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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00274534
First received: January 9, 2006
Last updated: November 4, 2013
Last verified: November 2013
  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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum decline in PaO2 from baseline [ Time Frame: up to day 90 ] [ Designated as safety issue: No ]
  • Maximum increase in alveolar-arterial oxygen gradient from baseline [ Time Frame: up to day 90 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Rescue medication use [ Time Frame: up to day 90 ] [ Designated as safety issue: No ]
  • COPD symptom score [ Time Frame: up to day 90 ] [ Designated as safety issue: No ]
  • Occurrence of adverse events [ Time Frame: up to day 90 ] [ Designated as safety issue: No ]
  • Pulse rate and sitting blood pressure in conjunction with spirometry [ Time Frame: up to day 90 ] [ Designated as safety issue: No ]

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
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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
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  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: November 4, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 30, 2014