Trial Outcomes & Findings for The Effectiveness of Roflumilast in Improving Mucociliary Clearance in Patients With COPD and Chronic Bronchitis (NCT NCT03073798)

Last Updated: 2017-07-27

Results Overview

Measurements of MCC (Mucociliary clearance) will be obtained using a large-field-of-view 2D gamma camera (Siemens Orbiter) following inhalation of a radioaerosol containing a gamma emitting isotope 99mtechnetium (99mTc)-sulfur-colloid. The total exposure to radiation from procedures associated with the MCC studies is similar to that of a chest x-ray and is much less than the 0.3 rem that the average person in the United States gets each year from natural sources like the sun, outer space, air, food, and soil. After inhaling (0 time point) an aerosol generated from a saline solution containing the radioisotope 99mtechnetium (99mTc)-sulfur-colloid (radioaerosol), subjects will sit with their back to a gamma camera. The gamma camera will acquire an image of where the isotopic marker initially deposits in the right lung at time 0 and how much remains in the lungs at the specified time point and will be measured in change of %/min from 0 min time point.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

Change from 0 to 30 minutes

Results posted on

2017-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	12
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=12 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change from 0 to 30 minutes

Population: Data was not collected for all participants in this outcome measure due to lack of follow-up, patient withdrawal from the study, and an adverse event.

Outcome measures

Outcome measures
Measure	All Roflumilast MCC n=9 Participants Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on roflumilast.	All Placebo MCC n=10 Participants Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on placebo.
Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A	-1.50 percentage difference of MCC Standard Deviation 3.76	-0.70 percentage difference of MCC Standard Deviation 4.71

PRIMARY outcome

Timeframe: Change from 0 to 60 minutes

Population: Data was not collected for all participants in this outcome measure due to lack of follow-up, patient withdrawal from the study, and an adverse event.

Outcome measures

Outcome measures
Measure	All Roflumilast MCC n=9 Participants Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on roflumilast.	All Placebo MCC n=10 Participants Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on placebo.
Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A	-2.18 percentage difference of MCC Standard Deviation 5.17	0.13 percentage difference of MCC Standard Deviation 5.81

PRIMARY outcome

Timeframe: Change from 0 to 90 minutes

Population: Data was not collected for all participants in this outcome measure due to lack of follow-up, patient withdrawal from the study, and an adverse event.

Outcome measures

Outcome measures
Measure	All Roflumilast MCC n=9 Participants Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on roflumilast.	All Placebo MCC n=10 Participants Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on placebo.
Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A	-1.31 percentage difference of MCC Standard Deviation 7.77	0.52 percentage difference of MCC Standard Deviation 6.63

PRIMARY outcome

Timeframe: Change from 0 min to 24 hours

Population: Data was not collected for all participants in this outcome measure due to lack of follow-up, patient withdrawal from the study, and an adverse event.

Outcome measures

Outcome measures
Measure	All Roflumilast MCC n=9 Participants Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on roflumilast.	All Placebo MCC n=10 Participants Taking into account the washout period and crossover design of this study, we are presenting the results to reflect all of the MCC studies done while the participants were on placebo.
Difference in Mucociliary Clearance (MCC) Between Visit 1B and Visit 2B	-0.13 percentage difference of MCC Standard Deviation 12.87	6.93 percentage difference of MCC Standard Deviation 18.50

Adverse Events

All Participants

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Participants n=12 participants at risk 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. MCC was conducted at baseline and at the end of each 4 week medication phase.
Respiratory, thoracic and mediastinal disorders Pulmonary Exacerbation	8.3% 1/12 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Nadia N Hansel, MD MPH

Johns Hopkins University

Phone: 410-550-2935

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place