Randomized Double-Blind Controlled Trial of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Treatment failure with the current standard of care is 27% at 30 days (4) and rises to 37% at 90 days (5). [...]new therapies for the management of acute exacerbations are urgently needed. Roflumilast reduces neutrophilic airway inflammation (6), improves lung function, and reduces exacerbations in...

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Published in:American journal of respiratory and critical care medicine 2017-09, Vol.196 (5), p.656-659
Main Authors: Mackay, Alex J, Patel, Anant R C, Singh, Richa, Sapsford, Raymond J, Donaldson, Gavin C, Prasad, Niyati, Goehring, Udo-Michael, Nip, Tsz Keung, Wedzicha, Jadwiga A
Format: Article
Language:English
Subjects:
Aged
Aged, 80 and over
Aminopyridines - therapeutic use
Benzamides - therapeutic use
Chronic obstructive pulmonary disease
Clinical trials
Cyclopropanes - therapeutic use
Disease Progression
Double-Blind Method
Evidence-based medicine
Female
Forced Expiratory Volume
Health risk assessment
Humans
Inflammation
Leukocyte Count
London
Male
Middle Aged
Mortality
Neutrophils
Neutrophils - cytology
Neutrophils - immunology
Patients
Phosphodiesterase 4 Inhibitors - therapeutic use
Pulmonary Disease, Chronic Obstructive - drug therapy
Pulmonary Disease, Chronic Obstructive - immunology
Pulmonary Disease, Chronic Obstructive - physiopathology
Sputum - cytology
Thorax
Treatment Outcome
University colleges
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Summary:Treatment failure with the current standard of care is 27% at 30 days (4) and rises to 37% at 90 days (5). [...]new therapies for the management of acute exacerbations are urgently needed. Roflumilast reduces neutrophilic airway inflammation (6), improves lung function, and reduces exacerbations in stable patients with COPD (7-9), but it has not previously been studied as an acute exacerbation therapy. [...]we conducted a randomized, double-blind, placebo-controlled study to test the hypothesis that roflumilast reduces neutrophilic inflammation during exacerbations of COPD when added to usual medication. Faster resolution of neutrophilic inflammation is associated with shorter clinical recovery (10). [...]this study served as a proof-of-mechanism study to examine whether roflumilast can improve clinical recovery after COPD exacerbations. [...]in exploratory analyses, at 4 weeks, patients treated with roflumilast experienced a statistically significant greater reduction in percentage sputum neutrophils and sputum myeloperoxidase concentration. [...]roflumilast use led to trends in benefits in lung function.
ISSN:1073-449X
1535-4970
DOI:10.1164/rccm.201612-2518LE