Expired Study
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Huntington Beach, California 92647


Purpose:

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


Criteria:

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


Study is Available At:


Original ID:

201-065


NCT ID:

NCT00215436


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

40 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Dey


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

345


Enrollment Type:


Study Dates

Start Date:March 2005
Completion Date:September 2006
Completion Type:Actual
Primary Completion Date:September 2005
Primary Completion Type:Actual
Verification Date:April 2008
Last Changed Date:November 9, 2010
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Physical Exam results, Adverse event reporting, etc
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in lung function, as well as vital signs
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Measure of lung function
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Formoterol Fumarate

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Dey

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Gross NJ, Nelson HS, Lapidus RJ, Dunn L, Lynn L, Rinehart M, Denis-Mize K; Formoterol Study Group. Efficacy and safety of formoterol fumarate delivered by nebulization to COPD patients. Respir Med. 2008 Feb;102(2):189-97.
PMID:18363201
Reference Type:Results Reference
Citation:Nelson HS, Gross NJ, Levine B, Kerwin EM, Rinehart M, Denis-Mize K, Formoterol Study Group. Cardiac safety profile of nebulized formoterol in adults with COPD: a 12-week, multicenter, randomized, double- blind, double-dummy, placebo- and active-controlled trial. Clin Ther. 2007 Oct;29(10):2167-78.
PMID:18042473

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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