Trial · NCT05740618
Inhaled Mannitol on Mucociliary Clearance in Moderate to Severe Cystic Fibrosis
NCT05740618, Phase 4, Completed, University of North Carolina, Chapel Hill; results first posted 2026-01-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Inhaled Mannitol on Mucociliary Clearance in Moderate to Severe Cystic Fibrosis. Trials, record NCT05740618. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05740618
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Inhaled Mannitol on Mucociliary Clearance in Moderate to Severe Cystic Fibrosis
- NCT number
- NCT05740618
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 14 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Cystic Fibrosis
- Interventions
- Mannitol Inhalant Product
- First posted
- 2023-02-23
- Last updated
- 2026-01-07
- Results first posted
- 2026-01-07
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Rate of Mucociliary Clearance (MCC) Over 60 Minutes | Day 14 (+/-2 days) | A whole lung region of interest (ROI) bordering the right lung is used to estimate (by computer analysis) whole lung retention of inhaled radiolabeled particles. Labeled particle counts are measured over a 60-minute period to determine the fraction of initial particle counts remaining. From this data, the investigators will determine the percentage of labeled particles cleared from the lung during the 60-minute observation period. The primary outcome will be expressed as a percent, representing total average rate of mucociliary clearance (MCC) in the whole right lung compartment over 60 minutes (MCC60). |
| Secondary | Cough Clearance | Day 14 (+/-2 days) | Subjects will cough a total of 30 times over a 30-minute period to assess cough clearance by gamma imaging over that period. Clearance will be determined by measuring the decrease in radiolabeled Tc99m-sulfur colloid in the lungs over time expressed as a percent cleared. |
| Secondary | Rate of Mucociliary Clearance (MCC) Over 90 Minutes | Day 14(+/-2 days) | A whole lung region of interest (ROI) bordering the right lung is used to estimate (by computer analysis) whole lung retention of inhaled radiolabeled particles. Labeled particle counts are measured over a 90-minute period to determine the fraction of initial particle counts remaining. From this data, the investigators will determine the percentage of labeled particles cleared from the lung during the 90-minute observation period. The primary outcome will be expressed as a percent, representing total average rate of mucociliary clearance (MCC) in the whole right lung compartment over 90 minutes (MCC90). |
| Secondary | Forced Expiratory Volume in One Second (FEV1) Percent of Predicted | Day 14 (+/-2 days) | FEV1 is measured by spirometry. On each occasion, the best of 3 trials, based on American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria. The best FEV1 (from trial with highest sum of FEV1 and Forced Vital Capacity (FVC)) will be recorded and reported as percent of predicted. |
| Secondary | Respiratory Symptoms as Measured by the Cystic Fibrosis Respiratory Questionnaire Revised (CFQR-R) | Day 14(+/-2 days) | The CFQ-R (Cystic fibrosis Questionnaire - Revised) is a detailed, rigorously designed and validated self-report instrument designed to measure quality of life in patients with CF who are 14 years and older. This instrument was developed as the first CF-specific, health-related Quality of Life (QOL) measure. The respiratory domain has a 0-100 scale, with higher values signifying less severe symptoms. |
| Secondary | Respiratory Symptoms as Measured by the Cystic Fibrosis Respiratory Symptom Diary and Chronic Respiratory Infection Symptom Score (CFRSD-CRISS) | Day 14(+/-2 days) | The CFRSD-CRISS is an 8-item, patient-centered, self-report outcome measure evaluating symptom severity over the prior 24 hours in 8 domains central to CF. Each question is assigned a score from 0-4 based on the response, with zero reflecting the absence of the symptom and four reflecting that the symptoms is present 'a great deal' or 'extremely'. A summed score (range from 0-24) is converted to a 0-100 scale, where lower scores indicate fewer symptoms. |
| Secondary | Respiratory Symptoms as Measured by the Treatment Satisfaction Questionnaire Measure (TSQM) | Day 14(+/-2 days) | The TSQM is a 14-question standardize measure for assessment of self-reported treatment satisfaction and has been valued for use of inhaled medications in people with CF. The TSQM items are answered on 5- or 7-point Likert type scale and cover four domains, corresponding to distinct aspects related to the satisfaction of patients with their treatment (Effectiveness; Side effects; Convenience and Global satisfaction). The questionnaire is scored on a 0-100 scale, with higher values indicated greater satisfaction. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Rate of Mucociliary Clearance (MCC) Over 60 Minutes | Day 14 (+/-2 days) | percent cleared over 60 minutes | MEAN | |
| SECONDARY | Cough Clearance | Day 14 (+/-2 days) | percent cleared over 30 minutes | MEAN | |
| SECONDARY | Rate of Mucociliary Clearance (MCC) Over 90 Minutes | Day 14(+/-2 days) | percent cleared over 90 minutes | MEAN | |
| SECONDARY | Forced Expiratory Volume in One Second (FEV1) Percent of Predicted | Day 14 (+/-2 days) | percent predicted | MEAN | |
| SECONDARY | Respiratory Symptoms as Measured by the Cystic Fibrosis Respiratory Questionnaire Revised (CFQR-R) | Day 14(+/-2 days) | score on a scale | MEAN | |
| SECONDARY | Respiratory Symptoms as Measured by the Cystic Fibrosis Respiratory Symptom Diary and Chronic Respiratory Infection Symptom Score (CFRSD-CRISS) | Day 14(+/-2 days) | score on a scale | MEAN | |
| SECONDARY | Respiratory Symptoms as Measured by the Treatment Satisfaction Questionnaire Measure (TSQM) | Day 14(+/-2 days) | While participants completed the questionnaire, we are unable to generate a reportable result. As we learned late in the process, the scoring manual required to code responses and calculate results is proprietary, and the rights for its use were not secured. This data will never be analyzed in the future. The study protocol was not amended to reflect this change. |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Rate of Mucociliary Clearance (MCC) Over 60 Minutes | Inhaled Mannitol | 14.8 | Standard Deviation 6.5 | percent cleared over 60 minutes | |
| Cough Clearance | Inhaled Mannitol | 0.30 | Standard Deviation 0.06 | percent cleared over 30 minutes | |
| Rate of Mucociliary Clearance (MCC) Over 90 Minutes | Inhaled Mannitol | 18.2 | Standard Deviation 7.7 | percent cleared over 90 minutes | |
| Forced Expiratory Volume in One Second (FEV1) Percent of Predicted | Inhaled Mannitol | 46.9 | Standard Deviation 11.3 | percent predicted | |
| Respiratory Symptoms as Measured by the Cystic Fibrosis Respiratory Questionnaire Revised (CFQR-R) | Inhaled Mannitol | 78.3 | Standard Deviation 13.7 | score on a scale | |
| Respiratory Symptoms as Measured by the Cystic Fibrosis Respiratory Symptom Diary and Chronic Respiratory Infection Symptom Score (CFRSD-CRISS) | Inhaled Mannitol | 33.3 | Standard Deviation 7.2 | score on a scale |
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 | Inhaled Mannitol | 14 | |
| Overall Study | COMPLETED | Inhaled Mannitol | 12 | |
| Overall Study | NOT COMPLETED | Inhaled Mannitol | 2 |
Source ClinicalTrials.gov
Adverse events3
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 |
|---|---|---|---|---|---|---|
| other | Inhaled mannitol intolerance as demonstrated by FEV1 decline | Respiratory, thoracic and mediastinal disorders | Inhaled Mannitol | 1 | 13 | 1 |
| other | Lightheadedness | Nervous system disorders | Inhaled Mannitol | 1 | 13 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Inhaled Mannitol | 1 | 13 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Inhaled Mannitol | 0 | 13 |
| Total, other adverse events | Inhaled Mannitol | 3 | 13 |
| Total, serious adverse events | Inhaled Mannitol | 0 | 13 |
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/NCT05740618
GET https://conductscience.org/api/trials/v1/NCT05740618/registered