Clean Air for Rare MUcociliary Clearance dIsorders

NCT07417267 | Enrolling By Invitation DMC

• 2 other identifiers: 10103440.CARMUCIEEBK/EΠ/2025/35
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Ciliary Dyskinesia (PCD); Cystic Fibrosis (CF)

Keywords

Primary Ciliary Dyskinesia (PCD); Cystic Fibrosis (CF); Indoor Air Quality; Air Purification; Indoor Air Purification

Outcome Measures

Primary Outcomes (1)

• 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.

  Primary outcome will be a mean difference of at least 10% change in the LCI, measured using N2MBW (nitrogen (N2) multiple breath washout) testing at baseline, midpoint (end of first 3 months), and end of period 2 (end of the second 3-months period), between the two intervention groups.

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

Secondary Outcomes (12)

• Changes in forced oscillometry technique (FOT) indices measured at baseline, midpoint, and end of the study.

  From baseline to the end of the study at 6 months

• Changes in spirometry indices measured at baseline, midpoint, and end of the study.

  From baseline to the end of the study at 6 months

• Changes in health-related quality of life (HRQoL) measured at baseline, midpoint, and end of the study.

  From baseline to the end of the study at 6 months

• Changes in a seven consecutive day sleep-wake diary measured at baseline, midpoint, and end of the study.

  From baseline to the end of the study at 6 months

• Changes in the frequency of pulmonary exacerbations (self-reported and clinician-verified), use of medication and emergency healthcare visits, measured at baseline, midpoint, and end of the study.

  From baseline to the end of the study at 6 months

Study Arms (2)

Intervention configuration

EXPERIMENTAL

Air purifiers equipped with HEPA and three other filters for efficient particle filtration

Device: Intervention configuration - air purifiers equipped with HEPA and three other filters for efficient particle filtration

Control configuration

SHAM COMPARATOR

Air purifier configured to provide sham particle filtration

Device: Control configuration - air purifier configured to provide sham particle filtration

Interventions

Intervention configuration - air purifiers equipped with HEPA and three other filters for efficient particle filtration DEVICE

Following randomization, and depending on the surface of the residence, two portable air purifying devices (COWAY AP-1516D air purifier) will be placed in each participant's home. One device will be placed in the main living area and one in the bedroom. Depending on the allocated study leg, participants will have first devices with: 1\) Intervention configuration: HEPA filters combined with three additional filters for optimized removal of PM2.5, PM10, and airborne biological contaminants or Participants will be instructed to operate the devices continuously.

Intervention configuration

Control configuration - air purifier configured to provide sham particle filtration DEVICE

Following randomization, and depending on the surface of the residence, two portable air purifying devices (COWAY AP-1516D air purifier) will be placed in each participant's home. One device will be placed in the main living area and one in the bedroom. Depending on the allocated study leg, participants will have first devices with: 2\) Sham configuration: Identical units with filters removed to provide sham particle filtration. Participants will be instructed to operate the devices continuously

Control configuration

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Active smoking
• Hospitalization for any condition during the study period or lack of internet access, which is required for continuous data transmission

Sponsors & Collaborators

• University of Cyprus: lead
• Horizon 2020 - European Commission: collaborator

Study Sites (1)

Medical School, University of Cyprus

Nicosia, Aglantzia, 2029, Cyprus

Location

Related Publications (3)

• Bowerman C, Ratjen F, Stanojevic S. Estimating the minimum sample size for interventional and observational studies using the lung clearance index as an endpoint✰. J Cyst Fibros. 2023 Mar;22(2):356-362. doi: 10.1016/j.jcf.2022.11.003. Epub 2022 Nov 16.

  PMID: 36402729 BACKGROUND

• Pereira R, Barbosa T, Cardoso AL, Sa R, Sousa M. Cystic fibrosis and primary ciliary dyskinesia: Similarities and differences. Respir Med. 2023 Apr;209:107169. doi: 10.1016/j.rmed.2023.107169. Epub 2023 Feb 22.

  PMID: 36828173 BACKGROUND

• Aghapour, M. et al. Role of air pollutants in airway epithelial barrier dysfunction in asthma and COPD. European Respiratory Review 31 (2022).

  BACKGROUND

MeSH Terms

Conditions

Ciliary Motility Disorders; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics and Pediatric Pulmonology

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: February 18, 2026
• Study Start: May 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

CY (1)