A Phase IIIB Study to Compare the Efficacy and Safety of Concomitant Treatment in Patients With COPD

A 6-Week Double-Blind, Parallel-Group, Active-Controlled Trial to Compare the Efficacy and Safety of Concomitant Treatment of 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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00308191

Enrollment

128

Registered

2006-03-29

Start date

2006-04-30

Completion date

2006-12-31

Last updated

2008-03-07

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

Conditions

COPD

Keywords

COPD, Formoterol, Tiotropium

Brief summary

The purpose of this study is to evaluate the safety and efficacy of the concomitant treatment of formoterol fumarate with tiotropium bromide compared to treatment with tiotropium bromide alone.

Interventions

DRUGFormoterol Fumarate

DRUGTiotropium Bromide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Measure of lung Function	—

Secondary

Measure	Time frame
Change in lung function, vital signs; physical examinations; clinical laboratory assessments; adverse event reporting; patient questionnaires	—

Countries

United States

Outcome results

None listed

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