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Study in Patients With COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00215423
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : November 11, 2010
Sponsor:
Information provided by:
Dey

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date November 11, 2010
Study Start Date  ICMJE Not Provided
Actual Primary Completion Date December 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
Measure of lung function
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00215423 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
  • Change in lung function, as well as vital signs
  • Physical Exam results, adverse event reporting, etc
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study in Patients With COPD
Official Title  ICMJE Not Provided
Brief Summary The purpose of this study is to determine which dose of the investigational drug is the most safe and effective for the treatment of COPD compared to the control drug
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • COPD
  • Chronic Obstructive Pulmonary Disease
Intervention  ICMJE Drug: Formoterol Fumarate
Study Arms  ICMJE Not Provided
Publications * Gross NJ, Kerwin E, Levine B, Kim KT, Denis-Mize K, Hamzavi M, Carpenter M, Rinehart M. Nebulized formoterol fumarate: Dose selection and pharmacokinetics. Pulm Pharmacol Ther. 2008 Oct;21(5):818-23. doi: 10.1016/j.pupt.2008.07.002. Epub 2008 Jul 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 14, 2005)
49
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2005
Actual Primary Completion Date December 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of COPD
  • History of cigarette smoking

Exclusion Criteria:

  • Clinical diagnosis of asthma
  • Significant pulmonary disease other than COPD
  • Other significant major organ disease(s)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00215423
Other Study ID Numbers  ICMJE DL-057
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Affairs, Dey
Study Sponsor  ICMJE Dey
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Dey
Verification Date August 2008

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