Brief Summary

The aim of the study is to compare the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will be up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast. For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).

Trial Health

On Track

Trial Health Score

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

Enrollment

1,568

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Mar 2006

Geographic Reach

8 countries

287 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

2.4 years study duration

First Submitted

Initial submission to the registry

February 27, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2006

Completed

1 day until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed

2.8 years until next milestone

Results Posted

Study results publicly available

May 19, 2011

Completed

Last Updated

November 7, 2016

Status Verified

September 1, 2016

Enrollment Period

2.1 years

First QC Date

February 27, 2006

Results QC Date

March 17, 2011

Last Update Submit

October 3, 2016

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

RoflumilastCOPDChronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (2)

Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)
Mean change from baseline during the treatment period in pre-bronchodilator FEV1 \[L\]
Change from baseline over 52 weeks of treatment
COPD Exacerbation Rate (Moderate or Severe)
Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management \[American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005\].
52 weeks treatment period

Secondary Outcomes (4)

Post-bronchodilator FEV1 [L]
Change from baseline over 52 weeks of treatment
Time to Mortality Due to Any Reason
52 weeks treatment period
Natural Log-transformed C-reactive Protein (CRP)
Change from baseline to last post randomization measurement (52 weeks)
Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period
Change from baseline over 52 weeks of treatment

Study Arms (2)

Roflumilast

ACTIVE COMPARATOR

500 mcg, once daily, oral administration in the morning

Drug: Roflumilast

Placebo

PLACEBO COMPARATOR

once daily

Drug: Placebo

Interventions

RoflumilastDRUG

500 mcg, once daily, oral administration in the morning

Roflumilast

PlaceboDRUG

once daily

Placebo

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

COPD patients having at least one exacerbation within last year
FEV1/FVC ratio (post-bronchodilator) ≤ 70%
FEV1 (post-bronchodilator) ≤ 50% of predicted

You may not qualify if:

COPD exacerbation not resolved at first baseline visit
Diagnosis of asthma and/or other relevant lung disease

Contact the study team to confirm eligibility.