A Placebo-controlled Trial of Daliresp on Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
J Edwin Blalock, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01572948
First received: April 4, 2012
Last updated: July 29, 2015
Last verified: July 2015
Results First Received: May 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: COPD
Interventions: Drug: roflumilast
Drug: placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from a single center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Roflumilast group randomized to 30 day supply of white tablet 500microgram
Placebo 500microgram white tablet

Participant Flow:   Overall Study
    Roflumilast     Placebo  
STARTED     11     16  
COMPLETED     10     15  
NOT COMPLETED     1     1  
Lost to Follow-up                 1                 0  
unable to contact                 0                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
Roflumilast roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
Total Total of all reporting groups

Baseline Measures
    Placebo     Roflumilast     Total  
Number of Participants  
[units: participants]
  16     11     27  
Age  
[units: years]
Mean (Full Range)
  61   (53 to 69)     62   (55 to 69)     61   (53 to 69)  
Gender  
[units: participants]
     
Female     6     4     10  
Male     10     7     17  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     4     4     8  
White     12     7     19  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     16     11     27  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline   [ Time Frame: baseline ]

2.  Primary:   Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization.   [ Time Frame: 1 month after baseline ]

3.  Primary:   Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization   [ Time Frame: 3 months after baseline ]

4.  Secondary:   Induced Sputum Neutrophil Counts   [ Time Frame: baseline ]

5.  Secondary:   Induced Sputum Neutrophil Counts   [ Time Frame: 3 months after baseline ]

6.  Secondary:   Induced Sputum Neutrophil Counts   [ Time Frame: 1 month ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
small sample size and limited follow-up


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: J. Michael Wells, M.D.
Organization: University of Alabama at Birmingham, Division of Pulmonary, Allergy, and Critical Care Medicine
phone: 205-934-6047
e-mail: jmwells@uab.edu


No publications provided


Responsible Party: J Edwin Blalock, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01572948     History of Changes
Other Study ID Numbers: DAL-MD-01
Study First Received: April 4, 2012
Results First Received: May 29, 2015
Last Updated: July 29, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board