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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.
Information provided by:
Boehringer Ingelheim Identifier:
First received: January 9, 2006
Last updated: November 4, 2013
Last verified: November 2013
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

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00274534

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
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information Identifier: NCT00274534     History of Changes
Other Study ID Numbers: 205.234
Study First Received: January 9, 2006
Last Updated: November 4, 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
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents processed this record on August 18, 2017