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

NCT00108823 | Completed Phase 3

• 1 other identifier: BY217/M2-121
• Study Type: interventional
• Target: 550
• Locations: 7 countries
• Sites: 16

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease, COPD

Outcome Measures

Primary Outcomes (1)

• Lung function parameters indicative of hyperinflation in patients with COPD

Secondary Outcomes (2)

• 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

Interventions

Roflumilast DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (16)

ALTANA Pharma

Cities in California, California, United States

Location

ALTANA Pharma

Cities in Colorado, Colorado, United States

Location

ALTANA Pharma

Cities in Florida, Florida, United States

Location

ALTANA Pharma

Cities in Missouri, Missouri, United States

Location

ALTANA Pharma

Cities in New Mexico, New Mexico, United States

Location

ALTANA Pharma

Cities in New York, New York, United States

Location

ALTANA Pharma

Cities in Oregeon, Oregon, United States

Location

ALTANA Pharma

Cities in South Carolina, South Carolina, United States

Location

ALTANA Pharma

Cities in Texas, Texas, United States

Location

ALTANA Pharma

Cities in Washington, Washington, United States

Location

ALTANA Pharma

Cities in Canada, Canada

Location

ALTANA Pharma

Cities in France, France

Location

ALTANA Pharma

Cities in Poland, Poland

Location

ALTANA Pharma

Cities in South Africa, South Africa

Location

ALTANA Pharma

Cities in Spain, Spain

Location

ALTANA Pharma

Cities in the United Kingdom, United Kingdom

Location

Related Links

• BY217-M2-121-RDS-2008-12-23.pdf

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2005
• First Posted: April 20, 2005
• Study Start: October 1, 2004
• Last Updated: October 26, 2016

Record last verified: 2016-09

Locations

GB (1); CA (1); PL (1); FR (1); US (10); ZA (1); ES (1)