aeruginosa lung infection in cystic fibrosis. ( Assael, BM, 2011)
"Studies are required that evaluate real-world outcomes of inhaled aztreonam lysine in patients with cystic fibrosis (CF)."	3.85	A treatment evaluator tool to monitor the real-world effectiveness of inhaled aztreonam lysine in cystic fibrosis. ( Bilton, D; Downey, DG; Eustace, JA; Gunaratnam, C; Haworth, CS; Jones, AM; Ketchell, RI; McKone, EF; Peckham, DG; Plant, BJ, 2017)
"In 2010, aztreonam for inhalation solution joined aminoglycosides and colistimethate as a new cystic fibrosis (CF) chronic inhaled antimicrobial therapy."	3.81	Association between the introduction of a new cystic fibrosis inhaled antibiotic class and change in prevalence of patients receiving multiple inhaled antibiotic classes. ( Dasenbrook, EC; Konstan, MW; VanDevanter, DR, 2015)
"Aztreonam for inhalation solution (AZLI) was recently approved by the FDA for treating cystic fibrosis (CF) patients infected with Pseudomonas aeruginosa."	3.78	In vitro evaluation of tobramycin and aztreonam versus Pseudomonas aeruginosa biofilms on cystic fibrosis-derived human airway epithelial cells. ( Griffin, EF; Moreau-Marquis, S; O'Toole, GA; Schwartzman, JD; Stanton, BA; Yu, Q, 2012)
"To report the successful desensitization of a highly allergic patient with cystic fibrosis (CF) to inhaled aztreonam lysine using the novel approach of intravenous desensitization followed by full-dose inhaled therapy without any adverse reactions."	3.78	Desensitization to inhaled aztreonam lysine in an allergic patient with cystic fibrosis using a novel approach. ( Abdulhamid, I; Ditouras, J; Guglani, L; Montejo, J, 2012)
" aeruginosa colonised cystic fibrosis patients, ceftazidime and aztreonam combination (+/-tobramycin, +/-ciprofloxacin) is well tolerated and efficient."	3.76	[Tolerance and efficacy of ceftazidime in combination with aztreonam for exacerbations of cystic fibrosis]. ( Leroy, S; Perez, T; Prévotat, A; Wallaert, B; Wallet, F, 2010)
"In February 2010, aztreonam for inhalation solution (Cayston; Gilead) - an inhalable formulation of the monobactam antibiotic aztreonam and lysine - was approved by the US FDA to improve respiratory symptoms in patients with cystic fibrosis infected with Pseudomonas aeruginosa."	3.76	Inhaled aztreonam. ( Kirkpatrick, P; O'Sullivan, BP; Yasothan, U, 2010)
"10 patients with meningitis due to unusual gram-negative organisms (Pseudomonas, Proteus, Salmonella and Klebsiella) were effectively treated with aztreonam."	3.68	Aztreonam for treating meningitis caused by gram-negative rods. ( Bishay, E; Farid, Z; Girgis, N; Kilpatrick, M, 1991)
"The in vitro activities of two-drug combinations of aztreonam, ciprofloxacin, and ceftazidime were studied in 96 clinical isolates of Pseudomonas aeruginosa and in 20 clinical isolates of Pseudomonas cepacia from cystic fibrosis patients."	3.68	In vitro activities of combinations of aztreonam, ciprofloxacin, and ceftazidime against clinical isolates of Pseudomonas aeruginosa and Pseudomonas cepacia from patients with cystic fibrosis. ( Bosso, JA; Matsen, JM; Saxon, BA, 1990)
"The authors submitted 8 patients with bronchiectasis to endobronchial therapy with Aztreonam 2 gr twice a week for 4 weeks after endobronchial lavage with sodium chloride solution."	3.68	[The use of endobronchial aztreonam in the treatment of bronchiectatic suppuration]. ( Bolzan Mariotti, A; Failla, G; Lavorgna, F; Matzeu, M; Mosillo, M, 1990)
"This study examined the penetration of aztreonam into the cerebrospinal fluid (CSF) and brain in noninfected rabbits and rabbits with experimental meningitis caused by Pseudomonas aeruginosa."	3.67	Penetration of aztreonam into cerebrospinal fluid and brain of noninfected rabbits and rabbits with experimental meningitis caused by Pseudomonas aeruginosa. ( Bodem, CR; Laun, PR; Strausbaugh, LJ, 1986)
"The in vitro activity of aztreonam combined with tobramycin and with gentamicin was assessed in 78 clinical isolates of Pseudomonas aeruginosa and 11 clinical isolates of Pseudomonas cepacia from patients with cystic fibrosis."	3.67	In vitro activity of aztreonam combined with tobramycin and gentamicin against clinical isolates of Pseudomonas aeruginosa and Pseudomonas cepacia from patients with cystic fibrosis. ( Bosso, JA; Matsen, JM; Saxon, BA, 1987)
"The in vitro activity of aztreonam and 10 other antibiotics was determined for clinical isolates of Pseudomonas aeruginosa from 18 cystic fibrosis patients obtained before, at the end of, and 7-14 days after the completion of therapy with aztreonam."	3.67	Absence of rapidly developing resistance during treatment of cystic fibrosis patients with aztreonam. ( Allen, JE; Bosso, JA; Matsen, JM; Saxon, BA, 1987)
"The therapeutic efficacies of the newer beta-lactam antibiotics piperacillin, azlocillin and aztreonam were compared with the efficacies of ticarcillin and tobramycin in a guinea pig model of experimental Pseudomonas aeruginosa pneumonia."	3.67	Comparative efficacies of piperacillin, azlocillin, ticarcillin, aztreonam, and tobramycin against experimental Pseudomonas aeruginosa pneumonia. ( Pennington, JE; Schiff, JB, 1984)
" Hospitalization rates were low and adverse events were consistent with CF."	2.75	An 18-month study of the safety and efficacy of repeated courses of inhaled aztreonam lysine in cystic fibrosis. ( Cooper, PJ; Gibson, RL; McCoy, KS; Montgomery, AB; Oermann, CM; Quittner, AL; Retsch-Bogart, GZ, 2010)
" The current dosing recommendations in the United States and Europe for aztreonam are lower than the literature supported dosing range of 200-300 mg/kg/day divided every 6 hr, maximum 8-12 g/day."	2.48	Optimization of anti-pseudomonal antibiotics for cystic fibrosis pulmonary exacerbations: I. aztreonam and carbapenems. ( Ampofo, K; Sherwin, CM; Spigarelli, MG; Stockmann, C; Waters, CD; Young, DC; Zobell, JT, 2012)
"Aztreonam is a monobactam antibacterial with bactericidal activity against a wide range of aerobic Gram-negative bacteria, including Pseudomonas aeruginosa."	2.46	Aztreonam lysine for inhalation solution: in cystic fibrosis. ( Plosker, GL, 2010)
"Within 6 months, he redeveloped a thoracic aortic aneurysm, necessitating reoperation and lifelong parenteral antibiotic therapy."	2.41	Mycotic aneurysm of the descending thoracic aorta caused by Pseudomonas aeruginosa in a solid organ transplant recipient: case report and review. ( Beilman, GJ; Feltis, BA; Lee, DA, 2002)
" In the treatment of children with urinary tract infection as well as other types of infections, aztreonam therapy in a dosage of 30 mg/kg given every 6 to 8 hours was associated with satisfactory clinical and microbiologic cure rates."	2.38	Clinical experience with aztreonam. ( Stutman, HR, 1989)
" This study evaluated in vitro antimicrobial synergy of ceftolozane/tazobactam in combination with aztreonam and fosfomycin against MDR PSA."	1.56	In vitro synergy of ceftolozane/tazobactam in combination with fosfomycin or aztreonam against MDR Pseudomonas aeruginosa. ( Cayô, R; Cuba, GT; Gales, AC; Kiffer, CRV; Nicolau, DP; Nodari, CS; Pignatari, ACC; Rocha-Santos, G; Streling, AP, 2020)
"Pseudomonas aeruginosa is related to nosocomial infections, and it tends to become resistant during or after antimicrobial treatment."	1.51	In vitro interaction of various antibiotic combinations recommended by Chinese consensus statement against carbapenems-resistant Pseudomonas aeruginosa. ( Li, J; Ma, W; Sun, S; Wang, D; Yu, C, 2019)
" A humanized aztreonam dose of 2 g every 6 h (1-h infusion) was evaluated alone and in combination with avibactam at 375 or 600 mg every 6 h (1-h infusion), targeting the percentage of the dosing interval in which free-drug concentrations remained above the MIC (fT>MIC)."	1.39	Human simulated studies of aztreonam and aztreonam-avibactam to evaluate activity against challenging gram-negative organisms, including metallo-β-lactamase producers. ( Crandon, JL; Nicolau, DP, 2013)
"Aztreonam was not hydrolyzed."	1.39	FIM-1, a new acquired metallo-β-lactamase from a Pseudomonas aeruginosa clinical isolate from Italy. ( Docquier, JD; Luzzaro, F; Maradei, S; Olivo, G; Pecile, P; Pollini, S; Rossolini, GM, 2013)
" The superiority of aerosol dosing over systemic dosing was demonstrated in models of both acute and chronic lung infection."	1.35	Efficacy of aerosol MP-376, a levofloxacin inhalation solution, in models of mouse lung infection due to Pseudomonas aeruginosa. ( Dudley, MN; Griffith, DC; Miller, CE; Nolan, TG; Sabet, M; Senekeo-Effenberger, K, 2009)
"Aztreonam and amikacin were intravenously administered at doses of 2 g/day and 800 mg/day, respectively."	1.35	[Infection treatment caused by multiple-drug-resistant Pseudomonas aeruginosa in a patient undergoing allogeneic hematopoietic stem cell transplantation]. ( Fukuoka, N; Houchi, H; Inoue, T; Ishida, T; Kaji, M; Kawazoe, H; Ninomiya, M; Ohnishi, H; Takiguchi, Y; Tanaka, H; Tsuji, S; Yamaguchi, K, 2008)
"Piperacillin/tazobactam was the only effective drug in antimicrobial susceptibility testing."	1.34	Molecular epidemiology of clinical Pseudomonas aeruginosa isolates carrying IMP-1 metallo-beta-lactamase gene in a University Hospital in Turkey. ( Aydin, K; Caylan, R; Koksal, I; Ozgumus, OB; Sandalli, C; Tosun, I, 2007)
"aeruginosa burn wound infection, aztreonam and piperacillin should be considered as the first line of defense."	1.30	The use of aztreonam as an alternate therapy for multi-resistant Pseudomonas aeruginosa. ( Heggers, JP; Herndon, DN; Villarreal, C; Walton, MA, 1997)
"Aztreonam is a synthetic, monobactam antibiotic structurally related to the beta-lactam class of drugs."	1.28	Aztreonam-induced myelosuppression during treatment of Pseudomonas aeruginosa pneumonia. ( Czachor, JS; Dallal, MM, 1991)
"Ticarcillin-amikacin was the least active combination."	1.27	In vitro activities of aztreonam, piperacillin, and ticarcillin combined with amikacin against amikacin-resistant Pseudomonas aeruginosa and P. cepacia isolates from children with cystic fibrosis. ( Aronoff, SC; Klinger, JD, 1984)
" At the dosage used, aztreonam proved effective for severe urinary tract infections caused by members of the family Enterobacteriaceae in pediatric patients."	1.27	Aztreonam in the treatment of severe urinary tract infections in pediatric patients. ( Assael, BM; Boccazzi, A; Colombo, R; Crossignani, RM; Garlaschi, L; Rancilio, L; Rusconi, F, 1986)
" The elimination half-life varied inversely, and the clearance from serum varied directly, with age."	1.27	Single-dose pharmacokinetics of aztreonam in pediatric patients. ( Marks, MI; Stutman, HR; Swabb, EA, 1984)
"Aztreonam was used for a year to treat 106 hospitalized patients with a total of 131 documented gram-negative infections."	1.27	Treatment of serious gram-negative infections with aztreonam. ( Bollinger, M; Darji, TB; Greenberg, RN; Luppen, KL; McMillian, R; Noorani, AA; Reilly, PM; Wolk, SM, 1984)
"Cefsulodin alone was even less active but similar to aztreonam synergistically."	1.27	In vitro studies of investigational beta-lactams as possible therapy for Pseudomonas aeruginosa endocarditis. ( Kany, RJ; Zar, FA, 1985)
"Aztreonam is a novel antimicrobial agent belonging to the monobactam class of antibiotics."	1.27	Use of aztreonam in the treatment of serious infections due to multiresistant gram-negative organisms, including Pseudomonas aeruginosa. ( Neu, HC; Scully, BE, 1985)

Research

Studies (119)

Authors

Clinical Trials (11)

Trial Overview

Trial Outcomes

Percentage of Participants With PA-negative Cultures at All Time Points After Cessation of Active Treatment (Evaluable Analysis Set)

Timeframe	Studies, this research(%)	All Research%
pre-1990	29 (24.37)	18.7374
1990's	13 (10.92)	18.2507
2000's	15 (12.61)	29.6817
2010's	53 (44.54)	24.3611
2020's	9 (7.56)	2.80

Authors	Studies
Chen, M	1
Cai, H	1
Li, Y	1
Wang, N	1
Zhang, P	1
Hua, X	1
Yu, Y	1
Sun, R	1
Hernando-Amado, S	1
López-Causapé, C	2
Laborda, P	1
Sanz-García, F	1
Oliver, A	2
Martínez, JL	1
Ding, L	1
Sun, Y	1
Zhang, Y	1
Shen, S	1
Hu, F	1
Do Rego, H	1
Timsit, JF	1
Betts, JW	1
Hornsey, M	1
Higgins, PG	1
Lucassen, K	1
Wille, J	1
Salguero, FJ	1
Seifert, H	1
La Ragione, RM	1
Paul, D	1
Chanda, DD	1
Chakravarty, A	1
Bhattacharjee, A	1
Yan, J	1
Estanbouli, H	1
Liao, C	1
Kim, W	1
Monk, JM	1
Rahman, R	1
Kamboj, M	1
Palsson, BO	1
Qiu, W	1
Xavier, JB	1
Cuba, GT	1
Rocha-Santos, G	1
Cayô, R	1
Streling, AP	1
Nodari, CS	1
Gales, AC	1
Pignatari, ACC	1
Nicolau, DP	2
Kiffer, CRV	1
Frost, F	1
Young, GR	1
Wright, L	1
Miah, N	1
Smith, DL	1
Winstanley, C	1
Walshaw, MJ	1
Fothergill, JL	1
Nazareth, D	1
Clark, ST	1
Stapleton, PJ	1
Wang, PW	1
Yau, YCW	1
Waters, VJ	1
Hwang, DM	1
Guttman, DS	1
Mularoni, A	1
Mezzatesta, ML	1
Pilato, M	1
Medaglia, AA	1
Cervo, A	1
Bongiorno, D	1
Aprile, A	1
Luca, A	1
Stefani, S	1
Grossi, P	1
Plant, BJ	1
Downey, DG	1
Eustace, JA	1
Gunaratnam, C	1
Haworth, CS	1
Jones, AM	1
McKone, EF	1
Peckham, DG	1
Ketchell, RI	1
Bilton, D	2
Heirali, AA	2
Workentine, ML	2
Acosta, N	2
Poonja, A	1
Storey, DG	2
Somayaji, R	2
Rabin, HR	2
Whelan, FJ	1
Surette, MG	2
Parkins, MD	4
Mittal, J	1
Szymczak, WA	1
Guo, Y	1
Levi, MH	1
Chen, L	1
Kreiswirth, BN	1
Riska, PF	1
Nori, P	1
Casciaro, B	1
Loffredo, MR	1
Luca, V	1
Verrusio, W	1
Cacciafesta, M	1
Mangoni, ML	1
Laforest-Lapointe, I	1
Leung, W	1
Quon, BS	1
Berthiaume, Y	1
Waddell, BJ	1
Rossi, L	1
Ma, W	1
Li, J	1
Wang, D	1
Yu, C	1
Sun, S	1
McLean, K	1
Lee, D	1
Holmes, EA	1
Penewit, K	1
Waalkes, A	1
Ren, M	1
Lee, SA	1
Gasper, J	1
Manoil, C	1
Salipante, SJ	1
Máiz, L	1
Girón, RM	1
Olveira, C	1
Quintana, E	1
Lamas, A	1
Pastor, D	1
Cantón, R	2
Mensa, J	1
Crandon, JL	1
Hutchinson, D	1
Barclay, M	1
Prescott, WA	1
Brown, J	2
Nick, JA	2
Moskowitz, SM	1
Chmiel, JF	2
Forssén, AV	1
Kim, SH	1
Saavedra, MT	2
Saiman, L	2
Taylor-Cousar, JL	2
Nichols, DP	2
Nakamura, I	1
Yamaguchi, T	1
Tsukimori, A	1
Sato, A	1
Fukushima, S	1
Mizuno, Y	1
Matsumoto, T	1
Fiel, SB	1
Tiddens, HA	3
De Boeck, K	1
Clancy, JP	2
Fayon, M	2
H G M, A	1
Bresnik, M	3
Derchak, A	1
Lewis, SA	3
Oermann, CM	6
Hansen, C	1
Skov, M	1
Dasenbrook, EC	1
Konstan, MW	1
VanDevanter, DR	1
Bos, AC	1
van Holsbeke, C	1
de Backer, JW	1
van Westreenen, M	1
Janssens, HM	1
Vos, WG	1
Dupont, H	1
Marciniak, S	1
Zogheib, E	1
Mammeri, H	1
Friggeri, A	1
Ammenouche, N	1
Levrard, M	1
Airapetian, N	1
Tinturier, F	1
Mahjoub, Y	1
Schechter, MS	1
Trueman, D	1
Farquharson, R	1
Higuchi, K	1
Daines, CL	1
Kazmierczak, KM	1
Rabine, S	1
Hackel, M	1
McLaughlin, RE	1
Biedenbach, DJ	1
Bouchillon, SK	1
Sahm, DF	1
Bradford, PA	1
Rojo-Molinero, E	1
Macià, MD	1
Rubio, R	1
Moyà, B	1
Cabot, G	1
Pérez, JL	1
Flume, PA	2
Retsch-Bogart, GZ	6
Tullis, DE	1
Derchak, PA	1
Ramsey, BW	1
Fjaellegaard, K	1
Sin, MD	1
Browatzki, A	1
Ulrik, CS	1
Yamagishi, Y	1
Hagihara, M	1
Kato, H	1
Hirai, J	1
Nishiyama, N	1
Koizumi, Y	1
Sakanashi, D	1
Suematsu, H	1
Nakai, H	1
Mikamo, H	1
Happoldt, CL	1
Bratcher, PE	1
Caceres, SM	1
Malcolm, KC	1
Sy, S	1
Zhuang, L	1
Xia, H	1
Beaudoin, ME	1
Schuck, VJ	1
Derendorf, H	1
McCoy, KS	4
Quittner, AL	4
Gibson, RL	6
Montgomery, AB	6
Araoka, H	2
Baba, M	2
Tatsushima, K	1
Takagi, S	1
Matsuno, N	1
Wake, A	1
Taniguchi, S	1
Yoneyama, A	2
Torres, E	1
Villanueva, R	1
Bou, G	1
Cooper, PJ	2
Sabet, M	1
Miller, CE	1
Nolan, TG	1
Senekeo-Effenberger, K	1
Dudley, MN	1
Griffith, DC	1
Kotsakis, SD	1
Papagiannitsis, CC	1
Tzelepi, E	1
Legakis, NJ	1
Miriagou, V	1
Tzouvelekis, LS	1
Mogayzel, PJ	1
Elborn, JS	2
Henig, NR	1
O'Sullivan, BP	1
Yasothan, U	1
Kirkpatrick, P	1
Prévotat, A	1
Leroy, S	1
Perez, T	1
Wallet, F	1
Wallaert, B	1
Plosker, GL	1
Wainwright, CE	1
Geller, DE	2
Nakamura, C	1
Wooldridge, JL	1
Lewis, S	1
Belavic, JM	1
McKevitt, M	1
Assael, BM	3
Ballmann, M	1
Smyth, A	1
Zeitler, K	1
Salvas, B	1
Stevens, V	1
Tateda, K	1
Ishii, Y	1
Oguri, T	1
Okuzumi, K	1
Oishi, T	1
Mori, S	1
Mitsuda, T	1
Moriya, K	1
Nakamori, Y	1
Ohmagari, N	1
Yamaguchi, K	2
Whitaker, P	1
Etherington, C	1
Williams, K	1
Conway, S	1
Peckham, D	1
Santoro, DO	1
Romão, CM	1
Clementino, MM	1
Littlewood, KJ	1
Higashi, K	1
Jansen, JP	1
Capkun-Niggli, G	1
Balp, MM	1
Doering, G	1
Angyalosi, G	1
Yu, Q	1
Griffin, EF	1
Moreau-Marquis, S	1
Schwartzman, JD	1
Stanton, BA	1
O'Toole, GA	1
Zobell, JT	1
Young, DC	1
Waters, CD	1
Stockmann, C	1
Ampofo, K	1
Sherwin, CM	1
Spigarelli, MG	1
Pressler, T	1
Fischer, R	1
Chiron, R	1
LaRosa, M	1
Knoop, C	1
McElvaney, N	1
Goss, CH	1
Bell, SC	1
Guglani, L	1
Abdulhamid, I	1
Ditouras, J	1
Montejo, J	1
Pollini, S	1
Maradei, S	1
Pecile, P	1
Olivo, G	1
Luzzaro, F	1
Docquier, JD	1
Rossolini, GM	1
Fernández, AB	1
Pérez, M	1
Soto, L	1
Feltis, BA	1
Lee, DA	1
Beilman, GJ	1
Wang, JZ	1
Nightingale, CH	1
Sweeney, KS	1
Xi, NZ	1
Wang, DM	1
Tiddens, H	1
Poirel, L	1
Brinas, L	1
Fortineau, N	1
Nordmann, P	1
Guerin, F	1
Henegar, C	1
Spiridon, G	1
Launay, O	1
Salmon-Ceron, D	1
Poyart, C	1
Pitout, JDD	1
Church, DL	1
Conly, JM	1
Laupland, KB	1
Gasink, LB	1
Fishman, NO	1
Nachamkin, I	1
Bilker, WB	1
Lautenbach, E	1
Ozgumus, OB	1
Caylan, R	1
Tosun, I	1
Sandalli, C	1
Aydin, K	1
Koksal, I	1
Burns, JL	1
Otto, KL	1
Liou, TG	1
McCoy, K	1
Oermann, C	1
Kawazoe, H	1
Takiguchi, Y	1
Inoue, T	1
Tanaka, H	1
Kaji, M	1
Tsuji, S	1
Ninomiya, M	1
Fukuoka, N	1
Ohnishi, H	1
Ishida, T	1
Houchi, H	1
Schiff, JB	1
Pennington, JE	1
Stutman, HR	2
Marks, MI	1
Swabb, EA	1
Greenberg, RN	1
Reilly, PM	1
Luppen, KL	1
McMillian, R	1
Bollinger, M	1
Wolk, SM	1
Darji, TB	1
Noorani, AA	1
Aronoff, SC	1
Klinger, JD	1
Bonner, DP	1
Whitney, RR	1
Baughn, CO	1
Miller, BH	1
Olsen, SJ	1
Sykes, RB	1
Pefanis, A	1
Giamarellou, H	1
Karayiannakos, P	1
Donta, I	1
Turcotte, A	1
Simard, M	1
Morin, NJ	1
Beauchamp, D	1
Bergeron, MG	1
Walton, MA	1
Villarreal, C	1
Herndon, DN	1
Heggers, JP	1
Ernst, EJ	1
Hashimoto, S	1
Guglielmo, J	1
Sawa, T	1
Pittet, JF	1
Kropp, H	1
Jackson, JJ	1
Wiener-Kronish, JP	1
Oie, S	1
Sawa, A	1
Kamiya, A	1
Mizuno, H	1
Iakovlev, VP	1
McGrath, BJ	1
Bailey, EM	1
Lamp, KC	1
Rybak, MJ	1
Fayed, DF	1
Dahmash, NS	1
Saddique, AA	1
Shibl, AM	1
Dallal, MM	1
Czachor, JS	1
Kilpatrick, M	1
Girgis, N	1
Farid, Z	1
Bishay, E	1
Bosso, JA	6
Saxon, BA	3
Matsen, JM	5
Matzeu, M	1
Failla, G	1
Bolzan Mariotti, A	1
Mosillo, M	1
Lavorgna, F	1
Gould, FK	1
Venning, MC	1
Ford, M	1
Allen, KD	1
Green, HT	1
Allen, JE	2
Seginková, Z	1
Krcméry, V	1
Antal, M	1
Knothe, H	1
Schaad, UB	1
Wedgwood-Krucko, J	1
Guenin, K	1
Buehlmann, U	1
Kraemer, R	1
Walker, EM	1
Hardin, HF	1
Gale, GR	1
Reifsteck, ME	1
Cannon, DJ	1
Jones, MM	1
Donegani, E	1
di Summa, M	1
Agaccio, G	1
Comoglio, C	1
De Paulis, R	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis. An Randomised, Crossover Pilot Study of AZLI Plus Intravenous Colistin® Versus Standard Dual Intravenous Therapy[NCT02894684]	Phase 4	16 participants (Actual)	Interventional	2017-01-31	Completed
Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients With Cystic Fibrosis (CF) and New Onset Lower Respiratory Tract Cultur[NCT01375049]	Phase 2	105 participants (Actual)	Interventional	2011-08-31	Completed
Functional Respiratory Imaging During Pulmonary Exacerbations in Adults With Non-cystic Fibrosis Bronchiectasis[NCT03818646]		10 participants (Anticipated)	Observational	2019-01-31	Not yet recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas Aeruginosa I[NCT01641822]	Phase 3	107 participants (Actual)	Interventional	2012-12-31	Completed
Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Non-cystic Fibrosis Bronchiectasis: a Cross-over, Unicentric, Double-blind and Placebo-controlled Study[NCT03988816]	Phase 2	30 participants (Anticipated)	Interventional	2019-12-06	Recruiting
Efficacy, Safety and Pharmacokinetics Profile of Nebulized Aztreonam Lysine (AZLI) for Prevention of Gram Negative Pneumonia in Heavily Colonized Mechanically Ventilated Patients[NCT03749226]	Phase 2/Phase 3	9 participants (Actual)	Interventional	2019-03-19	Terminated (stopped due to due to COVID-19 pandemia)
Aztreonam Lysine for Inhalation (AZLI) in the Treatment of Early Bronchiolitis Obliterans Syndrome (BOS) After Lung Transplantation[NCT01469364]	Phase 4	30 participants (Actual)	Interventional	2013-03-31	Completed
A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2)[NCT00104520]	Phase 3	211 participants (Actual)	Interventional	2005-02-28	Completed
A Phase 3, Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary Pseudomonas Aeruginosa (AIR-CF1)[NCT00112359]	Phase 3	166 participants (Actual)	Interventional	2005-05-31	Completed
A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine For Inhalation in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa (AIR-CF4)[NCT00712166]	Phase 3	160 participants (Actual)	Interventional	2008-05-31	Completed
An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam for Inhalation Solution (AZLI) Versus Tobramycin Inhalation Solution (TIS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects With Cystic Fibrosis Followe[NCT00757237]	Phase 3	274 participants (Actual)	Interventional	2008-08-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

The percentage of participants with PA-negative cultures at all time points after cessation of active treatment at Day 28 (assessed at Days 56, 112, and 196) was summarized for the Evaluable Analysis Set. (NCT01375049)
Timeframe: Day 28 to Day 196

Percentage of Participants With PA-negative Cultures at All Time Points After Cessation of Active Treatment (Sensitivity Analysis Set)

Intervention	percentage of participants (Number)
AZLI - Evaluable Analysis Set	58.2

The percentage of participants with PA-negative cultures at all time points after cessation of active treatment at Day 28 (assessed at Days 56, 112, and 196) was summarized for the Sensitivity Analysis Set. (NCT01375049)
Timeframe: Day 28 to Day 196

Change From Baseline in Body Mass Index (BMI)

Change From Baseline in CFQ-R RSS Score

Intervention	percentage of participants (Number)
AZLI - Sensitivity Analysis Set	46.9

Intervention	kg/m^2 (Mean)
	Change at Day 28 (On-Treatment, n = 104)	Change at Day 56 (Posttreatment, n = 101)	Change at Day 112 (Posttreatment, n = 90)	Change at Day 196 (Posttreatment, n = 69)
AZLI	0.1	0.1	0.0	0.0

Respiratory symptoms (eg, coughing, congestion, wheezing) were assessed with the Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) only in participants ≥ 6 years of age. The range of scores (units) is 0 to 100 with higher scores indicating fewer symptoms. (NCT01375049)
Timeframe: Baseline to Days 28, 56, 112, and 196

Change From Baseline in FEV1% Predicted

Intervention	units on a scale (Mean)
	Change at Day 28 (n=24 [met], 29 [did not meet])	Change at Day 56 (n=24 [met], 27 [did not meet])	Change at Day 112 (n=24 [met], 21 [did not meet])	Change at Day 196 (n=24 [met], 10 [did not meet])
AZLI - Did Not Meet Primary Efficacy Endpoint	5.36	6.17	1.46	5.83
AZLI - Met Primary Efficacy Endpoint	8.33	6.37	5.79	6.13

Spirometry assessments were performed only in participants ≥ 6 years of age. Forced expiratory volume in 1 second (FEV1) % predicted was defined as FEV1 of the participant divided by the average FEV1 in the population for any person of similar age, sex and body composition. (NCT01375049)
Timeframe: Baseline to Days 28, 56, 112, and 196

Change From Baseline in Height

Change From Baseline in Weight

Percentage of Participants With PA-negative Cultures

Intervention	percentage of FEV1% predicted (Mean)
	Change at Day 28 (n=25 [met], 26 [did not meet])	Change at Day 56 (n=25 [met], 26 [did not meet])	Change at Day 112 (n=25 [met], 19 [did not meet])	Change at Day 196 (n=25 [met], 8 [did not meet])
AZLI - Did Not Meet Primary Efficacy Endpoint	-0.38	-4.24	-5.10	-8.85
AZLI - Met Primary Efficacy Endpoint	-0.23	-0.20	0.32	-2.47

Intervention	cm (Mean)
	Change at Day 28 (On-Treatment, n = 104)	Change at Day 56 (Posttreatment, n = 101)	Change at Day 112 (Posttreatment, n = 90)	Change at Day 196 (Posttreatment, n = 69)
AZLI	0.6	1.4	2.6	4.5

Intervention	kg (Mean)
	Change at Day 28 (On-Treatment, n = 104)	Change at Day 56 (Posttreatment, n = 101)	Change at Day 112 (Posttreatment, n = 90)	Change at Day 196 (Posttreatment, n = 69)
AZLI	0.3	0.5	0.8	1.5

The percentage of participants with a PA-negative culture was summarized at each visit. (NCT01375049)
Timeframe: Days 28, 56, 112, and 196

Pharmacokinetics (PK) Peak and Trough Plasma Concentrations of Aztreonam

Intervention	percentage of participants (Number)
	Day 28	Day 56	Day 112	Day 196
AZLI	89.1	75.2	63.4	47.5

The plasma concentration of aztreonam for participants < 6 years of age was obtained 1 hour after the first dose of AZLI on Day 1 and immediately prior to the last dose of AZLI on Day 28. (NCT01375049)
Timeframe: Day 1 (1 hour postdose) and Day 28 (immediately prior to dosing)

Use of Additional (Non-study) Antipseudomonal Antibiotics

Intervention	ng/mL (Mean)
	Day 1 (1 hour postdose, n = 40)	Day 28 (immediately prior to dosing, n = 43)
AZLI	578	125

The percentage of participants who used additional (non-study) antipseudomonal antibiotics (an indication of PA exacerbation) while on treatment and posttreatment was summarized. (NCT01375049)
Timeframe: Baseline to Day 196

Average Actual Change From Baseline in FEV1 % Predicted Across All Courses of AZLI/Placebo Treatment (Weeks 4, 12 and 20)

Intervention	percentage of participants (Number)
	On-treatment	Posttreatment
AZLI	1.9	43.8

FEV1 % predicted is defined as FEV1 of the patient divided by the average FEV1 in the population for any person of similar age, sex and body composition. The adjusted mean is from a mixed-effect model repeated measures (MMRM) analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction. (NCT01641822)
Timeframe: Comparative Phase: Baseline and Weeks 4, 12 and 20

Average Change From Baseline in the CFQ-R Respiratory Symptom Scale (RSS) Score Across All Courses of AZLI/Placebo Treatment (Weeks 4, 12 and 20)

Intervention	percentage of FEV1 % predicted (Mean)
AZLI	1.37
Placebo	0.04

Respiratory symptoms (eg, coughing, congestion, wheezing) were assessed with the Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS). The range of scores (units) was 0 to 100 with higher scores indicating fewer symptoms. The adjusted mean is from a mixed-effect model repeated measures (MMRM) analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction. (NCT01641822)
Timeframe: Comparative Phase: Baseline and Weeks 4, 12 and 20

Percentage of Participants Who Used Non-study IV or Inhaled Antibiotics for PDEs

Intervention	units on a scale (Mean)
AZLI	1.00
Placebo	-2.06

(NCT01641822)
Timeframe: Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days)

Rate of Hospitalizations for a Respiratory Event

Intervention	percentage of participants (Number)
AZLI	48.8
Placebo	55.3

The rate of hospitalizations for a respiratory event per participant year was calculated using negative binomial regression analysis. (NCT01641822)
Timeframe: Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days)

Rate of Protocol-defined Exacerbations (PDE) From Baseline Through Week 24

Intervention	hospitalizations per participant year (Number)
AZLI	1.043
Placebo	1.624

PDEs were characterized by a change or worsening from baseline of 1 or more documented signs or symptoms (decreased exercise tolerance, increased cough, increased sputum or chest congestion, decreased appetite, or other signs or symptoms) associated with the use of non-study IV or inhaled antibiotics and be verified by a blinded independent adjudication committee. (NCT01641822)
Timeframe: Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days)

Time to First Protocol-defined Pulmonary Exacerbation

Intervention	PDEs per participant year (Number)
AZLI	1.309
Placebo	1.762

The time to first protocol-defined pulmonary exacerbation was calculated using the Kaplan-Meier method. (NCT01641822)
Timeframe: Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days)

Bronchoalveolar Lavage Fluid (BALF) Neutrophilia After Treatment, When Performed as Part of Clinical Care (SOC).

Intervention	days (Median)
AZLI	175
Placebo	140.0

The study team is measuring the change in neutrophils AFTER treatment. They will compare a SOC BAL taken after AZLI with the BAL taken within 90 days of AZLI initiation (pre or baseline measure). The post AZLI BAL measurement time range is 15 days after first course of AZLI up to last day of the 3rd and final course of AZLI (over a period of 5 consecutive months). (NCT01469364)
Timeframe: Baseline - defined as a within 90 days of enrollment and After Treatment (5 months)

Change in Pulmonary Function, as Measured by Serial Forced Expiratory Flow (FEF25-75) on Spirometry at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1

Intervention	mean percentage of neutrophils (Mean)
Aztreonam Lysine for Inhalation (AZLI)	7.80

Within-subject change to absolute FEF 25-75 month 1 vs. 0. FEF 25-75 was measured 14-35 days after the start of months 1 (NCT01469364)
Timeframe: Baseline, month 1

Change in Pulmonary Function, as Measured by Serial Forced Expiratory Flow (FEF25-75) on Spirometry at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 5.

Intervention	Liter (Median)
Aztreonam Lysine for Inhalation (AZLI)	-0.025

Within-subject change to absolute FEF 25-75 month 5 vs 0. FEF 25-75 was measured 14-35 days after the start of months 5 (NCT01469364)
Timeframe: Baseline, month 5

Change in Pulmonary Function, as Measured by Serial Forced Expiratory Volume in 1 Second (FEV1) on Spirometry

Intervention	Liter (Median)
Aztreonam Lysine for Inhalation (AZLI)	-0.015

Within-subject change to absolute FEV1 month 1 vs. 0. FEV1 was measured 14-35 days after the start of months 1 AZLI courses and compared to study month 0 (baseline/prior to 1st dose). (NCT01469364)
Timeframe: Baseline, month 1

Change in Pulmonary Function, as Measured by Serial Forced Expiratory Volume in 1 Second (FEV1) on Spirometry

Intervention	Liter (Median)
Aztreonam Lysine for Inhalation (AZLI)	-0.04

Within-subject change to absolute FEV1 month 5 vs 0. (NCT01469364)
Timeframe: Baseline, month 5

Change in Respiratory-specific Health Related Quality of Life, Measured by Serially Self Administered St. George's Respiratory Questionnaire (SGRQ) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1

Intervention	Liter (Median)
Aztreonam Lysine for Inhalation (AZLI)	-0.02

The SRGQ measures activities, symptoms, and impacts of living with a pulmonary condition. We analyzed the change to the within-subject Total score month 1 vs. 0. Total score ranges from 0-100 with a smaller value representing better respiratory-specific QOL. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference in the Total Score. The SGRQ was completed 14-35 days after the start of months 1 AZLI courses and compared to study month 0 (baseline/prior to 1st dose). (NCT01469364)
Timeframe: Baseline, month 1

Intervention	units on a scale (Median)
Aztreonam Lysine for Inhalation (AZLI)	0.82

The SRGQ measures activities, symptoms, and impacts of living with a pulmonary condition. We analyzed the change to the within-subject Total score month 5 vs 0. Total score ranges from 0-100 with a smaller value representing better respiratory-specific QOL. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference in theTotal Score. The SGRQ was completed 14-35 days after the start of month 5 AZLI courses and compared to study month 0 (baseline/prior to 1st dose). (NCT01469364)
Timeframe: Baseline, month 5

Among Patients Colonized With Pseudomonas Aeruginosa, Change in Infection Burden as Measured by the Culture Final Report (0,1+, 2+, 3+, 4+) of in Pseudomonas Aeruginosa Sputum or Bronchoalveolar Fluid.

Intervention	units on a scale (Median)
Aztreonam Lysine for Inhalation (AZLI)	0.15

Microbiology data was collected when performed for SOC purposes on BAL or sputum samples. Baseline and 1 month value represents the culture final report value (0,1+, 2+, 3+, 4+) of Pseudomonas aeruginosa. A value of zero represents no Pseudomonas aeruginosa sputum or bronchoalveolar fluid. A value of 4 represents high amounts of Pseudomonas aeruginosa sputum or bronchoalveolar fluid. (NCT01469364)
Timeframe: Baseline, month 1

Change in Global Health Related Quality of Life, Measured by Serially Self-administered Short Form 36 Health Survey Questionnaire (SF-36) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1

Intervention	culture value of Pseudomonas aeruginosa (Number)
	Culture value at Baseline	Culture value at one month
Aztreonam Lysine for Inhalation (AZLI)	4	0

The SF-36 is a commonly used, well validated measure of global health related quality of life. The survey was self-administered. There are 8 subscales which combine to form a Physical Component Score (PCS) and a Mental Component Score (MCS). We analyzed within subject changes to the PCS and MCS at month 1 vs. 0. MCS and PCS scores are relative to a US population mean of 50. The higher the score, the better one perceives his quality of life. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference. The SF-36 was completed 14-35 days after the start of months 1 AZLI courses and compared to study month 0 (baseline/prior to 1st dose). (NCT01469364)
Timeframe: Baseline, month 1

Intervention	units on a scale (Median)
	PCS: month 1 vs. Baseline (n=28)	MCS: month 1 vs. Baseline (n-28)
Aztreonam Lysine for Inhalation (AZLI)	-1.52	0.78

The SF-36 is a commonly used, well validated measure of global health related quality of life. The survey was self-administered. There are 8 subscales which combine to form a Physical Component Score (PCS) and a Mental Component Score (MCS). We analyzed within subject changes to the PCS and MCS at month 5 vs 0. MCS and PCS scores are relative to a US population mean of 50. The higher the score, the better one perceives his quality of life. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference. The SF-36 was completed 14-35 days after the start of months 1 and 5 AZLI courses and compared to study month 0 (baseline/prior to 1st dose). (NCT01469364)
Timeframe: Baseline, month 5

Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum

Intervention	units on a scale (Median)
	PCS: month 5 vs. Baseline (n=26)	MCS: month 5 vs. Baseline (n-26)
Aztreonam Lysine for Inhalation (AZLI)	1.62	-1.24

Sputum samples were collected at all participant visits of the study for analysis of microbiology endpoints. Sputum samples were processed for qualitative and quantitative culture of PA (each morphotype). Due to the skewness of the distribution of CFU data, the data were transformed using the base 10 logarithm, in an attempt to normalize the data and allow for parametric tests, before calculating changes. To account for zero values, 1 was added to each CFU measurement before being transformed. Any CFU data values where PA was not isolated from a valid culture were set to zero. (NCT00104520)
Timeframe: Day 0 to Day 28

Change in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score

Intervention	Log10 PA CFUs/gram of sputum (Least Squares Mean)
Placebo (Pooled BID/TID)	0.225
AZLI (Pooled BID/TID)	-0.434

The CFQ-R was administered at Day -28, baseline, Day 14, Day 28, and Day 84 (end of study). The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores [units]: 0-100; higher scores indicate fewer symptoms). (NCT00104520)
Timeframe: Day 0 to Day 28

Number of Hospitalization Days

Intervention	Units on a scale (Least Squares Mean)
Placebo (Pooled BID/TID)	-0.66
AZLI (Pooled BID/TID)	4.34

Details of all hospitalizations, including the dates of admission and discharge, were recorded on the electronic case report form (eCRF). (NCT00104520)
Timeframe: Day 0 to Day 84

Percent Change in Forced Expiratory Volume in 1 Second (FEV1) (L)

Intervention	Days (Mean)
Placebo (Pooled BID/TID)	0.5
AZLI (Pooled BID/TID)	0.9

"Spirometry was performed at each visit. FEV1 was recorded according to American Thoracic Society (ATS) guidelines.~FEV1(L) is the measurement of the volume of air (expressed in liters) exhaled in 1 second.~The percent change in this parameter from Day 0 to Day 28 was determined for each treatment group." (NCT00104520)
Timeframe: Day 0 to Day 28

Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics

Intervention	Percent change in FEV1 (L) (Least Squares Mean)
Placebo (Pooled BID/TID)	-2.363
AZLI (Pooled BID/TID)	3.917

The primary endpoint was time to need for a course of inhaled or IV antipseudomonal antibiotics with documented physician assessment of need for antibiotics. Antipseudomonal Antibiotic need was documented based on the presence of at least one of the following four symptoms predictive of pulmonary exacerbation: decreased exercise tolerance, increased cough, increased sputum / chest congestion, decreased appetite, or other. (NCT00104520)
Timeframe: Day 0 to Day 84 (end of study)

Minimum Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)

Intervention	Days (Median)
Placebo (Pooled BID/TID)	71
AZLI (Pooled BID/TID)	92

"The aztreonam susceptibility of PA isolates from sputum samples (collected at all visits) was assessed.~MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).~MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).~MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis." (NCT00104520)
Timeframe: Day 0 to Day 28

Number of Participants With Other Pathogens

Intervention	μg/mL (Number)
	Baseline MIC50	Day 28 MIC50	Baseline MIC90	Day 28 MIC90
AZLI (Pooled BID/TID)	2	4	32	64
Placebo (Pooled BID/TID)	1	1	64	64

"Sputum samples were collected at all visits for quantitative and qualitative culture for Staphylococcus aureus, Burkholderia cepacia, Stenotrophomonas maltophilia, and Achromobacter xylosoxidans.~Number of participants with other pathogens at baseline and at the end of treatment (28 days) are reported." (NCT00104520)
Timeframe: Day 0 and Day 28

Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum

Intervention	Participants (Number)
	S. aureus - Day 0	S. aureus - Day 28	B. cepacia - Day 0	B. cepacia - Day 28	S. maltophilia - Day 0	S. maltophilia - Day 28	A. xylosoxidans - Day 0	A. xylosoxidans - Day 28
AZLI (Pooled BID/TID)	58	63	0	0	18	19	10	7
Placebo (Pooled BID/TID)	23	23	0	0	9	8	6	6

Change in CFQ-R Respiratory Symptoms Scale (RSS) Score

Intervention	Log10 PA CFUs/gram of sputum (Least Squares Mean)
Placebo TID	0.069
75 mg AZLI TID	-1.384

The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R respiratory symptoms scale (RSS; range of scores: 0-100; higher scores indicate fewer symptoms). (NCT00112359)
Timeframe: Day 0 to Day 28

Change in CFQ-R RSS Score

Intervention	units on a scale (Least Squares Mean)
Placebo TID	-2.63
75 mg AZLI TID	7.08

The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms). (NCT00112359)
Timeframe: Day 0 to Day 14

Change in CFQ-R RSS Score

Intervention	units on a scale (Least Squares Mean)
Placebo TID	0.976
75 mg AZLI TID	7.007

Number of Participants Hospitalized at Least Once Between Day 0 and Day 42

Intervention	units on a scale (Least Squares Mean)
Placebo TID	-5.711
75 mg AZLI TID	0.618

Details of all hospitalizations, including the dates of admission and discharge, were recorded on the SAE eCRF. (NCT00112359)
Timeframe: Day 0 to Day 42

Number of Participants Receiving Intravenous (IV) or Inhaled Antipseudomonal Antibiotics Other Than Trial Drug

Intervention	participants (Number)
Placebo TID	12
75 mg AZLI TID	4

Use of IV and inhaled antipseudomonal antibiotics was compiled from data recorded on the Concomitant Medications eCRF. (NCT00112359)
Timeframe: Day 0 to Day 42

Percent Change in FEV1 (L)

Intervention	participants (Number)
Placebo TID	19
75 mg AZLI TID	12

Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. The percent change from baseline in forced expiratory volume (liters) in one second (FEV1) was determined at Day 28. (NCT00112359)
Timeframe: Day 0 to Day 28

Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)

Intervention	Percent change in FEV1 (L) (Least Squares Mean)
Placebo TID	-2.408
75 mg AZLI TID	7.886

"PA isolates from sputum samples (collected at all visits) were assessed for their susceptibility to aztreonam.~MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).~MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).~MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis." (NCT00112359)
Timeframe: Day 0

Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)

Intervention	μg/mL (Number)
	Day 0 MIC50	Day 0 MIC90
75 mg AZLI TID	4	128
Placebo TID	2	64

Number of Participants With Other Pathogens Present

Intervention	μg/mL (Number)
	Day 28 MIC50	Day 28 MIC90
75 mg AZLI TID	8	128
Placebo TID	2	64

Sputum samples were collected at all visits for quantitative and qualitative culture for Staphylococcus aureus, Burkholderia cepacia, Stenotrophomonas maltophilia, Achromobacter xylosoxidans. (NCT00112359)
Timeframe: Day 0 to Day 28

Change From Baseline in CFQ-R Physical Functioning Domain Score

Intervention	participants (Number)
	Staphylococcus aureus - Day 0	Staphylococcus aureus - Day 28	Burkholderia cepacia - Day 0	Burkholderia cepacia - Day 28	Stenotrophomonas maltophilia - Day 0	Stenotrophomonas maltophilia - Day 28	Achromobacter xylosoxidans - Day 0	Achromobacter xylosoxidans - Day 28
75 mg AZLI TID	37	35	1	0	1	2	1	1
Placebo TID	30	31	0	0	4	2	5	7

The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0 (baseline), 14, 28, and 42 (the last study visit). The endpoint was change from baseline in the physical functioning domain (e.g., ability to walk and engage in physical activities) of the CFQ-R at Day 28 (range of scores: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R physical functioning domain score and age group (<18 vs. >=18 years) were included as covariates in the analysis. (NCT00712166)
Timeframe: Day 0 to Day 28

Change From Baseline in CFQ-R RSS Score at Day 14

Intervention	Units on a scale (Least Squares Mean)
Placebo Three Times Daily (TID)	-0.69
AZLI 75 mg Three Times Daily (TID)	1.79

The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis. (NCT00712166)
Timeframe: Day 0 to Day 14

Change From Baseline in CFQ-R RSS Score at Day 42

Intervention	Units on a scale (Least Squares Mean)
Placebo Three Times Daily (TID)	0.28
AZLI 75 mg Three Times Daily (TID)	3.65

Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28

Intervention	Units on a scale (Least Squares Mean)
Placebo Three Times Daily (TID)	2.91
AZLI 75 mg Three Times Daily (TID)	3.02

Change From Baseline in Log10 Pseudomonas Aeruginosa (PA) Colony Forming Units (CFUs) in Sputum at Day 28

Sputum samples were collected at all study visits for quantitative and qualitative culture for PA. Sputum PA density was quantified by logarithm transformation of the CFU value with base 10. Change from baseline in sputum PA density was calculated as the difference between the log10 CFU values at Day 28 (Visit 4) and the baseline value. Missing data was not imputed. Baseline log10 CFU and age group (<18 vs. >=18 years) were included as covariates in the analysis. (NCT00712166)
Timeframe: Day 0 to Day 28

Number of Participants Hospitalized During Study

Hospitalization was defined as any hospital admission lasting for more than 1 calendar day that had been recorded as a serious adverse event (SAE) on the electronic case report form (eCRF). Binary variables were defined to indicate whether participants experienced any hospitalization. Number of hospitalizations was summarized by treatment group. (NCT00712166)
Timeframe: Day 0 to Day 42

Number of Participants Using Additional (Nonprotocol-specified) Antipseudomonal Antibiotics During Study

The number of participants requiring additional antipseudomonal antibiotics (oral, intravenous [IV], or by inhalation), the time to use of these antibiotics, and the reasons for use was recorded. A binary variable was defined to indicate whether the participants needed any antipseudomonal antibiotics that were non-study drug via the oral, IV, or inhalation route between Day 0 (Baseline Visit) and Day 42 (Visit 5). Fisher's Exact Test was implemented on the intent-to-treat (ITT) and per protocol analysis sets to detect treatment effects on need for additional antipseudomonal antibiotics. (NCT00712166)
Timeframe: Day 0 to Day 42

Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted

Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested by the ANCOVA model using the ITT analysis set. Baseline FEV1 percent predicted and age group (<18 vs. >=18 years) were included as covariates in the analysis. (NCT00712166)
Timeframe: Day 0 to Day 28

Number of Participants Testing Positive for Other Respiratory Pathogens

Sputum/throat swab samples were collected at all visits for quantitative and qualitative culture of Burkholderia species, Stenotrophomonas maltophilia, Achromobacter xylosidans, methicillin-resistant Staphylococcus aureus (MRSA), methicillin-sensitive S. aureus (MSSA), and Aspergillus species. One CFU on the culture from either a sputum or throat swab sample was considered presence of the particular organism. (NCT00712166)
Timeframe: Day 0 to Day 28

The Minimum Concentrations of Aztreonam That Inhibit 50% and 90% of All PA Isolates (MIC50 and MIC90, Respectively)

Aztreonam susceptibility of PA isolates from expectorated sputum samples (collected at all visits) was assessed. The minimum inhibitory concentration (MIC) is the lowest concentration of antimicrobial agent that inhibits visible growth of a microorganism. The MIC50 and MIC90 for PA is the MIC required to inhibit the growth of 50% or 90% of PA isolates, respectively. Given that there might be multiple PA isolates for each participant, the MIC50 and MIC90 for PA was calculated using the MIC values for all PA isolates. The MIC50 and MIC90 were calculated by treatment group. (NCT00712166)
Timeframe: Day 0 to Day 28

Actual Change From Baseline in CF Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28

The CFQ-R is a validated patient-reported outcome tool measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from baseline, assessed with the CFQ-R RSS (range of scores [units]: 0-100; higher scores indicate fewer symptoms). (NCT00757237)
Timeframe: Baseline and end of treatment Course 1 (Day 28)

Mean Actual Change From Baseline in CFQ-R RSS Score Across 3 Treatment Courses

The CFQ-R is a validated patient-reported outcome tool measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The endpoint was the average actual change in respiratory symptoms (e.g., coughing, congestion, wheezing) from baseline, assessed with the CFQ-R RSS (range of scores [units]: 0-100; higher scores indicate fewer symptoms) at the end of each treatment course (Weeks 4, 12, and 20). (NCT00757237)
Timeframe: Baseline and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)

Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses

"Spirometry was performed according to ATS guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height.~Treatment effect on the average adjusted means for the actual change in FEV1 percent predicted at Visits 4, 6, and 8 (Weeks 4, 12, and 20) was tested by mixed-effect model repeated measures (MMRM) analysis using the ITT population analysis set." (NCT00757237)
Timeframe: Baseline, and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)

Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization

"Spirometry was performed according to ATS guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height.~Treatment effect on the average adjusted means for the actual change in FEV1 percent predicted at Visits 4, 6, and 8 (Weeks 4, 12, and 20) was tested by MMRM analysis using the population of participants with prior inhaled tobramycin use of >=84 days in the previous 12 months." (NCT00757237)
Timeframe: Baseline and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)

Number of Respiratory Events Requiring IV and/or Inhaled Antipseudomonal Antibiotics (Other Than Randomized Treatment)

Inhaled and/or IV antipseudomonal antibiotic use for respiratory event was determined through event adjudication by a sponsor-independent, blinded review committee. Use of IV and/or inhaled antipseudomonal antibiotics was compiled from data recorded on the concomitant medications eCRF and compared to reported AEs to determine use for a respiratory event. The time to IV and/or inhaled antipseudomonal antibiotic use was measured in days from baseline (Visit 2) to the date of first antipseudomonal antibiotic use or the date of study completion (last visit)/or early withdrawal if censored. (NCT00757237)
Timeframe: Day 0 through Day 168 (end of study)

Relative Change From Baseline in FEV1 Percent Predicted at Day 28 in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization

Spirometry was performed according to ATS guidelines. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested using an ANCOVA model-based method, using the population of participants with prior inhaled tobramycin use of >= 84 days in the previous 12 months. (NCT00757237)
Timeframe: Baseline and end of treatment Course 1 (Day 28)

Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28

Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested using an analysis of covariance (ANCOVA) model-based method. (NCT00757237)
Timeframe: Baseline and end of treatment Course 1 (Day 28)

Time to First Respiratory Hospitalization

"This endpoint was determined through the adjudication of events by a sponsor-independent, blinded review committee. Committee members reviewed all hospitalizations and determined which were related to respiratory events.~Details of all hospitalizations, including the dates of admission and discharge, were recorded on the serious adverse event (SAE) eCRF.~Time to first respiratory hospitalization was the number of days from baseline (Visit 2) to the date of first respiratory hospitalization or the date of study completion (last visit) /or early withdrawal if censored." (NCT00757237)
Timeframe: Day 0 to Day 168 (end of study)

Time to Need for Inhaled and/or IV Antipseudomonal Antibiotics for Respiratory Event (Other Than Randomized Treatment)

"Antipseudomonal antibiotic use for respiratory event was determined through event adjudication by a sponsor-independent, blinded review committee.~Use of IV and/or inhaled antibiotics for a respiratory event was compiled from data recorded on the concomitant medications eCRF and compared to reported AEs to determine use for a respiratory event. The time to antibiotic use for a respiratory event was measured in days from baseline (Day 0) to the date of first antibiotic use for a respiratory event or the date of study completion (last visit)/or early withdrawal if censored." (NCT00757237)
Timeframe: Day 0 to Day 168 (end of study)

Time to Need for Intravenous (IV) Antipseudomonal Antibiotics for Respiratory Events

"IV antipseudomonal antibiotic use for a respiratory event was determined through the adjudication of events by a sponsor-independent, blinded review committee.~Use was compiled from data recorded on the concomitant medications electronic case report form (eCRF) and compared to reported adverse events (AEs) to determine use for a respiratory event. The time to IV antipseudomonal antibiotic use was measured in days from baseline (Visit 2) to the date of first IV antipseudomonal antibiotic use or the date of study completion (last visit)/or early withdrawal if censored." (NCT00757237)
Timeframe: Day 0 to Day 168 (end of study)

Total Number of Respiratory Hospitalizations

Respiratory hospitalizations were determined through the adjudication of events by a sponsor-independent, blinded review committee. Committee members reviewed hospitalizations and determined which were related to respiratory events. (NCT00757237)
Timeframe: Day 0 to Day 168 (end of study)

Treatment Satisfaction Questionnaire for Medication (TSQM) - Global Satisfaction Results at Week 20

This 14 item questionnaire consists of 3 subscales that gauge participant perceptions of a medication's effectiveness, side effects, and convenience. The measure also contains a global satisfaction scale to evaluate overall participant satisfaction. The global satisfaction score is the endpoint reported here. The range of scores is 0 to 100, with higher scores indicating greater satisfaction. (NCT00757237)
Timeframe: At Week 20

Intervention	Units on a scale (Least Squares Mean)
AZLI (75 mg TID)	8.20
TIS (300 mg BID)	2.59

Intervention	units on a scale (Least Squares Mean)
AZLI (75 mg TID)	6.30
TIS (300 mg BID)	2.17

Intervention	actual change in FEV1 percent predicted (Least Squares Mean)
AZLI (75 mg TID)	2.05
TIS (300 mg BID)	-0.66

Intervention	Units on a scale (Least Squares Mean)
Placebo Three Times Daily (TID)	1.41
AZLI 75 mg Three Times Daily (TID)	3.22

Intervention	Log10 PA CFUs/gram of sputum (Least Squares Mean)
Placebo Three Times Daily (TID)	-0.14
AZLI 75 mg Three Times Daily (TID)	-1.35

Intervention	Percent change from baseline (Least Squares Mean)
Placebo Three Times Daily (TID)	-2.45
AZLI 75 mg Three Times Daily (TID)	0.29

Article	Year
Management strategies for severe Pseudomonas aeruginosa infections. Current opinion in infectious diseases, 2023, Dec-01, Volume: 36, Issue:6 Topics: Anti-Bacterial Agents; Aztreonam; Humans; Pseudomonas Infections	2023
Inhaled antibiotics for the treatment of chronic bronchopulmonary Pseudomonas aeruginosa infection in cystic fibrosis: systematic review of randomised controlled trials. Expert opinion on pharmacotherapy, 2013, Volume: 14, Issue:9 Topics: Administration, Inhalation; Anti-Bacterial Agents; Aztreonam; Chronic Disease; Colistin; Cystic Fibr	2013
Inhaled aztreonam lysine: an evidence-based review. Expert opinion on pharmacotherapy, 2013, Volume: 14, Issue:15 Topics: Administration, Inhalation; Anti-Bacterial Agents; Aztreonam; Costs and Cost Analysis; Cystic Fibros	2013
Aerosolized antibiotics in cystic fibrosis: an update. Expert review of respiratory medicine, 2014, Volume: 8, Issue:3 Topics: Administration, Inhalation; Amikacin; Anti-Bacterial Agents; Aztreonam; Colistin; Cystic Fibrosis; E	2014
Evidence for the efficacy of aztreonam for inhalation solution in the management of Pseudomonas aeruginosa in patients with cystic fibrosis. Therapeutic advances in respiratory disease, 2015, Volume: 9, Issue:1 Topics: Administration, Inhalation; Anti-Bacterial Agents; Aztreonam; Cystic Fibrosis; Humans; Pseudomonas a	2015
Antibiotic therapy for stable non-CF bronchiectasis in adults - A systematic review. Chronic respiratory disease, 2017, Volume: 14, Issue:2 Topics: Aminoglycosides; Anti-Bacterial Agents; Aztreonam; Bronchiectasis; Ciprofloxacin; Colistin; Disease	2017
Update in cystic fibrosis 2009. American journal of respiratory and critical care medicine, 2010, Mar-15, Volume: 181, Issue:6 Topics: Adult; Anti-Bacterial Agents; Aztreonam; Child; Child, Preschool; Cystic Fibrosis; Genetic Predispos	2010
Optimal airway antimicrobial therapy for cystic fibrosis: the role of inhaled aztreonam lysine. Expert opinion on pharmacotherapy, 2010, Volume: 11, Issue:8 Topics: Administration, Inhalation; Aerosols; Anti-Bacterial Agents; Aztreonam; Controlled Clinical Trials a	2010
Aztreonam lysine: a novel inhalational antibiotic for cystic fibrosis. Expert review of respiratory medicine, 2010, Volume: 4, Issue:4 Topics: Administration, Inhalation; Adult; Aerosols; Anti-Bacterial Agents; Aztreonam; Cystic Fibrosis; Huma	2010
Aztreonam lysine for inhalation solution: in cystic fibrosis. Drugs, 2010, Oct-01, Volume: 70, Issue:14 Topics: Administration, Inhalation; Anti-Bacterial Agents; Aztreonam; Cystic Fibrosis; Humans; Lysine; Pharm	2010
Aztreonam inhalation solution for suppressive treatment of chronic Pseudomonas aeruginosa lung infection in cystic fibrosis. Expert review of anti-infective therapy, 2011, Volume: 9, Issue:11 Topics: Administration, Inhalation; Adolescent; Adult; Aerosols; Anti-Bacterial Agents; Aztreonam; Bacterial	2011
Aztreonam lysine for inhalation: new formulation of an old antibiotic. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 2012, Jan-15, Volume: 69, Issue:2 Topics: Administration, Inhalation; Age Factors; Anti-Bacterial Agents; Aztreonam; Cystic Fibrosis; Humans;	2012
A network meta-analysis of the efficacy of inhaled antibiotics for chronic Pseudomonas infections in cystic fibrosis. Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2012, Volume: 11, Issue:5 Topics: Administration, Inhalation; Adolescent; Adult; Anti-Bacterial Agents; Aztreonam; Bacterial Load; Bay	2012
Optimization of anti-pseudomonal antibiotics for cystic fibrosis pulmonary exacerbations: I. aztreonam and carbapenems. Pediatric pulmonology, 2012, Volume: 47, Issue:12 Topics: Anti-Bacterial Agents; Aztreonam; Carbapenems; Cystic Fibrosis; Disease Progression; Humans; Pseudom	2012
Mycotic aneurysm of the descending thoracic aorta caused by Pseudomonas aeruginosa in a solid organ transplant recipient: case report and review. Surgical infections, 2002,Spring, Volume: 3, Issue:1 Topics: Adult; Aneurysm, Infected; Aortic Aneurysm, Thoracic; Aztreonam; Blood Vessel Prosthesis Implantatio	2002
[Aztreonam]. Antibiotiki i khimioterapiia = Antibiotics and chemoterapy [sic], 1992, Volume: 37, Issue:8 Topics: Aztreonam; Drug Evaluation; Enterobacteriaceae; Enterobacteriaceae Infections; Humans; In Vitro Tech	1992
Clinical experience with aztreonam. The Pediatric infectious disease journal, 1989, Volume: 8, Issue:9 Suppl Topics: Aztreonam; Bacterial Infections; Cystic Fibrosis; Gram-Negative Bacteria; Humans; Pseudomonas Infect	1989
The use of aztreonam in the cystic fibrosis patient. The Pediatric infectious disease journal, 1989, Volume: 8, Issue:9 Suppl Topics: Aztreonam; Bacterial Infections; Cystic Fibrosis; Gram-Negative Bacteria; Humans; Pseudomonas Infect	1989

Article	Year
The clinical and microbiological utility of inhaled aztreonam lysine for the treatment of acute pulmonary exacerbations of cystic fibrosis: An open-label randomised crossover study (AZTEC-CF). Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2021, Volume: 20, Issue:6 Topics: Administration, Inhalation; Adult; Anti-Bacterial Agents; Aztreonam; Cross-Over Studies; Cystic Fibr	2021
Azithromycin may antagonize inhaled tobramycin when targeting Pseudomonas aeruginosa in cystic fibrosis. Annals of the American Thoracic Society, 2014, Volume: 11, Issue:3 Topics: Administration, Inhalation; Adolescent; Adult; Anti-Bacterial Agents; Azithromycin; Aztreonam; Cysti	2014
Open label study of inhaled aztreonam for Pseudomonas eradication in children with cystic fibrosis: The ALPINE study. Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2015, Volume: 14, Issue:1 Topics: Administration, Inhalation; Adolescent; Anti-Bacterial Agents; Aztreonam; Child; Child, Preschool; C	2015
Inhaled aztreonam lysine versus inhaled tobramycin in cystic fibrosis. An economic evaluation. Annals of the American Thoracic Society, 2015, Volume: 12, Issue:7 Topics: Administration, Inhalation; Adolescent; Adult; Anti-Bacterial Agents; Aztreonam; Chronic Disease; Co	2015
Continuous alternating inhaled antibiotics for chronic pseudomonal infection in cystic fibrosis. Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2016, Volume: 15, Issue:6 Topics: Administration, Inhalation; Adolescent; Adult; Anti-Bacterial Agents; Aztreonam; Chronic Disease; Cy	2016
Impact of azithromycin on the clinical and antimicrobial effectiveness of tobramycin in the treatment of cystic fibrosis. Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2017, Volume: 16, Issue:3 Topics: Anti-Bacterial Agents; Azithromycin; Aztreonam; Cystic Fibrosis; Drug Administration Routes; Drug In	2017
Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. American journal of respiratory and critical care medicine, 2008, Nov-01, Volume: 178, Issue:9 Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Bacterial Agents; Aztreonam; Child; Chroni	2008
Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. American journal of respiratory and critical care medicine, 2008, Nov-01, Volume: 178, Issue:9 Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Bacterial Agents; Aztreonam; Child; Chroni	2008
Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. American journal of respiratory and critical care medicine, 2008, Nov-01, Volume: 178, Issue:9 Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Bacterial Agents; Aztreonam; Child; Chroni	2008
Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. American journal of respiratory and critical care medicine, 2008, Nov-01, Volume: 178, Issue:9 Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Bacterial Agents; Aztreonam; Child; Chroni	2008
Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. American journal of respiratory and critical care medicine, 2008, Nov-01, Volume: 178, Issue:9 Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Bacterial Agents; Aztreonam; Child; Chroni	2008
Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. American journal of respiratory and critical care medicine, 2008, Nov-01, Volume: 178, Issue:9 Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Bacterial Agents; Aztreonam; Child; Chroni	2008
Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. American journal of respiratory and critical care medicine, 2008, Nov-01, Volume: 178, Issue:9 Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Bacterial Agents; Aztreonam; Child; Chroni	2008
Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. American journal of respiratory and critical care medicine, 2008, Nov-01, Volume: 178, Issue:9 Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Bacterial Agents; Aztreonam; Child; Chroni	2008
Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. American journal of respiratory and critical care medicine, 2008, Nov-01, Volume: 178, Issue:9 Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Bacterial Agents; Aztreonam; Child; Chroni	2008
Efficacy and safety of inhaled aztreonam lysine for airway pseudomonas in cystic fibrosis. Chest, 2009, Volume: 135, Issue:5 Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Bacterial Agents; Aztreonam; Child; Cystic	2009
An 18-month study of the safety and efficacy of repeated courses of inhaled aztreonam lysine in cystic fibrosis. Pediatric pulmonology, 2010, Volume: 45, Issue:11 Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Bacterial Agents; Aztreonam; Child; Chroni	2010
Aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis, mild lung impairment, and P. aeruginosa. Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2011, Volume: 10, Issue:4 Topics: Administration, Inhalation; Adolescent; Anti-Bacterial Agents; Aztreonam; Child; Cystic Fibrosis; Fe	2011
Pseudomonas aeruginosa antibiotic susceptibility during long-term use of aztreonam for inhalation solution (AZLI). The Journal of antimicrobial chemotherapy, 2011, Volume: 66, Issue:10 Topics: Administration, Inhalation; Adolescent; Adult; Anti-Bacterial Agents; Aztreonam; Cystic Fibrosis; Dr	2011
Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: a comparative efficacy trial. Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2013, Volume: 12, Issue:2 Topics: Administration, Inhalation; Adolescent; Adult; Anti-Bacterial Agents; Aztreonam; Child; Cystic Fibro	2013
Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: a comparative efficacy trial. Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2013, Volume: 12, Issue:2 Topics: Administration, Inhalation; Adolescent; Adult; Anti-Bacterial Agents; Aztreonam; Child; Cystic Fibro	2013
Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: a comparative efficacy trial. Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2013, Volume: 12, Issue:2 Topics: Administration, Inhalation; Adolescent; Adult; Anti-Bacterial Agents; Aztreonam; Child; Cystic Fibro	2013
Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: a comparative efficacy trial. Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2013, Volume: 12, Issue:2 Topics: Administration, Inhalation; Adolescent; Adult; Anti-Bacterial Agents; Aztreonam; Child; Cystic Fibro	2013
A phase 2 study of aztreonam lysine for inhalation to treat patients with cystic fibrosis and Pseudomonas aeruginosa infection. Pediatric pulmonology, 2008, Volume: 43, Issue:1 Topics: Administration, Inhalation; Adolescent; Adult; Anti-Bacterial Agents; Aztreonam; Cystic Fibrosis; Do	2008
Evaluation of aztreonam in the treatment of serious gram-negative infections in a university hospital in Saudi Arabia. Journal of chemotherapy (Florence, Italy), 1992, Volume: 4, Issue:3 Topics: Acinetobacter; Acinetobacter Infections; Adult; Aztreonam; Bacteremia; Citrobacter; Cross Infection;	1992
Antipseudomonal therapy in cystic fibrosis: aztreonam and amikacin versus ceftazidime and amikacin administered intravenously followed by oral ciprofloxacin. European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology, 1989, Volume: 8, Issue:10 Topics: Adolescent; Adult; Amikacin; Aztreonam; Ceftazidime; Child; Child, Preschool; Ciprofloxacin; Cystic	1989
Controlled trial of aztreonam vs. tobramycin and azlocillin for acute pulmonary exacerbations of cystic fibrosis. The Pediatric infectious disease journal, 1988, Volume: 7, Issue:3 Topics: Adolescent; Azlocillin; Aztreonam; Child; Cystic Fibrosis; Drug Therapy, Combination; Female; Humans	1988
[Efficacy evaluation of aztreonam for suppurative otitis media]. The Japanese journal of antibiotics, 1986, Volume: 39, Issue:1 Topics: Adult; Aged; Aztreonam; Bacteria; Clinical Trials as Topic; Female; Humans; Kinetics; Male; Middle A	1986

aztreonam and Pseudomonas Infections

Research Excerpts

Research

Studies (119)

Authors

Clinical Trials (11)

Trial Overview

Trial Outcomes

Percentage of Participants With PA-negative Cultures at All Time Points After Cessation of Active Treatment (Evaluable Analysis Set)

Percentage of Participants With PA-negative Cultures at All Time Points After Cessation of Active Treatment (Sensitivity Analysis Set)

Change From Baseline in Body Mass Index (BMI)

Change From Baseline in CFQ-R RSS Score

Change From Baseline in FEV1% Predicted

Change From Baseline in Height

Change From Baseline in Weight

Percentage of Participants With PA-negative Cultures

Pharmacokinetics (PK) Peak and Trough Plasma Concentrations of Aztreonam

Use of Additional (Non-study) Antipseudomonal Antibiotics

Average Actual Change From Baseline in FEV1 % Predicted Across All Courses of AZLI/Placebo Treatment (Weeks 4, 12 and 20)

Average Change From Baseline in the CFQ-R Respiratory Symptom Scale (RSS) Score Across All Courses of AZLI/Placebo Treatment (Weeks 4, 12 and 20)

Percentage of Participants Who Used Non-study IV or Inhaled Antibiotics for PDEs

Rate of Hospitalizations for a Respiratory Event

Rate of Protocol-defined Exacerbations (PDE) From Baseline Through Week 24

Time to First Protocol-defined Pulmonary Exacerbation

Bronchoalveolar Lavage Fluid (BALF) Neutrophilia After Treatment, When Performed as Part of Clinical Care (SOC).

Change in Pulmonary Function, as Measured by Serial Forced Expiratory Flow (FEF25-75) on Spirometry at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1

Change in Pulmonary Function, as Measured by Serial Forced Expiratory Flow (FEF25-75) on Spirometry at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 5.

Change in Pulmonary Function, as Measured by Serial Forced Expiratory Volume in 1 Second (FEV1) on Spirometry

Change in Pulmonary Function, as Measured by Serial Forced Expiratory Volume in 1 Second (FEV1) on Spirometry

Change in Respiratory-specific Health Related Quality of Life, Measured by Serially Self Administered St. George's Respiratory Questionnaire (SGRQ) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1

Change in Respiratory-specific Health Related Quality of Life, Measured by Serially Self Administered St. George's Respiratory Questionnaire (SGRQ) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 5.

Among Patients Colonized With Pseudomonas Aeruginosa, Change in Infection Burden as Measured by the Culture Final Report (0,1+, 2+, 3+, 4+) of in Pseudomonas Aeruginosa Sputum or Bronchoalveolar Fluid.

Change in Global Health Related Quality of Life, Measured by Serially Self-administered Short Form 36 Health Survey Questionnaire (SF-36) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1

Change in Global Health Related Quality of Life, Measured by Serially Self-administered Short Form 36 Health Survey Questionnaire (SF-36) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1 and Month 5.

Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum

Change in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score

Number of Hospitalization Days

Percent Change in Forced Expiratory Volume in 1 Second (FEV1) (L)

Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics

Minimum Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)

Number of Participants With Other Pathogens

Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum

Change in CFQ-R Respiratory Symptoms Scale (RSS) Score

Change in CFQ-R RSS Score

Change in CFQ-R RSS Score

Number of Participants Hospitalized at Least Once Between Day 0 and Day 42

Number of Participants Receiving Intravenous (IV) or Inhaled Antipseudomonal Antibiotics Other Than Trial Drug

Percent Change in FEV1 (L)

Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)

Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)

Number of Participants With Other Pathogens Present

Change From Baseline in CFQ-R Physical Functioning Domain Score

Change From Baseline in CFQ-R RSS Score at Day 14

Change From Baseline in CFQ-R RSS Score at Day 42

Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28

Change From Baseline in Log10 Pseudomonas Aeruginosa (PA) Colony Forming Units (CFUs) in Sputum at Day 28

Number of Participants Hospitalized During Study

Number of Participants Using Additional (Nonprotocol-specified) Antipseudomonal Antibiotics During Study

Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted

Number of Participants Testing Positive for Other Respiratory Pathogens

The Minimum Concentrations of Aztreonam That Inhibit 50% and 90% of All PA Isolates (MIC50 and MIC90, Respectively)

Actual Change From Baseline in CF Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28

Mean Actual Change From Baseline in CFQ-R RSS Score Across 3 Treatment Courses

Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses

Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization

Number of Respiratory Events Requiring IV and/or Inhaled Antipseudomonal Antibiotics (Other Than Randomized Treatment)

Relative Change From Baseline in FEV1 Percent Predicted at Day 28 in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization

Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28

Time to First Respiratory Hospitalization

Time to Need for Inhaled and/or IV Antipseudomonal Antibiotics for Respiratory Event (Other Than Randomized Treatment)

Time to Need for Intravenous (IV) Antipseudomonal Antibiotics for Respiratory Events

Total Number of Respiratory Hospitalizations

Treatment Satisfaction Questionnaire for Medication (TSQM) - Global Satisfaction Results at Week 20

Reviews

Trials

Other Studies