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NCT00274534 Clinical Trial

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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00274534
Other study ID # 205.234
Secondary ID
Status Completed
Phase Phase 3
First received January 9, 2006
Last updated November 4, 2013
Start date December 2000
Est. completion date July 2003

Study information
Verified date November 2013
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To evaluate changes in PaO2 following inhalation of Tiotropium by HandiHaler compared to Salmeterol MDI in patients with moderate to severe COPD.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date July 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Tiotropium

• Salmeterol

Locations
Country Name City State
United States Hines Veterans Administration Hospital Hines Illinois
United States Hunter Holmes McGuire Medical Center Richmond Virginia

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. up to day 90 No
Secondary Maximum decline in PaO2 from baseline up to day 90 No
Secondary Maximum increase in alveolar-arterial oxygen gradient from baseline up to day 90 No
Secondary Change from baseline (Visit 2) in FEV1 prior to insertion of catheter and 15 minutes post removal of catheter up to day 90 No
Secondary Change from baseline (Visit 2) in FVC prior to insertion of catheter and 15 minutes post removal of catheter up to day 90 No
Secondary Rescue medication use up to day 90 No
Secondary COPD symptom score up to day 90 No
Secondary Occurrence of adverse events up to day 90 No
Secondary Pulse rate and sitting blood pressure in conjunction with spirometry up to day 90 No
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