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

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: Placebo; Drug: Roflumilast

• Registration Number: NCT00297115
• Lead Sponsor: AstraZeneca

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-02-27
• Study First Submitted QC: 2006-02-27
• Study First Posted: 2006-02-28
• Study Start: 2006-03
• Primary Completion: 2008-04
• Study Completion: 2008-08
• Results First Submitted: 2011-03-17
• Results First Submitted QC: 2011-04-20
• Results First Posted: 2011-05-19
• Status Verified: 2016-09
• Last Update Submitted: 2016-10-03
• Last Update Posted: 2016-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1568

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	once daily
Roflumilast	Roflumilast	500 mcg, once daily, oral administration in the morning

Primary Outcome Measures

Name	Time	Method
COPD Exacerbation Rate (Moderate or Severe)	52 weeks treatment period	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 \[American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005\].
Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)	Change from baseline over 52 weeks of treatment	Mean change from baseline during the treatment period in pre-bronchodilator FEV1 \[L\]

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Altana Pharma/Nycomed Investigational Site; 🇪🇸 Valencia, Spain