Azithromycin for Acute Exacerbations of Asthma : The AZALEA Randomized Clinical Trial
| Autor: | Ernie Wong, Adel H. Mansur, Laura Robison, Patrick Mallia, Deborah Ashby, P. W. Ind, David A. Jackson, Anoop Chauhan, Azalea, Trial, Team, Christopher Corrigan, Dave Singh, Mary Cross, Zahid Sattar, Neil C. Thomson, Matyas Szigeti, Bernard Higgins, Sebastian L. Johnston, Rekha Chaudhuri, Tim Harrison, Christopher E. Brightling |
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| Přispěvatelé: | National Institute for Health Research, NHIR, Medical Research Council (MRC), Asthma UK |
| Rok vydání: | 2016 |
| Předmět: |
Male
Pediatrics Emergency Medical Services Exacerbation Placebo-controlled study CHILDREN MYCOPLASMA-PNEUMONIAE HAEMOPHILUS-INFLUENZAE Azithromycin PLACEBO-CONTROLLED TRIAL law.invention DOUBLE-BLIND 0302 clinical medicine Randomized controlled trial law AZALEA Trial Team 030212 general & internal medicine education.field_of_study Bacterial Infections Middle Aged 1113 Opthalmology and Optometry 3. Good health Anti-Bacterial Agents Treatment Outcome Disease Progression Female Life Sciences & Biomedicine medicine.drug Adult medicine.medical_specialty Adolescent IN-VITRO ACTIVITY Population Placebo 1117 Public Health and Health Services 03 medical and health sciences Medicine General & Internal Double-Blind Method General & Internal Medicine BRONCHIAL EPITHELIAL-CELLS Internal Medicine medicine Humans VIRUS-INDUCED ASTHMA education INVASIVE PNEUMOCOCCAL DISEASE Asthma Science & Technology business.industry TELITHROMYCIN 1103 Clinical Sciences medicine.disease United Kingdom Clinical trial 030228 respiratory system Quality of Life business |
| Zdroj: | Johnston, S L, Szigeti, M, Cross, M, Brightling, C, Chaudhuri, R, Harrison, T, Mansur, A, Robison, L, Sattar, Z, Jackson, D, Mallia, P, Wong, E, Corrigan, C, Higgins, B, Ind, P, Singh, D, Thomson, N C, Ashby, D, Chauhan, A & AZALEA Trial Team 2016, ' Azithromycin for Acute Exacerbations of Asthma : The AZALEA Randomized Clinical Trial ', JAMA Internal Medicine, vol. 176, no. 11, pp. 1630-1637 . https://doi.org/10.1001/jamainternmed.2016.5664 Johnston, S L, Szigeti, M, Cross, M, Brightling, C, Chaudhuri, R, Harrison, T, Mansur, A, Robison, L, Sattar, Z, Jackson, D, Mallia, P, Wong, E, Corrigan, C, Higgins, B, Ind, P, Singh, D, Thomson, N C, Ashby, D & Chauhan, A 2016, ' Azithromycin for acute exacerbations of asthma : The AZALEA randomized clinical trial ', JAMA Internal Medicine, vol. 176, no. 11, pp. 1630-1637 . https://doi.org/10.1001/jamainternmed.2016.5664 |
| ISSN: | 2168-6114 |
| Popis: | Importance: Guidelines recommend against antibiotic use to treat asthma attacks. A study with telithromycin reported benefit, but adverse reactions limit its use.Objective: To determine whether azithromycin added to standard care for asthma attacks in adults results in clinical benefit.Design, Setting, and Participants: The Azithromycin Against Placebo in Exacerbations of Asthma (AZALEA) randomized, double-blind, placebo-controlled clinical trial, a United Kingdom-based multicenter study in adults requesting emergency care for acute asthma exacerbations, ran from September 2011 to April 2014. Adults with a history of asthma for more than 6 months were recruited within 48 hours of presentation to medical care with an acute deterioration in asthma control requiring a course of oral and/or systemic corticosteroids.Interventions: Azithromycin 500 mg daily or matched placebo for 3 days.Main Outcomes and Measures: The primary outcome was diary card symptom score 10 days after randomization, with a hypothesized treatment effect size of -0.3. Secondary outcomes were diary card symptom score, quality-of-life questionnaires, and lung function changes, all between exacerbation and day 10, and time to a 50% reduction in symptom score.Results: Of 4582 patients screened at 31 centers, 199 of a planned 380 were randomized within 48 hours of presentation. The major reason for nonrecruitment was receipt of antibiotics (2044 [44.6%] screened patients). Median time from presentation to drug administration was 22 hours (interquartile range, 14-28 hours). Exacerbation characteristics were well balanced across treatment arms and centers. The primary outcome asthma symptom scores were mean (SD), 4.14 (1.38) at exacerbation and 2.09 (1.71) at 10 days for the azithromycin group and 4.18 (1.48) and 2.20 (1.51) for the placebo group, respectively. Using multilevel modeling, there was no significant difference in symptom scores between azithromycin and placebo at day 10 (difference, -0.166; 95% CI, -0.670 to 0.337), nor on any day between exacerbation and day 10. No significant between-group differences were observed in quality-of-life questionnaires or lung function between exacerbation and day 10, or in time to 50% reduction in symptom score.Conclusions and Relevance: In this randomized population, azithromycin treatment resulted in no statistically or clinically significant benefit. For each patient randomized, more than 10 were excluded because they had already received antibiotics.Trial Registration: clinicaltrials.gov Identifier: NCT01444469. |
| Databáze: | OpenAIRE |
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