Clinical trial NCT00430729: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112)
Official title: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52 Weeks Double Blind Study With 500mcg Roflumilast Once Daily Versus Placebo. Ratio-Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
COPD
Keywords: Roflumilast
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-02-02
Enrollment: 1100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of 500mcg roflumilast vs placebo on exacerbation rate and pulmonary function as well as quality of life in patients with chronic obstructive pulmonary disease (COPD).


Eligibility criteria: Main Inclusion Criteria:

* FEV1/FVC ratio (post-bronchodilator) ≤70%
* FEV1 (post-bronchodilator) ≤50% of predicted
* Current smoker or ex-smoker
* Clinically stable COPD indicated by no exacerbation and no change in COPD treatment of within 4 weeks prior to baseline
* Availability of a chest x-ray dated a maximum of 6 months prior to study baseline visit B0 or a willingness to have a chest x-ray performed before baseline

Main Exclusion Criteria:

* COPD exacerbation indicated by a treatment with systemic glucocorticoids not stopped 4 weeks prior to baseline
* Lower respiratory tract infection not resolved 4 weeks prior to baseline
* Diagnosis of asthma and/or other relevant lung disease
* Known alpha-1-antitrypsin deficiency
* Need for long-term oxygen therapy defined as ≥16 hours/day

Primary outcomes:
measure: The frequency of patients experiencing at least one moderate or severe exacerbation during the treatment period.
measure: Change in FEV1 from baseline during the treatment period.
Secondary outcomes:
measure: Pulmonary function variables; quality of life variables;patient diary variables;safety
Other outcomes:
Locations:
city: Cities in Australia
country: Australia
facility: ALTANA Pharma
city: Cities in Austria
country: Austria
facility: ALTANA Pharma
city: Cities in Canada
country: Canada
facility: ALTANA Pharma
city: Cities in France
country: France
facility: ALTANA Pharma
city: Cities in Hungary
country: Hungary
facility: ALTANA Pharma
city: Cities in Italy
country: Italy
facility: ALTANA Pharma
city: Cities in the Netherlands
country: Netherlands
facility: ALTANA Pharma
city: Cities in Poland
country: Poland
facility: ALTANA Pharma
city: Cities in Portugal
country: Portugal
facility: ALTANA Pharma
city: Cities in the Russian Federation
country: Russian Federation
facility: ALTANA Pharma
city: Cities in South Africa
country: South Africa
facility: ALTANA Pharma
city: Cities in Spain
country: Spain
facility: ALTANA Pharma
city: Cities in Switzerland
country: Switzerland
facility: ALTANA Pharma
city: Cities in the United Kingdom
country: United Kingdom
facility: ALTANA Pharma
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
citation: Facius A, Krause A, Claret L, Bruno R, Lahu G. Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast. J Clin Pharmacol. 2017 Aug;57(8):1042-1052. doi: 10.1002/jcph.885. Epub 2017 Apr 17.
citation: Rennard SI, Calverley PM, Goehring UM, Bredenbroker D, Martinez FJ. Reduction of exacerbations by the PDE4 inhibitor roflumilast--the importance of defining different subsets of patients with COPD. Respir Res. 2011 Jan 27;12(1):18. doi: 10.1186/1465-9921-12-18.