fluticasone and Headache

Adverse events (AEs) associated with short-term corticosteroid use for respiratory conditions in young children.. Systematic review of primary studies.. Medline, Cochrane CENTRAL, Embase and regulatory agencies were searched September 2014; search was updated in 2017.. Children <6 years with acute respiratory condition, given inhaled (high-dose) or systemic corticosteroids up to 14 days.. One reviewer extracted with another reviewer verifying data. Study selection and methodological quality (McHarm scale) involved duplicate independent reviews. We extracted AEs reported by study authors and used a categorisation model by organ systems. Meta-analyses used Peto ORs (pORs) and DerSimonian Laird inverse variance method utilising Mantel-Haenszel Q statistic, with 95% CI. Subgroup analyses were conducted for respiratory condition and dose.. Eighty-five studies (11 505 children) were included; 68 were randomised trials. Methodological quality was poor overall due to lack of assessment and inadequate reporting of AEs. Meta-analysis (six studies; n=1373) found fewer cases of vomiting comparing oral dexamethasone with prednisone (pOR 0.29, 95% CI 0.17 to 0.48; I. Evidence suggests that short-term high-dose inhaled or systemic corticosteroids use is not associated with an increase in AEs across organ systems. Uncertainties remain, particularly for recurrent use and growth outcomes, due to low study quality, poor reporting and imprecision.

Topics: Acute Disease; Administration, Inhalation; Administration, Intravenous; Administration, Oral; Adrenal Cortex Hormones; Asthma; Bronchiolitis, Viral; Child, Preschool; Croup; Dexamethasone; Fluticasone; Glucocorticoids; Growth Disorders; Headache; Humans; Infant; Injections, Intramuscular; Pneumonia; Prednisone; Respiratory Sounds; Respiratory Tract Diseases; Respiratory Tract Infections; Tremor; Vomiting

The systemic exposure of fluticasone propionate with hydrofluoroalkane propellant compared with chlorofluoro-carbon propellant and the effect of fluticasone propionate hydrofluoroalkane on 24-hour urinary cortisol in children aged 4 to 11 years with asthma were evaluated. Study 1 was an open-label, 2-way crossover study in which 16 subjects were randomized to 7.5 days each of fluticasone propionate hydrofluoroalkane 88 mug twice a day or fluticasone propionate chlorofluorocarbon 88 mug twice a day. In study 2, 63 subjects received 13.5 days of placebo followed by 27.5 days of fluticasone propionate hydrofluoroalkane 88 mug twice a day. The main outcome measure for study 1 was the difference between fluticasone propionate hydrofluoroalkane and fluticasone propionate chlorofluorocarbon in fluticasone propionate AUC(last) (area under the plasma fluticasone propionate concentration-time curve from zero up to the last quantifiable plasma concentration), and for study 2, 24-hour overnight urinary cortisol excretion. In study 1, fluticasone propionate systemic exposure was significantly lower (55%) with hydrofluoroalkane metered dose inhaler compared with chlorofluorocarbon metered dose inhaler. Study 2 showed no statistically significant changes in 24-hour overnight urinary cortisol excretion and no relationship to fluticasone propionate systemic exposure at this dose. The results of these 2 studies showed that in children aged 4 to 11 years with asthma, fluticasone propionate hydrofluoroalkane has lower systemic exposure compared with chlorofluorocarbon and no hypothalamic-pituitary-adrenal axis effects as measured by 24-hour urinary cortisol excretion.

Topics: Administration, Inhalation; Aerosol Propellants; Androstadienes; Anti-Asthmatic Agents; Area Under Curve; Asthma; Child; Child, Preschool; Chlorofluorocarbons; Cough; Cross-Over Studies; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Fever; Fluticasone; Half-Life; Headache; Humans; Hydrocarbons, Fluorinated; Hydrocortisone; Male; Metered Dose Inhalers; Nausea; Respiratory Tract Infections

To our knowledge, there are no published studies that evaluated the efficacy of azelastine hydrochloride nasal spray in combination with an intranasal corticosteroid, although anecdotal reports of the use of these agents in combination are common.. To determine if greater efficacy could be achieved with the intranasal antihistamine azelastine and the intranasal corticosteroid fluticasone propionate used concurrently compared with the efficacy of each agent alone.. This randomized, 2-week, multicenter, double-blind trial was conducted during the Texas mountain cedar season. After a 5-day placebo lead-in period, 151 patients with moderate to severe nasal symptoms were randomized to treatment with the following: (1) azelastine nasal spray, 2 sprays per nostril twice daily; (2) fluticasone nasal spray, 2 sprays per nostril once daily; or (3) azelastine nasal spray, 2 sprays per nostril twice daily, plus fluticasone nasal spray, 2 sprays per nostril once daily. The primary efficacy variable was the change from baseline in the total nasal symptom score (TNSS), consisting of sneezing, itchy nose, runny nose, and nasal congestion.. All 3 groups had statistically significant (P < .001) improvements from their baseline TNSS after 2 weeks of treatment. The TNSS improved 27.1% with fluticasone nasal spray, 24.8% with azelastine nasal spray, and 37.9% with the 2 agents in combination (P < .05 vs either agent alone). All 3 treatments were well tolerated.. The significant improvement in the TNSS with combination therapy relative to the individual agents alone is in contrast to previously published studies that found no advantage with an oral antihistamine and an intranasal corticosteroid in combination. Azelastine nasal spray and fluticasone nasal spray in combination may provide a substantial therapeutic benefit for patients with seasonal allergic rhinitis compared with therapy with either agent alone.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Androstadienes; Bronchodilator Agents; Child; Double-Blind Method; Drug Therapy, Combination; Female; Fluticasone; Headache; Humans; Male; Middle Aged; Phthalazines; Rhinitis, Allergic, Seasonal; Taste; Treatment Outcome

To compare the long-term effects of an inhaled corticosteroid with those of a leukotriene modifier on measures of clinical efficacy, subject preference, and safety in patients with persistent asthma.. Between November 17, 1998, and May 26, 2000, we conducted a multicenter, randomized, double-blind, double-dummy, parallel-group study of patients aged 15 years or older with persistent asthma. The patients were symptomatic while taking short-acting beta2-agonists alone and were treated with fluticasone propionate (88 microg [2 puffs of 44 microg] twice daily) or montelukast (10 mg/d) for 24 weeks. Measures of pulmonary function, asthma symptoms, albuterol use, nighttime awakenings, physician assessments of efficacy, patient satisfaction, asthma-related quality of life, and safety were evaluated.. A total of 522 patients were randomized to receive fluticasone or montelukast, and 395 patients completed the study. At end point, treatment with fluticasone significantly improved pulmonary function, asthma symptom scores, the percentage of symptom-free days, rescue albuterol use, and the number of nighttime awakenings due to asthma when compared with montelukast (P< or = .002, each comparison). Significantly more patients were satisfied with fluticasone therapy (83%) compared with montelukast therapy (66%) (P<.001), and fluticasone therapy was rated as effective by a significantly greater portion of physicians (67%) than was montelukast therapy (54%) (P<.001). Treatment with fluticasone significantly improved asthma-related quality-of-life measures compared with montelukast (P< or =.01). The incidence of asthma exacerbations was similar in the fluticasone (19 patients, 7%) and montelukast (21 patients, 8%) treatment groups, although slightly more patients in the montelukast group were withdrawn from the study because of asthma exacerbations (6% vs 4%, respectively).. Long-term treatment with a low dose of inhaled fluticasone is more effective than oral montelukast as first-line maintenance therapy for the treatment of persistent asthma.

Topics: Acetates; Administration, Inhalation; Administration, Oral; Adolescent; Adult; Aged; Androstadienes; Anti-Allergic Agents; Anti-Asthmatic Agents; Asthma; Bronchodilator Agents; Chronic Disease; Cyclopropanes; Dose-Response Relationship, Drug; Double-Blind Method; Female; Fluticasone; Headache; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Patient Satisfaction; Quality of Life; Quinolines; Respiratory Tract Infections; Sleep Initiation and Maintenance Disorders; Sulfides; Treatment Outcome

Fluticasone propionate (FP) is a topical corticosteroid with minimal systemic activity. We examined safety and compared the efficacy of FP aqueous nasal spray, 200 micrograms every day with loratadine tablets, 10 mg by mouth every day in 240 adolescents with ragweed pollen-induced seasonal allergic rhinitis for 4 weeks in a randomized, double-blind, parallel-group study. Nasal and eye symptoms were recorded daily on a 4-point (0 to 3) scale. A higher percentage of symptom-free days was observed for nasal blockage on waking during treatment with FP (p < 0.0001). Significant results were also obtained for all other nasal symptoms when analyzed for both symptom-free days and symptom scores. No differences were found for eye irritation symptoms (p = 0.14). Morning and evening nasal peak inspiratory flow (PIF) was recorded daily by 57 subjects. FP treatment was associated wit significantly higher PIF values than loratadine both morning (p = 0.0051) and evening (p = 0.0036). A greater improvement over 4 weeks was observed for PIF morning values in the FP group (p = 0.008) but not for evening values (p = 0.358). Statistically significant correlations were found for nasal blockage and PIF in the morning (r = -0.54, p = 0.0001) and in the evening (r = -0.46, p = 0.008).

Topics: Administration, Intranasal; Adolescent; Androstadienes; Anti-Allergic Agents; Child; Double-Blind Method; Female; Fluticasone; Headache; Humans; Loratadine; Male; Nose; Pharyngitis; Pulmonary Ventilation; Rhinitis, Allergic, Seasonal; Treatment Outcome

Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adrenal Insufficiency; Androstadienes; Cerebrospinal Fluid Pressure; Fluticasone; Headache; Humans; Hydrocortisone; Intracranial Hypertension; Magnetic Resonance Imaging; Male; Spinal Puncture; Tomography, X-Ray Computed

Aspergillus is a ubiquitous mold that can cause several types of symptomatic infections: allergic aspergillosis, typically in young atopic patients; aspergillomas (often referred to as fungus balls); and invasive aspergillosis, typically seen in debilitated or immunocompromised patients. We describe an 85-year-old woman who was not immunocompromised but had invasive aspergillosis of the paranasal sinus that resulted in unilateral headache and retrobulbar optic neuropathy. After extensive differential diagnostic examination, we concluded that the condition was possibly related to the long-term use of nasal corticosteroids (fluticasone propionate aqueous nasal spray). Surgical removal of solid masses of Aspergillus organisms followed by extended treatment with antifungal agents resulted in a favorable outcome.

Topics: Administration, Topical; Aged; Aged, 80 and over; Androstadienes; Anti-Inflammatory Agents; Aspergillosis; Female; Fluticasone; Glucocorticoids; Headache; Humans; Optic Nerve Diseases; Paranasal Sinus Diseases; Tomography, X-Ray Computed

Topics: Administration, Intranasal; Adolescent; Androstadienes; Anti-Inflammatory Agents; Back Pain; Fluticasone; Glucocorticoids; Headache; Humans; Intracranial Hypertension; Male; Rhinitis, Allergic, Seasonal