The HERO-study: Effects of Roflumilast in Patients With COPD (Chronic Obstructive Pulmonary Disease) (BY217/M2-121)

October 24, 2016 updated by: AstraZeneca

A 24-week, Double Blind, Randomized Study to Investigate the Effect of 500 µg Roflumilast Tablets Once Daily Versus Placebo on Parameters Indicative of Hyperinflation in Patients With Chronic Obstructive Pulmonary Disease

The purpose of this trial is to study the effects of roflumilast on lung function parameters indicative of hyperinflation in patients with COPD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

550

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Cities in Canada, Canada
        • ALTANA Pharma
  • France
      • Cities in France, France
        • ALTANA Pharma
  • Poland
      • Cities in Poland, Poland
        • ALTANA Pharma
  • South Africa
      • Cities in South Africa, South Africa
        • ALTANA Pharma
  • Spain
      • Cities in Spain, Spain
        • ALTANA Pharma
  • United Kingdom
      • Cities in the United Kingdom, United Kingdom
        • ALTANA Pharma
  • United States
    • California
      • Cities in California, California, United States
        • ALTANA Pharma
    • Colorado
      • Cities in Colorado, Colorado, United States
        • ALTANA Pharma
    • Florida
      • Cities in Florida, Florida, United States
        • ALTANA Pharma
    • Missouri
      • Cities in Missouri, Missouri, United States
        • ALTANA Pharma
    • New Mexico
      • Cities in New Mexico, New Mexico, United States
        • ALTANA Pharma
    • New York
      • Cities in New York, New York, United States
        • ALTANA Pharma
    • Oregon
      • Cities in Oregeon, Oregon, United States
        • ALTANA Pharma
    • South Carolina
      • Cities in South Carolina, South Carolina, United States
        • ALTANA Pharma
    • Texas
      • Cities in Texas, Texas, United States
        • ALTANA Pharma
    • Washington
      • Cities in Washington, Washington, United States
        • ALTANA Pharma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  • Written informed consent
  • Patients with a history of chronic obstructive pulmonary disease for at least 12 months as defined by the GOLD (Global Initiative on Obstructive Lung Diseases) criteria (2003)
  • Age ≥ 40 years
  • FEV1/FVC ratio (post-bronchodilator) ≤ 70%
  • FEV1 (post-bronchodilator) ≤ 65% of predicted
  • FRC (post-bronchodilator) ≤ 120% of predicted
  • Clinically stable COPD within 4 weeks prior to baseline visit (B0).
  • Availability of a chest x-ray dated a maximum of 6 months prior to study baseline visit (B0) or a willingness to have a chest x-ray performed at visit (B0).

Main Exclusion Criteria:

  • COPD exacerbation indicated by a treatment with systemic glucocorticosteroids not stopped at least 4 weeks prior to the baseline visit (B0)
  • Non smoker, current smoker or ex-smoker (smoking cessation at least one year ago) with a smoking history of < 10 pack years
  • Suffering from any concomitant disease that might interfere with study procedures or evaluation
  • Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit (B0)
  • Diagnosis of asthma and/or other relevant lung disease (e.g. history of bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease [e.g. fibrosis, silicosis, sarcoidosis], and active tuberculosis)
  • Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 2 months preceding the baseline visit (B0).
  • Known alpha-1-antitrypsin deficiency
  • Need for long term oxygen therapy defined as ≥ 15 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
  • Diagnosis or history of cancer (other than basal cell carcinoma) or recurrence within 5 years prior to study start
  • Clinically significant cardiopulmonary abnormalities (diagnosed clinically or by x-ray/ECG) that are not related to COPD and that require further evaluation
  • Pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial
  • The female patient is of childbearing potential and is not using and is not willing to continue to use a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless she is surgically sterilized/hysterectomized or post-menopausal > 1 year or any other criteria considered sufficiently reliable by the investigator in individual cases
  • Participation in another study (use of investigational product) within 30 days preceding the baseline visit (B0) or re-entry of patients already enrolled in this trial
  • Suspected inability or unwillingness to comply with study procedures
  • Alcohol or drug abuse
  • Inability to follow study procedures due to, for example, language problems or psychological disorders
  • Use of prohibited drugs
  • Suspected hypersensitivity to the study medication and/or contraindication to any ingredients of the study medication (roflumilast) or rescue medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Lung function parameters indicative of hyperinflation in patients with COPD

Secondary Outcome Measures

Outcome Measure
Mean change from randomization to endpoint in additional pre and post bronchodilator spirometric and lung volume parameters
Measurement of quality of life parameters and dyspnea

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Registration Dates

First Submitted

April 19, 2005

First Submitted That Met QC Criteria

April 19, 2005

First Posted (Estimate)

April 20, 2005

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BY217/M2-121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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