The HERO-study: Effects of Roflumilast in Patients With COPD (Chronic Obstructive Pulmonary Disease) (BY217/M2-121)
NCT00108823 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 550
Last updated 2016-10-26
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
Interventions
- DRUG
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
AstraZeneca AstraZeneca · AstraZeneca
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-10-31
Countries
- United States
- Canada
- France
- Poland
- South Africa
- Spain
- United Kingdom
More Related Trials
-
Effect of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease
NCT01473758 ·Status: TERMINATED ·Phase: PHASE2
-
Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Combinations of Long-acting β2-agonists (LABA) and Inhaled Glucocorticosteroid (ICS)
NCT01329029 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluation of Tolerability and Pharmacokinetics of Roflumilast, 250μg and 500μg, as add-on to Standard COPD Treatment to Treat Severe COPD
NCT02165826 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)
NCT00297102 ·Status: COMPLETED ·Phase: PHASE3
-
Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
NCT01443845 ·Status: COMPLETED ·Phase: PHASE4
-
Long-term Observational Study of the Safety of Roflumilast
NCT03381573 ·Status: COMPLETED
-
A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore:
NCT01313494 ·Status: COMPLETED ·Phase: PHASE3
-
The Effectiveness of Roflumilast in Improving Mucociliary Clearance in Patients With COPD and Chronic Bronchitis
NCT03073798 ·Status: COMPLETED ·Phase: PHASE4
-
OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)
NCT00076089 ·Status: COMPLETED ·Phase: PHASE3
-
Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08)
NCT00246935 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Oral Roflumilast Taken Once Daily in Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (BY217/M2-119)
NCT00242320 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06)
NCT00242294 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127)
NCT00313209 ·Status: COMPLETED ·Phase: PHASE3
-
Roflumilast Safety Administered Once a Day on Alternate Days for Two Weeks Compared to the Usual Dosage Once Daily
NCT01849341 ·Status: COMPLETED ·Phase: PHASE4
-
Pharmacokinetic Study of Single and Repeated Dose of Roflumilast 500 µg , in Healthy Chinese Subjects
NCT01354782 ·Status: COMPLETED ·Phase: PHASE1
-
Effects of Roflumilast in Hospitalized Chronic Obstructive Pulmonary Disease( COPD) on Mortality and Re-hospitalization
NCT01973998 ·Status: COMPLETED ·Phase: PHASE3
-
A Multi-center Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of R7103 Following Repeated Inhalation in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease
NCT01009424 ·Status: WITHDRAWN ·Phase: PHASE1
-
Effects of ROFLUMILAST on Subclinical Atherosclerosis in Chronic Obstructive Pulmonary Disease (COPD)
NCT01630200 ·Status: COMPLETED ·Phase: PHASE4
-
BI 113608 Administered as Tablets Twice Daily Over 4 Weeks in Patients With Chronic Obstructive Pulmonary Disease Associated With Chronic Bronchitis
NCT01958008 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy, Pharmacokinetics (PK), Safety and Tolerability Study of Inhaled AZD8871
NCT02971293 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of Roflumilast on Airway Blood Flow as an Expression of Airway Inflammation in COPD
NCT02097992 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Evaluation of Clinical Effectiveness of Roflumilast in Routine Practice, in Chronic Obstructive Pulmonary Disease (COPD) Patients in Greece
NCT02187926 ·Status: COMPLETED
-
Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Roflumilast on Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease
NCT01595750 ·Status: UNKNOWN ·Phase: PHASE4
-
Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Bronchiectasis
NCT03988816 ·Status: UNKNOWN ·Phase: PHASE2
-
A Single-dose Study to Investigate the Effects of 3 Different Doses of Inhaled AZD2115 in COPD Patients
NCT01498081 ·Status: COMPLETED ·Phase: PHASE2