Trial · NCT03073798
The Effectiveness of Roflumilast in Improving Mucociliary Clearance in Patients With COPD and Chronic Bronchitis
NCT03073798, Phase 4, Completed, Johns Hopkins University; results first posted 2017-07-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Effectiveness of Roflumilast in Improving Mucociliary Clearance in Patients With COPD and Chronic Bronchitis. Trials, record NCT03073798. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03073798
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effectiveness of Roflumilast in Improving Mucociliary Clearance in Patients With COPD and Chronic Bronchitis
- NCT number
- NCT03073798
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 12 participants, actual
- Lead sponsor
- Johns Hopkins University
- Conditions
- COPD, Chronic Bronchitis, Emphysema
- Interventions
- Roflumilast, Placebo
- First posted
- 2017-03-08
- Last updated
- 2017-07-27
- Results first posted
- 2017-07-27
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A | Change from 0 to 30 minutes | 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. |
| Primary | Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A | Change from 0 to 60 minutes | 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. |
| Primary | Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A | Change from 0 to 90 minutes | 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. |
| Primary | Difference in Mucociliary Clearance (MCC) Between Visit 1B and Visit 2B | Change from 0 min to 24 hours | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A | Change from 0 to 30 minutes | 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. | percentage difference of MCC | MEAN |
| PRIMARY | Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A | Change from 0 to 60 minutes | 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. | percentage difference of MCC | MEAN |
| PRIMARY | Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A | Change from 0 to 90 minutes | 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. | percentage difference of MCC | MEAN |
| PRIMARY | Difference in Mucociliary Clearance (MCC) Between Visit 1B and Visit 2B | Change from 0 min to 24 hours | 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. | percentage difference of MCC | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A | All Roflumilast MCC | -1.50 | Standard Deviation 3.76 | percentage difference of MCC | |
| Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A | All Placebo MCC | -0.70 | Standard Deviation 4.71 | percentage difference of MCC | |
| Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A | All Roflumilast MCC | -2.18 | Standard Deviation 5.17 | percentage difference of MCC | |
| Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A | All Placebo MCC | 0.13 | Standard Deviation 5.81 | percentage difference of MCC | |
| Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A | All Roflumilast MCC | -1.31 | Standard Deviation 7.77 | percentage difference of MCC | |
| Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A | All Placebo MCC | 0.52 | Standard Deviation 6.63 | percentage difference of MCC | |
| Difference in Mucociliary Clearance (MCC) Between Visit 1B and Visit 2B | All Roflumilast MCC | -0.13 | Standard Deviation 12.87 | percentage difference of MCC | |
| Difference in Mucociliary Clearance (MCC) Between Visit 1B and Visit 2B | All Placebo MCC | 6.93 | Standard Deviation 18.50 | percentage difference of MCC |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Participants | 12 | |
| Overall Study | COMPLETED | All Participants | 10 | |
| Overall Study | NOT COMPLETED | All Participants | 2 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Pulmonary Exacerbation | Respiratory, thoracic and mediastinal disorders | All Participants | 1 | 12 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | 0 | 12 |
| Total, other adverse events | All Participants | 0 | 12 |
| Total, serious adverse events | All Participants | 1 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03073798
GET https://conductscience.org/api/trials/v1/NCT03073798/registered