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A Trial to Assess the Pharmacodynamic Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dey
ClinicalTrials.gov Identifier:
NCT01168310
First received: July 21, 2010
Last updated: May 17, 2013
Last verified: May 2013

July 21, 2010
May 17, 2013
August 2010
August 2010   (final data collection date for primary outcome measure)
Change in forced expiratory volume at one second (FEV1) measured in milliliters by spirometry to assess pharmacodynamic response of fluticasone propionate in combination with formoterol fumarate in subject with COPD [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
Change in FEV1 measured in milliliters by spirometry to assess pharmacodynamic response of fluticasone propionate in combination with formoterol fumarate in subject with COPD [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01168310 on ClinicalTrials.gov Archive Site
Incidence of adverse events (AEs) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Trial to Assess the Pharmacodynamic Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A 12-week Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Pharmacodynamic Response of Fluticasone Propionate in Fixed-Dose Combination With Formoterol Fumarate in Subjects With COPD

This is a randomized, double-blind, multi-dose, parallel group trial which will assess the pharmacodynamic response of fluticasone propionate and formoterol fumarate in subjects with COPD.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: Fluticasone Propionate/Formoterol Fumarate
    Inhalation Suspension
  • Drug: Formoterol Fumarate
    Inhalation Solution
  • Drug: Placebo
    Inhalation Solution
  • Experimental: 1
    Intervention: Drug: Fluticasone Propionate/Formoterol Fumarate
  • Experimental: 2
    Intervention: Drug: Fluticasone Propionate/Formoterol Fumarate
  • Experimental: 3
    Intervention: Drug: Fluticasone Propionate/Formoterol Fumarate
  • Experimental: 4
    Intervention: Drug: Fluticasone Propionate/Formoterol Fumarate
  • Experimental: 5
    Intervention: Drug: Fluticasone Propionate/Formoterol Fumarate
  • Active Comparator: 6
    Intervention: Drug: Formoterol Fumarate
  • Placebo Comparator: 7
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
468
October 2011
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Able to understand the requirements of the study and provide written informed consent
  • A clinical diagnosis of COPD
  • A current or prior history of at least 10-pack years of cigarette smoking
  • Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the screening visit and agree to avoid becoming pregnant for the duration of study

Exclusion Criteria:

  • A clinical diagnosis of Asthma
  • Other significant disease than COPD
  • Subjects who radiation or chemotherapy within the previous 12 months
  • Subjects who had any lung resection
  • QTcB greater than 0.460 seconds
  • History of illegal drug abuse or alcohol abuse within the past 5 years
Both
40 Days and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01168310
191-090
No
Dey
Dey
Not Provided
Not Provided
Dey
May 2013

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