A Crossover Study in the Treatment of Patients With COPD

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00462540

Enrollment

100

Registered

2007-04-19

Start date

2007-05-31

Completion date

2007-10-31

Last updated

2009-03-04

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, Formoterol, Ipratropium, Crossover

Brief summary

The purpose of this study is to compare the efficacy of Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg BID to Combivent® Inhalation Aerosol \[2 inhalations from metered dose inhaler (MDI)of 18 mcg ipratropium bromide and 103 mcg albuterol sulfate QID\], and to Compare the preference/compliance of BID nebulization to QID use of MDI

Interventions

DRUGFormoterol Fumurate inhalation solution 20 mcg

DRUGIpratropium bromide 18 mcg and albuterol sulfate 103 mcg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of COPD * Smoker or exsmoker with at least 10 years smoking at least one pack of cigarettes per day * Meet lung function requirements

Exclusion criteria

* Diagnosis of Asthma * Significant disease other than COPD * Female pregnant or lactating or planning to become pregnant

Design outcomes

Primary

Measure	Time frame
Lung function after 2 weeks of treatment	—

Secondary

Measure	Time frame
Lung function at each time point, patient questionnaires, medication compliance,	—
adverse events, clinical labs, vital signs, ECGs, physical exams	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026