High Dose Trial in COPD
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00128440
First received: August 9, 2005
Last updated: January 31, 2008
Last verified: January 2008
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Purpose
The primary objective of this study is to compare the efficacy and safety of 200 ?g and 400 ?g of BE A 2180 to tiotropium 5 ?g and placebo when each is delivered by the Respimat Inhaler once daily for four weeks in patients with Chronic Obstructive Pulmonary Disease (COPD).
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: BEA 2180 BR Drug: tiotropium |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Multiple-Dose, Double-Blind, Crossover Study to Compare the Efficacy and Safety of 200 ?g and 400 ?g of BEA 2180 BR to Tiotropium 5 ?g and Placebo When Each is Delivered by the Respimat? Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD) |
Resource links provided by NLM:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for:
Tiotropium bromide
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- The primary efficacy variable will be forced expiratory volume in one second (FEV1). The two primary endpoints will be trough FEV1 response and FEV1 AUC0-6h after four weeks of treatment.
Secondary Outcome Measures:
- Trough FVC (forced vital capacity) response after 4 weeks FEV1 and FVC peak response after 0 and 4 weeks FVC AUC0-6h after 0 and 4 weeks Individual FEV1 and FVC measurements at each time point
| Estimated Enrollment: | 75 |
| Estimated Study Completion Date: | June 2007 |
Eligibility| Ages Eligible for Study: | 40 Years to 84 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
- Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 >=30% and <= 60% of predicted normal and FEV1 <=70% of FVC at the baseline PFTs at Visit 1 (at both timepoints).
- All patients must have an increase in FEV1 of at least 12% from baseline (th e -10 minute measurement) 45 min after inhalation of 80 ?g Atrovent MDI.
- Male or female patients 40 years of age or older.
- Smoker or ex-smoker with a history of more than 10 pack years.
1. Patients with any other significant disease will be excluded. 2. Patients with a history of asthma or allergic rhinitis will be excluded.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00128440
Locations
| United States, California | |
| Boehringer Ingelheim Investigational Site | |
| Lakewood, California, United States | |
| United States, Colorado | |
| Boehringer Ingelheim Investigational Site | |
| Wheat Ridge, Colorado, United States | |
| United States, Florida | |
| Boehringer Ingelheim Investigational Site | |
| Pembroke Farms, Florida, United States | |
| United States, Idaho | |
| Boehringer Ingelheim Investigational Site | |
| Coeur d'Alene, Idaho, United States | |
| United States, Nevada | |
| Boehringer Ingelheim Investigational Site | |
| Reno, Nevada, United States | |
| United States, New York | |
| Boehringer Ingelheim Investigational Site | |
| Larchmont, New York, United States | |
| United States, North Carolina | |
| Boehringer Ingelheim Investigational Site | |
| Winston-Salem, North Carolina, United States | |
| United States, South Carolina | |
| Boehringer Ingelheim Investigational Site | |
| Charleston, South Carolina, United States | |
| United States, Texas | |
| Boehringer Ingelheim Investigational Site | |
| Harker Heights, Texas, United States | |
| Boehringer Ingelheim Investigational Site | |
| Houston, Texas, United States | |
| Boehringer Ingelheim Investigational Site | |
| San Antonio, Texas, United States | |
| United States, Virginia | |
| Boehringer Ingelheim Investigational Site | |
| Richmond, Virginia, United States | |
| United States, Washington | |
| Boehringer Ingelheim Investigational Site | |
| Tacoma, Washington, United States | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Investigator: | Boehringer Ingelheim Study Coordinator |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00128440 History of Changes |
| Other Study ID Numbers: | 1205.6 |
| Study First Received: | August 9, 2005 |
| Last Updated: | January 31, 2008 |
| Health Authority: | Unspecified |
Additional relevant MeSH terms:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases Tiotropium Parasympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013