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Completed

NCT Number: NCT00076089

OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)

The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD).

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Key information

Conditions

Chronic Obstructive Pulmonary Disease COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ALTANA Pharma, Cities in Canada, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 chest x-ray dated a maximum of 6 months prior to study baseline or a willingness to have a chest x-ray performed at 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

Treatment and study plan

Roflumilast

Drug

Primary outcomes

  1. change in FEV1 from baseline during the treatment period; number of COPD exacerbations.

Secondary outcomes

  1. pulmonary function variables

  2. number of COPD exacerbations of different type and various subgroups

  3. quality of life variables

  4. patient diary variables

  5. time to study withdrawal

  6. safety.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52-week, Multicenter, Double-blind Study With 500 mcg Roflumilast Once Daily Versus Placebo.

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Jan 15, 2004
Registry last updated
Dec 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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