A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate in the Treatment of Patients With COPD

A 12-week Double-Blind, Parallel-Group, Placebo- and Active- Controlled Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate Inhalation Solution 20 Mcg in the Treatment of Patients With Chronic Obstructive Pulmonary Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00215436

Enrollment

345

Registered

2005-09-22

Start date

2005-03-31

Completion date

2006-09-30

Last updated

2010-11-10

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

Conditions

COPD

Keywords

Chronic Obstructive Pulmonary Disease, COPD, formoterol

Brief summary

The purpose of this study is to determine the safety and efficacy of the investigational drug in comparison with a placebo.

Interventions

DRUGFormoterol Fumarate

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 * Chest X-ray diagnostic of significant disease other than COPD * 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, as well as vital signs	—
Physical Exam results, Adverse event reporting, etc	—

Countries

United States

Outcome results

None listed

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