Back to resultsA Comparison of the Effects of Tiotropium Inhalation qd and Salmeterol Inhalation Bid on Arterial Blood Gases.
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tiotropium
Salmeterol
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Sites / Locations
- Hines Veterans Administration Hospital
- Hunter Holmes McGuire Medical Center
Outcomes
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.
Secondary Outcome Measures
Maximum decline in PaO2 from baseline
Maximum increase in alveolar-arterial oxygen gradient from baseline
Change from baseline (Visit 2) in FEV1 prior to insertion of catheter and 15 minutes post removal of catheter
Change from baseline (Visit 2) in FVC prior to insertion of catheter and 15 minutes post removal of catheter
Rescue medication use
COPD symptom score
Occurrence of adverse events
Pulse rate and sitting blood pressure in conjunction with spirometry
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00274534
Brief Title
A Comparison of the Effects of Tiotropium Inhalation qd and Salmeterol Inhalation Bid on Arterial Blood Gases.
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).
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
To evaluate changes in PaO2 following inhalation of Tiotropium by HandiHaler compared to Salmeterol MDI in patients with moderate to severe COPD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
36 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tiotropium
Intervention Type
Drug
Intervention Name(s)
Salmeterol
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Maximum decline in PaO2 from baseline
Time Frame
up to day 90
Title
Maximum increase in alveolar-arterial oxygen gradient from baseline
Time Frame
up to day 90
Title
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
Title
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
Title
Rescue medication use
Time Frame
up to day 90
Title
COPD symptom score
Time Frame
up to day 90
Title
Occurrence of adverse events
Time Frame
up to day 90
Title
Pulse rate and sitting blood pressure in conjunction with spirometry
Time Frame
up to day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
Hines Veterans Administration Hospital
City
Hines
State/Province
Illinois
Country
United States
Facility Name
Hunter Holmes McGuire Medical Center
City
Richmond
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.234.pdf
Description
Related Info
Learn more about this trial
A Comparison of the Effects of Tiotropium Inhalation qd and Salmeterol Inhalation Bid on Arterial Blood Gases.
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