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The Effectiveness of Roflumilast in Improving Mucociliary Clearance in Patients With COPD and Chronic Bronchitis

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: NCT03073798
Recruitment Status : Completed
First Posted : March 8, 2017
Results First Posted : July 27, 2017
Last Update Posted : July 27, 2017
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: COPD
Chronic Bronchitis
Interventions: Drug: Roflumilast
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
All Participants Subjects underwent baseline MCC, then first received Roflumilast 500 mcg daily for 4 weeks. After a washout period of 4 weeks, they then received Placebo 500 mcg for an additional 4 weeks.

Participant Flow:   Overall Study
    All Participants
Adverse Event                1 
Withdrawal by Subject                1 

  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.
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Reporting Groups
All Participants

Roflumilast. 500 mcg of Roflumilast daily for 4 weeks, then there will be a 4 week wash-out phase (no medication) and a second 4 week period of placebo.

Roflumilast: 500 mcg of Roflumilast which is a prescription medicine used in adults with severe Chronic Obstructive Pulmonary Disease (COPD) to decrease the number of flare-ups or the worsening of COPD symptoms

Placebo: 500 mcg of placebo is used

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      1   8.3% 
>=65 years      11  91.7% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      5  41.7% 
Male      7  58.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
American Indian or Alaska Native      1   8.3% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      2  16.7% 
White      9  75.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 

  Outcome Measures

1.  Primary:   Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A   [ Time Frame: Change from 0 to 30 minutes ]

2.  Primary:   Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A   [ Time Frame: Change from 0 to 60 minutes ]

3.  Primary:   Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A   [ Time Frame: Change from 0 to 90 minutes ]

4.  Primary:   Difference in Mucociliary Clearance (MCC) Between Visit 1B and Visit 2B   [ Time Frame: Change from 0 min to 24 hours ]

  Serious Adverse Events

  Other Adverse Events

  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
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Nadia N Hansel, MD MPH
Organization: Johns Hopkins University
phone: 410-550-2935
e-mail: nhansel@jhmi.edu

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03073798     History of Changes
Other Study ID Numbers: NA_00078710
First Submitted: March 2, 2017
First Posted: March 8, 2017
Results First Submitted: June 29, 2017
Results First Posted: July 27, 2017
Last Update Posted: July 27, 2017