Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112)

Chronic Obstructive Pulmonary Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00430729
• Other study ID #: BY217/M2-112
• Status: Completed
• Phase: Phase 3
• First received: February 1, 2007
• Last updated: November 29, 2016
• Start date: January 2003

Study information

• Verified date: September 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Roflumilast

Locations

Country	Name	City	State
Australia	ALTANA Pharma	Cities in Australia
Austria	ALTANA Pharma	Cities in Austria
Canada	ALTANA Pharma	Cities in Canada
France	ALTANA Pharma	Cities in France
Hungary	ALTANA Pharma	Cities in Hungary
Italy	ALTANA Pharma	Cities in Italy
Netherlands	ALTANA Pharma	Cities in the Netherlands
Poland	ALTANA Pharma	Cities in Poland
Portugal	ALTANA Pharma	Cities in Portugal
Russian Federation	ALTANA Pharma	Cities in the Russian Federation
South Africa	ALTANA Pharma	Cities in South Africa
Spain	ALTANA Pharma	Cities in Spain
Switzerland	ALTANA Pharma	Cities in Switzerland
United Kingdom	ALTANA Pharma	Cities in the United Kingdom

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Australia,  Austria,  Canada,  France,  Hungary,  Italy,  Netherlands,  Poland,  Portugal,  Russian Federation,  South Africa,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency of patients experiencing at least one moderate or severe exacerbation during the treatment period.
Primary	Change in FEV1 from baseline during the treatment period.
Secondary	Pulmonary function variables; quality of life variables;patient diary variables;safety

External Links

•   BY217-M2-112-RDS-2005-05-11.pdf