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

Chronic Obstructive Pulmonary Disease, COPD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00108823
• Other study ID #: BY217/M2-121
• Status: Completed
• Phase: Phase 3
• First received: April 19, 2005
• Last updated: October 24, 2016
• Start date: October 2004

Study information

• Verified date: September 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease, COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Roflumilast

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada,  France,  Poland,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung function parameters indicative of hyperinflation in patients with COPD
Secondary	Mean change from randomization to endpoint in additional pre and post bronchodilator spirometric and lung volume parameters
Secondary	Measurement of quality of life parameters and dyspnea

External Links

•   BY217-M2-121-RDS-2008-12-23.pdf