(9R)-9-chloro-11-17-dihydroxy-17-(2-hydroxy-1-oxoethyl)-10-13-16-trimethyl-6-7-8-11-12-14-15-16-octahydrocyclopenta[a]phenanthren-3-one and Respiratory-Tract-Infections

The goal of this study was to evaluate the effectiveness of nebulized beclomethasone in preventing the recurrence of viral wheezing.. The study was designed as a randomized, double-blind, placebo-controlled trial. Outpatient children aged 1 to 5 years with at least 1 episode of viral wheezing in the last 12 months, presenting to any of 40 Italian pediatricians for an upper respiratory tract infection, were randomly allocated to receive beclomethasone 400 μg or placebo twice daily for 10 days. Medications were administered through a nebulizer. A clinical evaluation was performed by the pediatrician at the start and end of the treatment period. A subjective evaluation of symptoms and efficacy of treatment was performed by the parents. The primary endpoint was the incidence of viral wheezing diagnosed by the pediatricians during the 10-day treatment period.. A total of 525 children were enrolled in the study, 521 of whom were visited at the end of the treatment period. Wheezing was diagnosed by the pediatricians in 47 children (9.0% [95% confidence interval: 6.7 to 11.3]), with no statistically significant differences between treatment groups (beclomethasone versus placebo relative risk: 0.61 [95% confidence interval: 0.35 to 1.08]).The treatment was considered helpful by 63% of parents (64% in the beclomethasone group vs 61% in the placebo group). In all, 46% of children still had infection symptoms at the end of the treatment period, with no differences between groups.. The findings from this study confirm that inhaled steroids are not effective in preventing recurrence of viral wheezing. Moreover, no benefits were found in reducing symptoms of respiratory tract infections.

Topics: Anti-Inflammatory Agents; Beclomethasone; Child, Preschool; Double-Blind Method; Female; Humans; Infant; Male; Nebulizers and Vaporizers; Respiratory Sounds; Respiratory Tract Infections; Treatment Outcome

Post-infectious persistent cough may be caused by an underlying inflammation in the airways. Due to its antiinflammatory properties, inhaled corticosteroids (ICS) may be a rational therapeutic approach to reduce cough symptoms. In this randomized, double-blind study, the efficacy of treatment with inhaled extra-fine HFA beclomethasone diproprionate (HFA-BDP) was compared with placebo in patients with post-infectious persistent cough. A total of 72 patients with persistent cough lasting at least 3 days (max. 14 days) following an acute respiratory tract infection were randomized to treatment with extra-fine HFA-BDP (400 microg twice daily for 7 days followed by 200 microg twice daily for 4 days) or placebo. The efficacy was measured by tussometry. The primary endpoint was defined as a reduction of frequency of cough epochs/h at the end of treatment (Day 11) in relation to the baseline level and in comparison to placebo, calculated as the area under the curve (AUC). The treatment with extra-fine HFA-BDP resulted in a greater reduction of cough frequency in patients with post-infectious persistent cough in comparison to placebo. The AUC from Day 1 to Day 11 for the frequency of cough epochs/h between 7:00 am and 11:00 pm was calculated as 605.8 for HFA-BDP and 847.9 for placebo, respectively (P<0.05). There is evidence that extra-fine HFA-BDP leads to a more rapid reduction of cough frequency at the beginning of treatment. A short-term treatment with extra-fine HFA-BDP could be an effective and well tolerated therapeutic option in the treatment of post-infectious persistent cough.

Topics: Acute Disease; Administration, Inhalation; Adrenal Cortex Hormones; Adult; Aerosol Propellants; Antitussive Agents; Beclomethasone; Chemistry, Pharmaceutical; Cough; Double-Blind Method; Drug Administration Schedule; Female; Germany; Humans; Hydrocarbons, Fluorinated; Male; Middle Aged; Patient Compliance; Powders; Respiratory Tract Infections; Treatment Outcome

To compare the systemic safety and efficacy of hydrofluoroalkane beclomethasone dipropionate (HFA-BDP) extra-fine aerosol 800 microg/day with chlorofluorocarbon (CFC)-BDP 1500 microg/day.. Six-month, randomized, parallel-group, double-blind, double-dummy study.. Patients (n=141) with moderate to severe asthma adequately controlled by CFC-BDP 1000 microg/day to 2000 microg/day.. Patients received CFC-BDP 1500 microg/day during a two-week run-in period and were then randomized to either HFA-BDP (n=70) or CFC-BDP (n=71).. Similar proportions of HFA-BDP and CFC-BDP patients had a 24 h urinary free cortisol values below the reference range at month 6 (15% versus 25%, P=0.35). Measures of adrenocorticotrophic hormone stimulation and morning plasma cortisol levels were also similar in each group. The frequency of skin bruising and oral candidiasis was low for both treatments. No change in intraocular pressure was reported for either treatment. Pulmonary function was similar in both groups; however, the onset of the first asthma exacerbation or increased asthma symptoms tended to be earlier for CFC-BDP than for HFA-BDP (P=0.076); 27% of CFC-BDP patients reported increased asthma symptoms, compared with 14% of HFA-BDP patients (P=0.095).. HFA-BDP 800 microg/day has a systemic adverse event profile comparable to that of CFC-BDP 1500 microg/day, and further control of asthma symptoms may be achieved after a switch from CFC-BDP 1500 microg/day to HFA-BDP 800 microg/day.

Topics: Administration, Inhalation; Adolescent; Adult; Aerosol Propellants; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Chlorofluorocarbons; Double-Blind Method; Drug Administration Schedule; Female; Headache; Humans; Hydrocarbons, Fluorinated; Hydrocortisone; Male; Respiratory Tract Infections; Treatment Outcome

In school children with atopic asthma the beneficial effects of disodium cromoglycate (DSCG) and beclomethasone dipropionate (BDP) are well-established. In preschool children, wheezing is quite common, and in the majority of cases the symptoms are episodic and reported to be associated with viral infections rather than atopy. We compared the efficacy of regular treatment with DSCG and BDP for prevention of wheezing in preschool children. We were interested to establish whether regular treatment with inhaled anti-inflammatory drugs could lead to a decrease in bronchial responsiveness. In 15 patients (median age, 56 months; range, 43-66 months) bronchial responsiveness was assessed by measuring specific airway resistance (sRaw) during a histamine provocation test. The concentration of histamine eliciting a 100% increase in sRaw (PC100his) was determined. In a double-blind crossover study, patients inhaled either DSCG 10 mg three times a day or BDP 100 microg three times a day for 2 months. After a wash-out period, treatment was changed to BDP or DSCG, respectively. Daily peak flow measurements were carried out, and exacerbations were noted. PC100his was measured at the start and end of each treatment period. No significant decrease in bronchial responsiveness was seen (PC100his DSCG: before 1.3, after 1.66 mg/ml, Pvalue not significant; BDP: before 1.1 after 1.22 mg/ml, Pvalue not significant). Significantly higher morning peak flows were observed on BDP therapy (160 on BDP vs. 150 L/min on DSCG, P < 0.03). BDP treatment resulted in significantly fewer wheezing exacerbations (7 vs. 16, P < 0.005) compared with DSCG therapy. We conclude that in preschool children with episodic virally induced wheezing, BDP therapy was superior to DSCG aerosol treatments for the prevention of exacerbations of wheezing, although no significant effect on bronchial responsiveness was noted during either treatment protocol.

Topics: Administration, Inhalation; Airway Resistance; Anti-Asthmatic Agents; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Chi-Square Distribution; Child, Preschool; Cromolyn Sodium; Cross-Over Studies; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male; Peak Expiratory Flow Rate; Respiratory Sounds; Respiratory Tract Infections; Statistics, Nonparametric; Virus Diseases

To determine the effect of regular prophylactic inhaled corticosteroids on wheezing episodes associated with viral infection in school age children.. Randomised, double blind, placebo controlled trial.. Community based study in Southampton.. 104 children aged 7 to 9 years who had had wheezing in association with symptoms of upper and lower respiratory tract infection in the preceding 12 months.. After a run in period of 2-6 weeks children were randomly allocated twice daily inhaled beclomethasone dipropionate 200 micrograms or placebo through a Diskhaler for 6 months with a wash out period of 2 months. Children were assessed monthly.. Forced expiratory volume in 1 second (FEV1); bronchial responsiveness to methacholine (PD20); percentage of days with symptoms of upper and lower respiratory tract infection with frequency, severity, and duration of episodes of upper and lower respiratory symptoms and of reduced peak expiratory flow rate.. During the treatment period there was a significant increase in mean FEV1 (1.63 v 1.53 1; adjusted difference 0.09 1 (95% confidence interval 0.04 to 0.14); P = 0.001) and methacholine PD20 12.8 v 7.2 mumol/l; adjusted ratio of means 1.7 (1.2 to 2.4); P = 0.007) in children receiving beclomethasone dipropionate compared with placebo. There were, however, no significant differences in the percentage of days with symptoms or in the frequency, severity, or duration of episodes of upper or lower respiratory symptoms or of reduced peak expiratory flow rate during the treatment period between the two groups.. Although lung function is improved with regular beclomethasone dipropionate 400 micrograms/day, this treatment offers no clinically significant benefit in school age children with wheezing episodes associated with viral infection.

Topics: Administration, Inhalation; Anti-Asthmatic Agents; Beclomethasone; Child; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male; Methacholine Chloride; Nebulizers and Vaporizers; Peak Expiratory Flow Rate; Respiratory Sounds; Respiratory Tract Infections; Virus Diseases

Aerosolized steroids may be implicated in the increased incidence of chest infections. To evaluate such a possibility, we utilized a double-blind study to investigate the acute effect of inhaled beclomethasone dipropionate on mucociliary clearance in 10 patients with chronic obstructive lung disease (5 receiving the drug and 5 placebo). Mucociliary clearance was measured by inhalation of a 99mTc-labelled albumin aerosol. The resulting radioactivity was recorded externally by a large-field gamma camera and dedicated computer for 3 consecutive hours without patient repositioning. After 1-hour baseline recording, the subjects inhaled from a commercial pressurized canister either beclomethasone dipropionate (250 micrograms) or vehicle alone. The recording was then continued for 2 more hours. No statistically significant difference was found in clearance rates throughout the entire period of observation between patients receiving beclomethasone and controls. The data suggest that mechanisms other than mucociliary function impairment are responsible for the increased incidence of chest infections which may accompany steroid treatment by the inhalatory route.

Topics: Adult; Aerosols; Aged; Beclomethasone; Bronchitis; Cilia; Female; Humans; Lung; Male; Middle Aged; Mucus; Respiratory Tract Infections

100 patients with acute tracheitis, tracheobronchitis or bronchitis were randomly allocated to receive inhaled beclomethasone dipropionate (BDP) 100 micrograms qds or placebo as an adjunct to oral antihistamine and a tetracycline antibiotic. 2 patients were withdrawn from analysis, leaving 49 patients in each group. There was no evidence that inhaled BDP conferred any benefit or detriment on the progress of the condition as assessed by daily symptom scores and weekly clinic visits for up to 2 weeks. The same conclusion maintains when the patients were subdivided into two grades of severity as assessed by the physician when the patient first presented. Inhaled BDP would seem to have no role in the inflammatory process associated with those acute infections of presumed viral origins.

Topics: Acute Disease; Adult; Aerosols; Beclomethasone; Blood Sedimentation; Female; Humans; Leukocyte Count; Male; Middle Aged; Peak Expiratory Flow Rate; Radiography, Thoracic; Respiratory Tract Infections

Topics: Adrenal Cortex Hormones; Aerosols; Asthma; Beclomethasone; Candidiasis; Candidiasis, Oral; Dose-Response Relationship, Drug; Female; Humans; Male; Middle Aged; Nystatin; Respiratory Tract Infections; Time Factors; Voice Disorders

Topics: Administration, Oral; Administration, Topical; Adrenal Insufficiency; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Clinical Trials as Topic; Glucocorticoids; Humans; Pharyngitis; Placebos; Prednisone; Respiratory Function Tests; Respiratory Tract Infections; Rhinitis, Allergic, Seasonal; Substance Withdrawal Syndrome; Substance-Related Disorders

To investigate if high dose inhaled beclomethasone dipropionate started early after upper respiratory tract infection (URTI) could reduce recurrent wheezing in infants.. Twenty-six ambulatory infants, 7-12 months of age, with recurrent wheezing during upper respiratory tract infection participated. All experienced at least three wheezing attacks. Those with underlying lung or systemic disease were excluded. Infants were divided into two groups in an open unblinded manner, until 13 patients had been recruited for each group. The groups were similar in risk factors for recurrent wheezing. Four treatment periods of 5 days were planned for group 1. The dose regimen was nebulized beclomethasone 400 mg by mask tid for 5 days. Treatment was started at the very first sign of URTI prior to any sign of wheezing. Group 2 did not receive any preventive treatment and constituted the control group. Symptoms scores were recorded. The number of emergency room visits, hospital admissions and short courses with oral steroids was also noted.. Twelve infants completed 48 treatment periods. Five visited the emergency room, only one during beclomethasone therapy. Six received oral steroids, two receiving beclomethasone. No patient was admitted to the hospital. Symptom scores were significantly lower during beclomethasone treatment (p<0.05). No apparent adverse events were reported.. The infant with recurrent wheezing during URTI is a therapeutic challenge. Most of these infants have prodromal symptoms for about 24 hours before wheezing starts. In the present study we observed favorable results, decrease in the number the child wheezed and the number of acute attacks, when high dose inhaled beclomethasone is administered during this critical time.

Topics: Administration, Inhalation; Anti-Asthmatic Agents; Beclomethasone; Child; Drug Administration Schedule; Female; Humans; Male; Recurrence; Respiratory Sounds; Respiratory Tract Infections

The aim of this clinical study was to investigate the influence of beclomethasone dipropionate (BDP) inhalation therapy on respiratory bacterial infections in patients with acute exacerbation of chronic obstructive pulmonary disease (COPD). We studied 30 patients who had been admitted twice, (before and after the beginning BDP inhalation therapy) to our hospital because of an exacerbation of COPD by respiratory tract infection. No differences were observed before and after BDP inhalation therapy in values for PaO2, PaCO2, body temperature, CRP, WBC count, number of admission days, and bacterial culture of sputum on admission. These results suggest that BDP inhalation therapy has little influence on respiratory bacterial infection during exacerbation of COPD.

Topics: Administration, Inhalation; Aged; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Bacterial Infections; Beclomethasone; Female; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Respiratory Tract Infections; Retrospective Studies

Topics: Administration, Inhalation; Asthma; Beclomethasone; Haemophilus influenzae; Humans; Immunocompromised Host; Respiratory Tract Infections; Staphylococcus aureus; Streptococcus pneumoniae

The aim of this clinical study was to investigate the influence of beclomethasone dipropionate (BDP) inhalation therapy on respiratory bacterial infection in patient with an asthmatic attack. We studied 267 asthmatic attack episodes of 241 patients with/without BDP inhalation therapy. There was no difference between two groups in %peak flow, body temperature, CRP, WBC count, bacterial culture of sputum on admission. BDP inhalation therapy has little influence on respiratory bacterial infection at an asthmatic attack.

Topics: Adult; Anti-Asthmatic Agents; Asthma; Bacterial Infections; Beclomethasone; Female; Humans; Male; Respiratory Tract Infections

Systemic administration of corticosteroids was attempted in the treatment of olfactory loss resistant to topical corticosteroid treatment in patients with nasal and paranasal disease and post-upper respiratory infection. Significant efficacy was achieved with a short course of high-dose oral corticosteroids in patients with non-allergic sinus disease. On the other hand, anosmia induced by upper respiratory infection failed to respond to systemic corticosteroid treatment, suggesting permanent damage to the olfactory receptor cell. The underlying mechanism of effectiveness observed in patients with sinus disease may be explained by improvement of the mucosal thickening of the olfactory fissure, leading to the access of an odorant to the olfactory neuroepithelium.

Topics: Administration, Intranasal; Adult; Anti-Inflammatory Agents; Beclomethasone; Chronic Disease; Female; Glucocorticoids; Humans; Male; Middle Aged; Nose Diseases; Olfaction Disorders; Prednisolone; Respiratory Tract Infections; Sinusitis; Treatment Failure

Nasal polyposis is a recurrent disorder requiring numerous surgical polypectomies. Topical nasal steroidal inhalers such as beclomethasone dipropionate (BDP) and flunisolide nasal solution have greatly changed the therapeutic strategy for controlling polypoid formation in the nasal cavities. The judicious use of short courses of oral corticosteroids combined with oral nasal decongestants lessens the need for repeated polypectomies. Nasal douching with normal saline improves nasal ventilation.

Topics: Administration, Intranasal; Administration, Oral; Adolescent; Adrenal Cortex Hormones; Adult; Anti-Inflammatory Agents; Beclomethasone; Child; Female; Fluocinolone Acetonide; Glucocorticoids; Humans; Male; Nasal Decongestants; Nasal Polyps; Respiratory Hypersensitivity; Respiratory Tract Infections; Therapeutic Irrigation

The authors followed the development of serum precipitins to aspergillus and Candida albicans in 14 asthmatic patients placed on beclomethasone dipropionate inhalation at a mean duration of five months. Three sera positive for aspergillus precipitins became negative during treatment. One patient had clinical oropharyngeal candidiasis and another patient's serum became positive for candida precipitin. The authors conclude that the incidence of oropharyngeal candidiasis and candida or aspergillus precipitins are rare among patients treated with beclomethasone.

Topics: Adult; Aerosols; Aged; Antibodies, Fungal; Aspergillus; Asthma; Beclomethasone; Candida albicans; Female; Humans; Male; Middle Aged; Mycoses; Precipitins; Respiratory Tract Infections; Time Factors

Topics: Animals; Anti-Bacterial Agents; Anti-Infective Agents; Antifungal Agents; Beclomethasone; Candida albicans; Guinea Pigs; Macrophages; Pulmonary Alveoli; Respiratory Tract Infections; Staphylococcus aureus

A prospective study of forty adult asthmatic patients attending two chest clinics in the City of Liverpool was undertaken. All patients had reversible airways obstruction and were under treatment with either beclomethasone dipropionate or sodium cromoglycate. Satisfactory symptomatic control was achieved in both groups of patients on a subjective basis, but there was a statistically significant (P less than 0-001) reduction in the number of admissions to hospital in the treatment year compared to the preceding 12 months in the beclomethasone aerosol group. No increased incidence of lower respiratory tract infections or non-specific sore throats was found in either group studied. No cases of clinical oral Candida infection occurred in the beclomethasone aerosol treated patients. It is concluded that beclomethasone dipropionate in aerosol form is not only a safe and effective method for symptomatic control of adult bronchial asthma but is also economically worthwhile as a means of reducing hospital admissions in this vulnerable group of patients.

Topics: Adult; Aerosols; Asthma; Beclomethasone; Candidiasis, Oral; Cromolyn Sodium; Female; Hospitalization; Humans; Lung Diseases; Male; Middle Aged; Pharyngitis; Prospective Studies; Respiratory Tract Infections

Topics: Adolescent; Adrenal Cortex Hormones; Anti-Bacterial Agents; Asthma; Beclomethasone; Child; Child, Preschool; Cosyntropin; Drug Tolerance; Female; Humans; Hydrocortisone; Male; Respiratory Tract Infections; Time Factors

Topics: Adolescent; Adrenal Cortex Hormones; Adult; Aged; Airway Obstruction; Aspergillosis; Beclomethasone; Bronchodilator Agents; Female; Humans; Male; Methylprednisolone; Middle Aged; Respiratory Function Tests; Respiratory Tract Infections