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Completed

NCT Number: NCT00297115

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

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).

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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/Nycomed Investigational Site, Calgary, Alberta, 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:

  • 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

Treatment and study plan

Roflumilast

Drug

500 mcg, once daily, oral administration in the morning

Placebo

Drug

once daily

Primary outcomes

  1. Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)

    Time frame: Change from baseline over 52 weeks of treatment

    Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]

  2. COPD Exacerbation Rate (Moderate or Severe)

    Time frame: 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].

Secondary outcomes

  1. Post-bronchodilator FEV1 [L]

    Time frame: Change from baseline over 52 weeks of treatment

    Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]

  2. Time to Mortality Due to Any Reason

    Time frame: 52 weeks treatment period

  3. Natural Log-transformed C-reactive Protein (CRP)

    Time frame: 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

  4. Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 28, 2006
Registry last updated
Nov 7, 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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