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Azithromycin for prevention of exacerbations in severe asthma (AZISAST): a multicentre randomised double-blind placebo-controlled trial

(2013) THORAX. 68(4). p.322-329
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Abstract
Background : Patients with severe asthma are at increased risk of exacerbations and lower respiratory tract infections (LRTI). Severe asthma is heterogeneous, encompassing eosinophilic and non-eosinophilic (mainly neutrophilic) phenotypes. Patients with neutropilic airway diseases may benefit from macrolides. Methods : We performed a randomised double-blind placebo-controlled trial in subjects with exacerbation-prone severe asthma. Subjects received low-dose azithromycin (n=55) or placebo (n=54) as add-on treatment to combination therapy of inhaled corticosteroids and long-acting beta(2) agonists for 6 months. The primary outcome was the rate of severe exacerbations and LRTI requiring treatment with antibiotics during the 26-week treatment phase. Secondary efficacy outcomes included lung function and scores on the Asthma Control Questionnaire (ACQ) and Asthma Quality of Life Questionnaire (AQLQ). Results : The rate of primary endpoints (PEPs) during 6 months was not significantly different between the two treatment groups: 0.75 PEPs (95% CI 0.55 to 1.01) per subject in the azithromycin group versus 0.81 PEPs (95% CI 0.61 to 1.09) in the placebo group (p=0.682). In a predefined subgroup analysis according to the inflammatory phenotype, azithromycin was associated with a significantly lower PEP rate than placebo in subjects with non-eosinophilic severe asthma (blood eosinophilia <= 200/mu l): 0.44 PEPs (95% CI 0.25 to 0.78) versus 1.03 PEPs (95% CI 0.72 to 1.48) (p=0.013). Azithromycin significantly improved the AQLQ score but there were no significant between-group differences in the ACQ score or lung function. Azithromycin was well tolerated, but was associated with increased oropharyngeal carriage of macrolide-resistant streptococci. Conclusions : Azithromycin did not reduce the rate of severe exacerbations and LRTI in patients with severe asthma. However, the significant reduction in the PEP rate in azithromycin-treated patients with non-eosinophilic severe asthma warrants further study.
Keywords
CLINICAL-PRACTICE, EOSINOPHILIC ASTHMA, CHLAMYDIA-PNEUMONIAE, OBSTRUCTIVE PULMONARY-DISEASE, CYSTIC-FIBROSIS, CLARITHROMYCIN, THERAPY, BRONCHIECTASIS, IDENTIFICATION, ROXITHROMYCIN

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MLA
Brusselle, Guy, Christine VanderStichele, Paul Jordens, et al. “Azithromycin for Prevention of Exacerbations in Severe Asthma (AZISAST): a Multicentre Randomised Double-blind Placebo-controlled Trial.” THORAX 68.4 (2013): 322–329. Print.
APA
Brusselle, G., VanderStichele, C., Jordens, P., Deman, R., Slabbynck, H., Ringoet, V., Verleden, G., et al. (2013). Azithromycin for prevention of exacerbations in severe asthma (AZISAST): a multicentre randomised double-blind placebo-controlled trial. THORAX, 68(4), 322–329.
Chicago author-date
Brusselle, Guy, Christine VanderStichele, Paul Jordens, René Deman, Hans Slabbynck, Veerle Ringoet, Geert Verleden, et al. 2013. “Azithromycin for Prevention of Exacerbations in Severe Asthma (AZISAST): a Multicentre Randomised Double-blind Placebo-controlled Trial.” Thorax 68 (4): 322–329.
Chicago author-date (all authors)
Brusselle, Guy, Christine VanderStichele, Paul Jordens, René Deman, Hans Slabbynck, Veerle Ringoet, Geert Verleden, Ingel K Demedts, Katia Verhamme, Anja Delporte, Bénédicte Demeyere, Geert Claeys, Jerina Boelens, Elizaveta Padalko, Johny Verschakelen, GEORGES VAN MAELE, Ellen Deschepper, and Guy Joos. 2013. “Azithromycin for Prevention of Exacerbations in Severe Asthma (AZISAST): a Multicentre Randomised Double-blind Placebo-controlled Trial.” Thorax 68 (4): 322–329.
Vancouver
1.
Brusselle G, VanderStichele C, Jordens P, Deman R, Slabbynck H, Ringoet V, et al. Azithromycin for prevention of exacerbations in severe asthma (AZISAST): a multicentre randomised double-blind placebo-controlled trial. THORAX. 2013;68(4):322–9.
IEEE
[1]
G. Brusselle et al., “Azithromycin for prevention of exacerbations in severe asthma (AZISAST): a multicentre randomised double-blind placebo-controlled trial,” THORAX, vol. 68, no. 4, pp. 322–329, 2013.
@article{3194897,
  abstract     = {Background : Patients with severe asthma are at increased risk of exacerbations and lower respiratory tract infections (LRTI). Severe asthma is heterogeneous, encompassing eosinophilic and non-eosinophilic (mainly neutrophilic) phenotypes. Patients with neutropilic airway diseases may benefit from macrolides.
Methods : We performed a randomised double-blind placebo-controlled trial in subjects with exacerbation-prone severe asthma. Subjects received low-dose azithromycin (n=55) or placebo (n=54) as add-on treatment to combination therapy of inhaled corticosteroids and long-acting beta(2) agonists for 6 months. The primary outcome was the rate of severe exacerbations and LRTI requiring treatment with antibiotics during the 26-week treatment phase. Secondary efficacy outcomes included lung function and scores on the Asthma Control Questionnaire (ACQ) and Asthma Quality of Life Questionnaire (AQLQ).
Results : The rate of primary endpoints (PEPs) during 6 months was not significantly different between the two treatment groups: 0.75 PEPs (95% CI 0.55 to 1.01) per subject in the azithromycin group versus 0.81 PEPs (95% CI 0.61 to 1.09) in the placebo group (p=0.682). In a predefined subgroup analysis according to the inflammatory phenotype, azithromycin was associated with a significantly lower PEP rate than placebo in subjects with non-eosinophilic severe asthma (blood eosinophilia <= 200/mu l): 0.44 PEPs (95% CI 0.25 to 0.78) versus 1.03 PEPs (95% CI 0.72 to 1.48) (p=0.013). Azithromycin significantly improved the AQLQ score but there were no significant between-group differences in the ACQ score or lung function. Azithromycin was well tolerated, but was associated with increased oropharyngeal carriage of macrolide-resistant streptococci.
Conclusions : Azithromycin did not reduce the rate of severe exacerbations and LRTI in patients with severe asthma. However, the significant reduction in the PEP rate in azithromycin-treated patients with non-eosinophilic severe asthma warrants further study.},
  author       = {Brusselle, Guy and VanderStichele, Christine and Jordens, Paul and Deman, René and Slabbynck, Hans and Ringoet, Veerle and Verleden, Geert and Demedts, Ingel K and Verhamme, Katia and Delporte, Anja and Demeyere, Bénédicte and Claeys, Geert and Boelens, Jerina and Padalko, Elizaveta and Verschakelen, Johny and VAN MAELE, GEORGES and Deschepper, Ellen and Joos, Guy},
  issn         = {0040-6376},
  journal      = {THORAX},
  keywords     = {CLINICAL-PRACTICE,EOSINOPHILIC ASTHMA,CHLAMYDIA-PNEUMONIAE,OBSTRUCTIVE PULMONARY-DISEASE,CYSTIC-FIBROSIS,CLARITHROMYCIN,THERAPY,BRONCHIECTASIS,IDENTIFICATION,ROXITHROMYCIN},
  language     = {eng},
  number       = {4},
  pages        = {322--329},
  title        = {Azithromycin for prevention of exacerbations in severe asthma (AZISAST): a multicentre randomised double-blind placebo-controlled trial},
  url          = {http://dx.doi.org/10.1136/thoraxjnl-2012-202698},
  volume       = {68},
  year         = {2013},
}

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