Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)

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 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).

Official Title
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Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The HERMES Study

Conditions
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Chronic Obstructive Pulmonary Disease (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: COPD patients having at least one exacerbation within last year FEV1/FVC ratio (post-bronchodilator) ≤ 70% FEV1 (post-bronchodilator) ≤ 50% of predicted Main Exclusion Criteria: COPD exacerbation not resolved at first baseline visit Diagnosis of asthma and/or other relevant lung disease

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: Roflumilast<br>500 mcg, once daily, oral administration in the morning | Drug: Roflumilast<br>* 500 mcg, once daily, oral administration in the morning<br>|
| Placebo Comparator: Placebo<br>once daily | Drug: Placebo<br>* once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-bronchodilator FEV1 [L] | Mean change from baseline during the treatment period in 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) | Mean change from baseline to the last post randomization measurement in natural log-transformed CRP | Change from baseline to last post randomization measurement (52 weeks) | 
| Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period | The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9. | Change from baseline over 52 weeks of treatment | 

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