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

Overview

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).

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: December 2005

Interventions

  • Drug: Roflumilast

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • pulmonary function variables
  • number of COPD exacerbations of different type and various subgroups
  • quality of life variables
  • patient diary variables
  • time to study withdrawal
  • safety.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • AstraZeneca AstraZeneca, Study Director, AstraZeneca

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