By InvitationNot Applicable

Clean Air for Rare MUcociliary Clearance dIsorders

Cyprus62 participantsStarted 2025-05-01

Plain-language summary

The goal of this clinical trial is to learn whether using a high efficiency particulate air (HEPA) air purifier can improve respiratory health in children and adults with Cystic Fibrosis (CF) or Primary Ciliary Dyskinesia (PCD). The main questions it aims to answer are: Can using a HEPA air purifier at home reduce respiratory symptoms in people with CF or PCD? Can it improve lung function and overall health? Researchers will compare participants' health outcomes before and after the use of the HEPA air purifier to see if cleaner indoor air makes a measurable difference. Participants will: Visit the clinic for baseline health assessments (such as lung function and symptom questionnaires). Have two HEPA air purifiers installed in their home. One device will be placed in the main living area and one in the bedroom. Undergo exposure assessments during home visits to measure indoor air quality.

Who can participate

Age range6 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥6 years * Physician-confirmed diagnosis of CF or PCD, based on internationally accepted criteria. PCD diagnosis will be based on either a) a positive genetic test (bi-allelic disease-causing mutations) or b) TEM class 1 defect, as defined by the European Respiratory Society and American Thoracic Society guidelines for the diagnosis of PCD. CF diagnosis will be based on the diagnostic criteria of the European Cystic Fibrosis Society Patient Registry including: (a) two sweat chloride test values of at least 60 mmol/L, or (b) one sweat chloride test value of at least 60 mmol/L and two disease-causing CFTR mutations, or (c) typical CF features at clinical presentation and two disease-causing CFTR mutations if sweat chloride test value was less than 60 mmol/L or not reported. * Residing in a main household in Cyprus for at least 5 days per week during the study period. * Willingness and ability to provide informed consent (or approval with guardian consent for minors). Exclusion Criteria: * Active smoking * Hospitalization for any condition during the study period or lack of internet access, which is required for continuous data transmission

What they're measuring

A mean difference of at least 10% change in the lung clearance index (LCI), measured at baseline, midpoint, and end of the study, between the two intervention groups.

Timeframe: From baseline to the end of the study at 6 months.

Trial details

NCT IDNCT07417267

SponsorUniversity of Cyprus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04