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A Comparison of the Effects of Tiotropium Inhalation qd and Salmeterol Inhalation Bid on Arterial Blood Gases.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00274534
First Posted: January 11, 2006
Last Update Posted: November 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boehringer Ingelheim
  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
Primary Purpose: Treatment
Official Title: A Comparison of the Effects of Tiotropium (18 Mcg) Inhalation Capsule q.d. and Salmeterol (50 Mcg) Inhalation Aerosol b.i.d. on Arterial Blood Gases in a Double-blind, Double-dummy, 4-week Crossover Study in Patients With Chronic Obstructive Pulmonary Disease (COPD).

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • The change from baseline (Visit 2) in the PaO2 area under the curve (AUC) for the time period 0 to 105 minutes obtained through arterial blood gases (ABGs) at the end of each treatment period. [ Time Frame: up to day 90 ]

Secondary Outcome Measures:
  • Maximum decline in PaO2 from baseline [ Time Frame: up to day 90 ]
  • Maximum increase in alveolar-arterial oxygen gradient from baseline [ Time Frame: up to day 90 ]
  • Change from baseline (Visit 2) in FEV1 prior to insertion of catheter and 15 minutes post removal of catheter [ Time Frame: up to day 90 ]
  • Change from baseline (Visit 2) in FVC prior to insertion of catheter and 15 minutes post removal of catheter [ Time Frame: up to day 90 ]
  • Rescue medication use [ Time Frame: up to day 90 ]
  • COPD symptom score [ Time Frame: up to day 90 ]
  • Occurrence of adverse events [ Time Frame: up to day 90 ]
  • Pulse rate and sitting blood pressure in conjunction with spirometry [ Time Frame: up to day 90 ]

Estimated Enrollment: 36
Study Start Date: December 2000
Estimated Study Completion Date: July 2003
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

ClinicalTrials.gov Identifier: NCT00274534     History of Changes
Other Study ID Numbers: 205.234
First Submitted: January 9, 2006
First Posted: January 11, 2006
Last Update Posted: November 5, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Aspiration
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiration Disorders
Pathologic Processes
Disease Attributes
Tiotropium Bromide
Salmeterol Xinafoate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents