Azithromycin for Acute Exacerbations of Asthma: the AZALEA randomized clinical trial
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, SET...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
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American Medical Association
2016
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| Online Access: | https://eprints.nottingham.ac.uk/38491/ |
| _version_ | 1848795623494516736 |
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| author | Johnson, Sebastian L. Szigeti, Matyas Cross, Mary Brightling, Christopher Chaudhuri, R. Harrison, Timothy W. Mansur, Adel Robison, Laura Sattar, Zahid Jackson, David Mallia, Patrick Wong, Ernie Corrigan, Christopher Higgins, Bernhard Ind, Philip Singh, Dave Thomson, Neil C. Ashby, Deborah Chauhan, Anoop |
| author_facet | Johnson, Sebastian L. Szigeti, Matyas Cross, Mary Brightling, Christopher Chaudhuri, R. Harrison, Timothy W. Mansur, Adel Robison, Laura Sattar, Zahid Jackson, David Mallia, Patrick Wong, Ernie Corrigan, Christopher Higgins, Bernhard Ind, Philip Singh, Dave Thomson, Neil C. Ashby, Deborah Chauhan, Anoop |
| author_sort | Johnson, Sebastian L. |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | 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 500mg 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 |
| first_indexed | 2025-11-14T19:35:02Z |
| format | Article |
| id | nottingham-38491 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T19:35:02Z |
| publishDate | 2016 |
| publisher | American Medical Association |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-384912020-05-04T18:19:23Z https://eprints.nottingham.ac.uk/38491/ Azithromycin for Acute Exacerbations of Asthma: the AZALEA randomized clinical trial Johnson, Sebastian L. Szigeti, Matyas Cross, Mary Brightling, Christopher Chaudhuri, R. Harrison, Timothy W. Mansur, Adel Robison, Laura Sattar, Zahid Jackson, David Mallia, Patrick Wong, Ernie Corrigan, Christopher Higgins, Bernhard Ind, Philip Singh, Dave Thomson, Neil C. Ashby, Deborah Chauhan, Anoop 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 500mg 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 American Medical Association 2016-11-30 Article PeerReviewed Johnson, Sebastian L., Szigeti, Matyas, Cross, Mary, Brightling, Christopher, Chaudhuri, R., Harrison, Timothy W., Mansur, Adel, Robison, Laura, Sattar, Zahid, Jackson, David, Mallia, Patrick, Wong, Ernie, Corrigan, Christopher, Higgins, Bernhard, Ind, Philip, Singh, Dave, Thomson, Neil C., Ashby, Deborah and Chauhan, Anoop (2016) Azithromycin for Acute Exacerbations of Asthma: the AZALEA randomized clinical trial. JAMA Internal Medicine, 176 (11). pp. 1630-1637. ISSN 2168-6114 http://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2553295 doi:10.1001/jamainternmed.2016.5664 doi:10.1001/jamainternmed.2016.5664 |
| spellingShingle | Johnson, Sebastian L. Szigeti, Matyas Cross, Mary Brightling, Christopher Chaudhuri, R. Harrison, Timothy W. Mansur, Adel Robison, Laura Sattar, Zahid Jackson, David Mallia, Patrick Wong, Ernie Corrigan, Christopher Higgins, Bernhard Ind, Philip Singh, Dave Thomson, Neil C. Ashby, Deborah Chauhan, Anoop Azithromycin for Acute Exacerbations of Asthma: the AZALEA randomized clinical trial |
| title | Azithromycin for Acute Exacerbations of Asthma: the AZALEA randomized clinical trial |
| title_full | Azithromycin for Acute Exacerbations of Asthma: the AZALEA randomized clinical trial |
| title_fullStr | Azithromycin for Acute Exacerbations of Asthma: the AZALEA randomized clinical trial |
| title_full_unstemmed | Azithromycin for Acute Exacerbations of Asthma: the AZALEA randomized clinical trial |
| title_short | Azithromycin for Acute Exacerbations of Asthma: the AZALEA randomized clinical trial |
| title_sort | azithromycin for acute exacerbations of asthma: the azalea randomized clinical trial |
| url | https://eprints.nottingham.ac.uk/38491/ https://eprints.nottingham.ac.uk/38491/ https://eprints.nottingham.ac.uk/38491/ |