Efficacy and Safety of Oral Roflumilast Taken Once Daily in Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (BY217/M2-119)

Study Overview
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Brief Summary
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The aim of the study is to compare the effect of roflumilast on lung function in patients with COPD. Roflumilast will be administered orally once daily in the morning at one dose level. The study duration consists of a baseline period (4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of roflumilast.

Official Title
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The JADE Study: A 12-week, Double-blind, Randomized Study to Investigate the Effect of 500 mcg Roflumilast Tablets Once Daily Versus Placebo on Pulmonary Function in Patients With Chronic Obstructive Pulmonary Disease

Conditions
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COPD

Intervention / Treatment
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* Drug: Roflumilast
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Written informed consent Patients with a history of chronic obstructive pulmonary disease (COPD) as defined by the GOLD criteria (2003) FEV1/FVC ratio (post bronchodilator) smaller or equal 70% FEV1 (post bronchodilator) 30-80% of predicted Fixed airway obstruction Current smoker or former smoker (smoking cessation at least one year ago) with a smoking history of at least 10 pack years Clinically stable COPD within 4 weeks prior to baseline visit Availability of a chest x-ray Main Exclusion Criteria: COPD exacerbation indicated by a treatment with systemic glucocorticosteroids Lower respiratory tract infection Diagnosis of asthma Known alpha-1-antitrypsin deficiency Need for long term oxygen therapy defined as longer or equal 16 hours/day Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator) Known infection with HIV, active hepatitis and/or liver insufficiency (according to the Child Pugh score A or worse) Diagnosis or history of cancer Clinically significant cardiopulmonary abnormalities Pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial Female patients of childbearing potential, not using reliable method of contraception for the entire study duration, post-menopausal > 1 year or who are not using any other method considered sufficiently reliable by the investigator in individual cases Participation in another study (use of investigational product) within 30 days preceding the baseline visit or re-entry of patients already enroled in this trial Alcohol or drug abuse Inability to follow the study procedures due to e.g., language problems, physiological disorders Use of not allowed drugs Suspected hypersensitivity to the study medication or rescue medication

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Roflumilast 500 µg | Drug: Roflumilast<br>* to investigate the effect of 500 µg Roflumilast tablets once daily versus placebo<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Roflumilast<br>* to investigate the effect of 500 µg Roflumilast tablets once daily versus placebo<br>Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean change from randomization to endpoint in lung function (post bronchodilator) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean change from randomization to endpoint in pre and post bronchodilator spirometric parameters |  | 12 weeks | 
| exacerbation rate |  | 12 weeks | 
| adverse events |  | 12 weeks | 
| changes in laboratory values |  | 12 weeks | 
| changes in vital signs |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, chronic obstructive pulmonary disease, Roflumilast