Heterogeneity of treatment response in bronchiectasis clinical trials.
Journal
The European respiratory journal
ISSN: 1399-3003
Titre abrégé: Eur Respir J
Pays: England
ID NLM: 8803460
Informations de publication
Date de publication:
05 2022
05 2022
Historique:
received:
20
06
2019
accepted:
15
09
2021
pubmed:
23
10
2021
medline:
10
5
2022
entrez:
22
10
2021
Statut:
epublish
Résumé
Recent randomised clinical trials in bronchiectasis have failed to reach their primary end-points, suggesting a need to reassess how we measure treatment response. Exacerbations, quality of life (QoL) and lung function are the most common end-points evaluated in bronchiectasis clinical trials. We aimed to determine the relationship between responses in terms of reduced exacerbations, improved symptoms and lung function in bronchiectasis. We evaluated treatment response in three randomised clinical trials that evaluated mucoactive therapy (inhaled mannitol), an oral anti-inflammatory/antibiotic (azithromycin) and an inhaled antibiotic (aztreonam). Treatment response was defined by an absence of exacerbations during follow-up, an improvement of QoL above the minimum clinically important difference and an improvement in forced expiratory volume in 1 s (FEV Cumulatively the three trials included 984 patients. Changes in FEV Improvements in lung function, symptoms and exacerbation frequency are dissociated in bronchiectasis. FEV
Sections du résumé
BACKGROUND
Recent randomised clinical trials in bronchiectasis have failed to reach their primary end-points, suggesting a need to reassess how we measure treatment response. Exacerbations, quality of life (QoL) and lung function are the most common end-points evaluated in bronchiectasis clinical trials. We aimed to determine the relationship between responses in terms of reduced exacerbations, improved symptoms and lung function in bronchiectasis.
METHODS
We evaluated treatment response in three randomised clinical trials that evaluated mucoactive therapy (inhaled mannitol), an oral anti-inflammatory/antibiotic (azithromycin) and an inhaled antibiotic (aztreonam). Treatment response was defined by an absence of exacerbations during follow-up, an improvement of QoL above the minimum clinically important difference and an improvement in forced expiratory volume in 1 s (FEV
RESULTS
Cumulatively the three trials included 984 patients. Changes in FEV
CONCLUSIONS
Improvements in lung function, symptoms and exacerbation frequency are dissociated in bronchiectasis. FEV
Identifiants
pubmed: 34675045
pii: 13993003.00777-2021
doi: 10.1183/13993003.00777-2021
pii:
doi:
Substances chimiques
Anti-Bacterial Agents
0
Mannitol
3OWL53L36A
Azithromycin
83905-01-5
Aztreonam
G2B4VE5GH8
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : Medical Research Council
ID : MR/L011263/1
Pays : United Kingdom
Informations de copyright
Copyright ©The authors 2022. For reproduction rights and permissions contact permissions@ersnet.org.
Déclaration de conflit d'intérêts
Conflict of interest: O. Sibila has nothing to disclose. Conflict of interest: E. Laserna has nothing to disclose. Conflict of interest: A. Shoemark has nothing to disclose. Conflict of interest: L. Perea has nothing to disclose. Conflict of interest: D. Bilton has nothing to disclose. Conflict of interest: M.L. Crichton reports personal fees from AstraZeneca, outside the submitted work. Conflict of interest: A. De Soyza reports grants, travel support to attend international congresses and lecture fees from AstraZeneca, Bayer, Chiesi, Grifols, GlaxoSmithKline, Insmed, Pfizer, Novartis, Medimmune and Zambon, outside the submitted work. Conflict of interest: W.G. Boersma has nothing to disclose. Conflict of interest: J. Altenburg has nothing to disclose. Conflict of interest: J.D. Chalmers reports grants and personal fees from GlaxoSmithKline, Grifols, Boehringer Ingelheim and Insmed, grants from AstraZeneca and Bayer Healthcare, personal fees from Aradigm, Pfizer and Napp, outside the submitted work.