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

November 4, 2013 updated by: Boehringer Ingelheim

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).

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

Study Overview

Status

Completed

Conditions

Pulmonary Disease, Chronic Obstructive

Intervention / Treatment

Study Type

Interventional

Enrollment

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Illinois
  - Hines, Illinois, United States
    - Hines Veterans Administration Hospital
- Virginia
  - Richmond, Virginia, United States
    - Hunter Holmes McGuire Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome 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. Time Frame: up to day 90	up to day 90

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum decline in PaO2 from baseline Time Frame: up to day 90	up to day 90
Maximum increase in alveolar-arterial oxygen gradient from baseline Time Frame: up to day 90	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	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	up to day 90
Rescue medication use Time Frame: up to day 90	up to day 90
COPD symptom score Time Frame: up to day 90	up to day 90
Occurrence of adverse events Time Frame: up to day 90	up to day 90
Pulse rate and sitting blood pressure in conjunction with spirometry Time Frame: up to day 90	up to day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Study Completion

July 1, 2003

Study Registration Dates

First Submitted

January 9, 2006

First Submitted That Met QC Criteria