Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00932646
First received: July 2, 2009
Last updated: November 15, 2010
Last verified: November 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: BI 1744 (Olodaterol) Low Dose Drug: BI 1744 (Olodaterol) Medium Dose Drug: Placebo Drug: Foradil |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- The primary objective will be to evaluate whether once daily treatment with 5 mcg or 10 mcg BI 1744 administered via the Respimat device is superior to once daily treatment with Placebo Respimat using FEV1 AUC values [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- ECG [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- The key secondary objective will be to compare once daily treatment with 5 mcg or 10 mcg BI 1744 administered via the Respimat device is superior to twice daily treatment with Foradil Aerolizer using FEV1 AUC values. [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
- Additional endpoints of FEV1, FVC, FEV1 AUC [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
- Adverse Events [ Time Frame: 6 Weeks ] [ Designated as safety issue: Yes ]
- Vital Signs [ Time Frame: 6 Weeks ] [ Designated as safety issue: Yes ]
- Clinical Chemistry [ Time Frame: 6 Weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 100 |
| Study Start Date: | June 2009 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BI1744 (Olodaterol)
Medium Dose once Daily
|
Drug: BI 1744 (Olodaterol) Medium Dose
BI1744 Respimat medium dose once daily and placebo Foradil
|
|
Experimental: BI 1744 (Olodaterol)
Low Dose once Daily
|
Drug: BI 1744 (Olodaterol) Low Dose
BI1744 Respimat low dose once daily and placebo Foradil
|
|
Placebo Comparator: Placebo
Placebo once Daily
|
Drug: Placebo
Placebo Respimat once daily and placebo Foradil
|
|
Active Comparator: Foradil
12 mcg twice daily
|
Drug: Foradil
12 mcg twice daily and placebo Respimat
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients willing to participate with confirmed diagnosis of COPD
- 40 years of age or older
- having a 10 pack year smoking history
- able to perform serial pulmonary function tests
- able to use both a DPI and Respimat device
Exclusion Criteria:
Significant other disease
- clinically relevant abnormal hematology, chemistry, or urinalysis
- history of asthma
- diagnosis of thyrotoxicosis
- paroxysmal tachycardia related to beta agonists
- history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure within 1 year
- active tuberculosis, cystic fibrosis, clinically evident bronchiectasis
- significant alcohol or drug use
- pulmonary resection
- taking oral beta adrenergics
- taking unstable oral steroids
- daytime oxygen
- enrolled in rehabilitation program
- enrolled in another study or taking investigational products
- pregnant or nursing women, women of child bearing potential not willing to use two methods of birth control
- those who are not willing to comply with pulmonary medication washouts
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932646
Locations
| United States, Alabama | |
| 1222.25.25009 Boehringer Ingelheim Investigational Site | |
| Jasper, Alabama, United States | |
| United States, Florida | |
| 1222.25.25002 Boehringer Ingelheim Investigational Site | |
| Clearwater, Florida, United States | |
| 1222.25.25003 Boehringer Ingelheim Investigational Site | |
| Deland, Florida, United States | |
| 1222.25.25007 Boehringer Ingelheim Investigational Site | |
| Winter Park, Florida, United States | |
| United States, Georgia | |
| 1222.25.25010 Boehringer Ingelheim Investigational Site | |
| Austell, Georgia, United States | |
| United States, New Mexico | |
| 1222.25.25008 Boehringer Ingelheim Investigational Site | |
| Albuquerque, New Mexico, United States | |
| United States, North Carolina | |
| 1222.25.25012 Boehringer Ingelheim Investigational Site | |
| Charlotte, North Carolina, United States | |
| 1222.25.25004 Boehringer Ingelheim Investigational Site | |
| Raleigh, North Carolina, United States | |
| United States, Ohio | |
| 1222.25.25011 Boehringer Ingelheim Investigational Site | |
| Columbus, Ohio, United States | |
| United States, South Carolina | |
| 1222.25.25014 Boehringer Ingelheim Investigational Site | |
| Seneca, South Carolina, United States | |
| United States, Tennessee | |
| 1222.25.25006 Boehringer Ingelheim Investigational Site | |
| Knoxville, Tennessee, United States | |
| United States, Texas | |
| 1222.25.25005 Boehringer Ingelheim Investigational Site | |
| Houston, Texas, United States | |
| United States, Virginia | |
| 1222.25.25013 Boehringer Ingelheim Investigational Site | |
| Richmond, Virginia, United States | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00932646 History of Changes |
| Other Study ID Numbers: | 1222.25 |
| Study First Received: | July 2, 2009 |
| Last Updated: | November 15, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases Formoterol Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013