Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Dey
ClinicalTrials.gov Identifier:
NCT00215436
First received: September 13, 2005
Last updated: November 9, 2010
Last verified: April 2008

September 13, 2005
November 9, 2010
March 2005
September 2005   (final data collection date for primary outcome measure)
Measure of lung function
Same as current
Complete list of historical versions of study NCT00215436 on ClinicalTrials.gov Archive Site
  • Change in lung function, as well as vital signs
  • Physical Exam results, Adverse event reporting, etc
Same as current
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
COPD
Drug: Formoterol Fumarate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
345
September 2006
September 2005   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00215436
201-065
Not Provided
Director Clinical Affairs, Dey L.P.
Dey
Not Provided
Not Provided
Dey
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP