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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Tiotropium in asthma poorly controlled with standard combination therapy
New England Journal of Medicine, Volume 367, No. 13, Year 2012
Notification
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Description
BACKGROUND: Some patients with asthma have frequent exacerbations and persistent airflow obstruction despite treatment with inhaled glucocorticoids and long-acting beta-agonists (LABAs). METHODS: In two replicate, randomized, controlled trials involving 912 patients with asthma who were receiving inhaled glucocorticoids and LABAs, we compared the effect on lung function and exacerbations of adding tiotropium (a total dose of 5 μg) or placebo, both delivered by a soft-mist inhaler once daily for 48 weeks. All the patients were symptomatic, had a post-bronchodilator forced expiratory volume in 1 second (FEV1) of 80% or less of the predicted value, and had a history of at least one severe exacerbation in the previous year. RESULTS: The patients had a mean baseline FEV1 of 62% of the predicted value; the mean age was 53 years. At 24 weeks, the mean (±SE) change in the peak FEV1 from baseline was greater with tiotropium than with placebo in the two trials: a difference of 86±34 ml in trial 1 (P = 0.01) and 154±32 ml in trial 2 (P<0.001). The predose (trough) FEV1 also improved in trials 1 and 2 with tiotropium, as compared with placebo: a difference of 88±31 ml (P = 0.01) and 111±30 ml (P<0.001), respectively. The addition of tiotropium increased the time to the first severe exacerbation (282 days vs. 226 days), with an overall reduction of 21% in the risk of a severe exacerbation (hazard ratio, 0.79; P = 0.03). No deaths occurred; adverse events were similar in the two groups. CONCLUSIONS: In patients with poorly controlled asthma despite the use of inhaled glucocorticoids and LABAs, the addition of tiotropium significantly increased the time to the first severe exacerbation and provided modest sustained bronchodilation. (Funded by Boehringer Ingelheim and Pfizer; ClinicalTrials.gov numbers, NCT00772538 and NCT00776984.) Copyright © 2012 Massachusetts Medical Society.
Authors & Co-Authors
Kerstjens, Huib A.M.
Netherlands, Groningen
Universitair Medisch Centrum Groningen
Engel, Michael
Germany, Ingelheim am Rhein
Boehringer Ingelheim International Gmbh
Dahl, Ronald
Denmark, Aarhus
Aarhus Universitetshospital
Paggiaro, Pierluigi
Italy, Pisa
Azienda Ospedaliero Universitaria Pisana
Beck, Ekkehard
Germany
Institut Für Gesundheitsförderung
Vandewalker, Mark L.
United States, Columbia
Clinical Research of the Ozarks
Sigmund, Ralf
Germany, Ingelheim am Rhein
Boehringer Ingelheim International Gmbh
Seibold, Wolfgang
Germany, Ingelheim am Rhein
Boehringer Ingelheim International Gmbh
Moroni-Zentgraf, Petra M.
Germany, Ingelheim am Rhein
Boehringer Ingelheim International Gmbh
Bateman, E. D.
South Africa, Cape Town
University of Cape Town
Statistics
Citations: 594
Authors: 10
Affiliations: 7
Identifiers
Doi:
10.1056/NEJMoa1208606
ISSN:
00284793
e-ISSN:
15334406
Research Areas
Environmental