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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00108823
• Collaborator: (none)
• Enrollment: 550
• Locations: 16
• Patients Per Site: 34.4

Study Details

Study Description

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.

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

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• 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
• Study Start Date: Oct 1, 2004

Outcome Measures

Primary Outcome Measures

1. Lung function parameters indicative of hyperinflation in patients with COPD []

Secondary Outcome Measures

1. Mean change from randomization to endpoint in additional pre and post bronchodilator spirometric and lung volume parameters []

2. Measurement of quality of life parameters and dyspnea []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	ALTANA Pharma	Cities in California	California	United States
2	ALTANA Pharma	Cities in Colorado	Colorado	United States
3	ALTANA Pharma	Cities in Florida	Florida	United States
4	ALTANA Pharma	Cities in Missouri	Missouri	United States
5	ALTANA Pharma	Cities in New Mexico	New Mexico	United States
6	ALTANA Pharma	Cities in New York	New York	United States
7	ALTANA Pharma	Cities in Oregeon	Oregon	United States
8	ALTANA Pharma	Cities in South Carolina	South Carolina	United States
9	ALTANA Pharma	Cities in Texas	Texas	United States
10	ALTANA Pharma	Cities in Washington	Washington	United States
11	ALTANA Pharma	Cities in Canada		Canada
12	ALTANA Pharma	Cities in France		France
13	ALTANA Pharma	Cities in Poland		Poland
14	ALTANA Pharma	Cities in South Africa		South Africa
15	ALTANA Pharma	Cities in Spain		Spain
16	ALTANA Pharma	Cities in the United Kingdom		United Kingdom

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: AstraZeneca AstraZeneca, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BY217-M2-121-RDS-2008-12-23.pdf

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00108823
• Other Study ID Numbers: BY217/M2-121
• First Posted: Apr 20, 2005
• Last Update Posted: Oct 26, 2016
• Last Verified: Sep 1, 2016

• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Oct 26, 2016