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

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).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00274534

Enrollment

Registered

2006-01-11

Start date

2000-12-31

Completion date

2003-07-31

Last updated

2013-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Brief summary

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

Interventions

DRUGTiotropium

DRUGSalmeterol

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Design outcomes

Primary

Measure	Time frame
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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026