NCT00430729

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).

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for phase_3 chronic-obstructive-pulmonary-disease

Geographic Reach
13 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2007

Completed
Last Updated

November 30, 2016

Status Verified

September 1, 2016

First QC Date

February 1, 2007

Last Update Submit

November 29, 2016

Conditions

Chronic Obstructive Pulmonary DiseaseCOPD

Keywords

Roflumilast

Outcome Measures

Primary Outcomes (2)

  • The frequency of patients experiencing at least one moderate or severe exacerbation during the treatment period.

  • Change in FEV1 from baseline during the treatment period.

Secondary Outcomes (1)

  • Pulmonary function variables; quality of life variables;patient diary variables;safety

Interventions

RoflumilastDRUG

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

ALTANA Pharma

Cities in Australia, Australia

Location

ALTANA Pharma

Cities in Austria, Austria

Location

ALTANA Pharma

Cities in Canada, Canada

Location

ALTANA Pharma

Cities in France, France

Location

ALTANA Pharma

Cities in Hungary, Hungary

Location

ALTANA Pharma

Cities in Italy, Italy

Location

ALTANA Pharma

Cities in the Netherlands, Netherlands

Location

ALTANA Pharma

Cities in Poland, Poland

Location

ALTANA Pharma

Cities in Portugal, Portugal

Location

ALTANA Pharma

Cities in the Russian Federation, Russia

Location

ALTANA Pharma

Cities in South Africa, South Africa

Location

ALTANA Pharma

Cities in Spain, Spain

Location

ALTANA Pharma

Cities in Switzerland, Switzerland

Location

ALTANA Pharma

Cities in the United Kingdom, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 28419462DERIVED

  • 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.

    PMID: 21272339DERIVED

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • AstraZeneca AstraZeneca

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2007

First Posted

February 2, 2007

Study Start

January 1, 2003

Last Updated

November 30, 2016

Record last verified: 2016-09

Locations

CA(1)AU(1)ZA(1)FR(1)IT(1)PT(1)CH(1)NL(1)ES(1)GB(1)RU(1)PL(1)HU(1)