Can an extra inhaler boost lung clearance in cystic fibrosis patients already on breakthrough drugs?
NCT ID NCT05740618
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether adding an inhaled medication called Bronchitol (mannitol) can further improve mucus clearance in people with cystic fibrosis who have moderate to severe lung disease and are already taking a triple-combination drug (elexacaftor/tezacaftor/ivacaftor). Fourteen adults participated, and researchers measured how quickly radioactive particles cleared from the lungs over one hour. The goal was to see if combining these treatments provides extra benefit beyond the modulator alone.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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14 people
The number who actually took part.
- Started
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Mar 2023
- Finished
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Jan 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Able to provide informed consent * Age ≥ 18 at the time of screening * Diagnosis of cystic fibrosis (CF) * Regularly using elexacaftor/tezacaftor/ivacaftor (E/T/I) for ≥ 90 days * Forced Expiratory Volume in one second (FEV1) between 30% and 70%, inclusive, at time of screening * Denies active smoking or vaping * Clinically stable with no significant changes in health status within the 28 days prior to and including the screening visit * Patients on cycled inhaled antibiotics will need to be either on or off their antibiotic for 7 days prior to Visit 1 and not scheduled to cycle during the 2-week treatment period until after Visit 2 * Has no other conditions that, in the opinion of the Site Investigator/Designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives Exclusion Criteria: * Use of an investigational drug within 28 days prior to and including the screening visit * Unable or unwilling to withhold hypertonic saline (HS) for 4 weeks (2 weeks prior to Visit 1 and 2 weeks between Visit 1 and Visit 2) * Unable or willing to withhold dornase alfa and bronchodilators on the morning of Visit 1 and Visit 2, until completion of study procedures * Initiation of new chronic CF pulmonary therapy (e.g. dornase alfa, azithromycin, inhaled antibiotic) within 28 days prior to and including the screening visit * No acute use of antibiotics (oral, inhaled, or intravenous) or acute use of systemic corticosteroids for respiratory tract symptoms within 28 days prior to and including the screening visit. * No chronic use of oral corticosteroids \> 10 mg of prednisone or equivalent daily * Unable to tolerate albuterol or other bronchodilator * History of intolerance to HS or inhaled mannitol * Pregnancy or breast feeding * Have had more than 2 chest computed tomography (CT) in the past year or a combination of procedures that are believed to have exposed the subject's lungs to \>150 millisievert (mSv) * History of significant hemoptysis (\>60 mL) in the last three months
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
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