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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00108823
First received: April 19, 2005
Last updated: May 4, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease, COPD
Drug: Roflumilast
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Lung function parameters indicative of hyperinflation in patients with COPD

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 550
Study Start Date: October 2004
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108823

Locations
United States, California
ALTANA Pharma
Cities in California, California, United States
United States, Colorado
ALTANA Pharma
Cities in Colorado, Colorado, United States
United States, Florida
ALTANA Pharma
Cities in Florida, Florida, United States
United States, Missouri
ALTANA Pharma
Cities in Missouri, Missouri, United States
United States, New Mexico
ALTANA Pharma
Cities in New Mexico, New Mexico, United States
United States, New York
ALTANA Pharma
Cities in New York, New York, United States
United States, Oregon
ALTANA Pharma
Cities in Oregeon, Oregon, United States
United States, South Carolina
ALTANA Pharma
Cities in South Carolina, South Carolina, United States
United States, Texas
ALTANA Pharma
Cities in Texas, Texas, United States
United States, Washington
ALTANA Pharma
Cities in Washington, Washington, United States
Canada
ALTANA Pharma
Cities in Canada, Canada
France
ALTANA Pharma
Cities in France, France
Poland
ALTANA Pharma
Cities in Poland, Poland
South Africa
ALTANA Pharma
Cities in South Africa, South Africa
Spain
ALTANA Pharma
Cities in Spain, Spain
United Kingdom
ALTANA Pharma
Cities in the United Kingdom, United Kingdom
Sponsors and Collaborators
Takeda
Investigators
Study Director: D. Bredenbröker, MD ALTANA Pharma AG
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00108823     History of Changes
Other Study ID Numbers: BY217/M2-121
Study First Received: April 19, 2005
Last Updated: May 4, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014