A Comparison of the Effects of Tiotropium Inhalation qd and Salmeterol Inhalation Bid on Arterial Blood Gases.
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00274534
First received: January 9, 2006
Last updated: May 11, 2012
Last verified: May 2012
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Purpose
To evaluate changes in PaO2 following inhalation of Tiotropium by HandiHaler compared to Salmeterol MDI in patients with moderate to severe COPD.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: Tiotropium Drug: Salmeterol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol in a 12 Week, Randomized, Double-Blind, Double-Dummy Parallel Group Study in Patients With Chronic Obstructive Pulmonary Disease (COPD). |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- The primary ctiterion for evaluation is change from baseline (Visit 2) in the PaO2 AUC for the time period 0 to105 min. obtained through ABGs at the end of each treatment period in patients with COPD.
Secondary Outcome Measures:
- Maximum decline in PaO2 from (Visit 2) will be compared between treatment groups. PaO2. Maximum increase in alveolar-arterial oxygen gradient from Visit 2. Change from baseline (visit 2) FEV1 and FVC.
| Estimated Enrollment: | 36 |
| Study Start Date: | December 2000 |
| Estimated Study Completion Date: | July 2003 |
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274534
Locations
| United States, Illinois | |
| Hines Veterans Administration Hospital | |
| Hines, Illinois, United States | |
| United States, Virginia | |
| Hunter Holmes McGuire Medical Center | |
| Richmond, Virginia, United States | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00274534 History of Changes |
| Other Study ID Numbers: | 205.234 |
| Study First Received: | January 9, 2006 |
| Last Updated: | May 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Respiratory Aspiration Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Disease Attributes Pathologic Processes Salmeterol Tiotropium 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 Parasympatholytics Cholinergic Antagonists Cholinergic Agents |
ClinicalTrials.gov processed this record on May 22, 2013