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

NCT ID: NCT00430729

Last Updated: 2016-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease COPD

Keywords

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Roflumilast

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Roflumilast

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AstraZeneca AstraZeneca

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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ALTANA Pharma

Cities in Australia, , Australia

Site Status

ALTANA Pharma

Cities in Austria, , Austria

Site Status

ALTANA Pharma

Cities in Canada, , Canada

Site Status

ALTANA Pharma

Cities in France, , France

Site Status

ALTANA Pharma

Cities in Hungary, , Hungary

Site Status

ALTANA Pharma

Cities in Italy, , Italy

Site Status

ALTANA Pharma

Cities in the Netherlands, , Netherlands

Site Status

ALTANA Pharma

Cities in Poland, , Poland

Site Status

ALTANA Pharma

Cities in Portugal, , Portugal

Site Status

ALTANA Pharma

Cities in the Russian Federation, , Russia

Site Status

ALTANA Pharma

Cities in South Africa, , South Africa

Site Status

ALTANA Pharma

Cities in Spain, , Spain

Site Status

ALTANA Pharma

Cities in Switzerland, , Switzerland

Site Status

ALTANA Pharma

Cities in the United Kingdom, , United Kingdom

Site Status

Countries

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Australia Austria Canada France Hungary Italy Netherlands Poland Portugal Russia South Africa Spain Switzerland United Kingdom

References

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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.

Reference Type DERIVED
PMID: 28419462 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21272339 (View on PubMed)

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4478&filename=BY217-M2-112-RDS-2005-05-11.pdf

BY217-M2-112-RDS-2005-05-11.pdf

Other Identifiers

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BY217/M2-112

Identifier Type: -

Identifier Source: org_study_id