A 6-Week Trial to Compare the Efficacy and Safety of Concomitant Treatment With Formoterol Fumarate Inhalation Solution 20 Mcg Twice Daily and Tiotropium 18 Mcg Once Daily to Tiotropium 18 Mcg Once Daily Alone in the Treatment of Patients With Chronic Obstructive Pulmonary Disease

Dey1 site in 1 country128 target enrollmentMarch 2007

ConditionsChronic Obstructive Pulmonary Disease

Drugsformoterol fumarate inhalation solution

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Dey
Enrollment: 128
Locations: 1
Primary Endpoint: The primary efficacy endpoint will be the standardized area under the curve for FEV1 (FEV1 AUC0-3) over the 3-hour assessment period at End Study (Week 6/ET).
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, Phase IIIb, randomized, double-blind, active-controlled, parallel-group, comparative study.

The objectives of this study are:

To compare the efficacy of tiotropium 18 mcg once daily plus Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg twice daily to tiotropium 18 mcg once daily.
To obtain safety data on the use of tiotropium 18 mcg once daily plus FFIS 20 mcg twice daily compared to tiotropium 18 mcg once daily.

Registry

clinicaltrials.gov

Start Date

March 2007

End Date

April 2008

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dey

Eligibility Criteria

Inclusion Criteria

•Medical diagnosis of COPD
•Current or prior history of cigarette smoking

Exclusion Criteria

•Medical diagnosis of asthma
•Significant condition or disease other than COPD

Outcomes

Primary Outcomes

The primary efficacy endpoint will be the standardized area under the curve for FEV1 (FEV1 AUC0-3) over the 3-hour assessment period at End Study (Week 6/ET).

Time Frame: 6 weeks