N/A
Completed N=10
Researching the Effects of Airway Clearance Therapies in Cystic Fibrosis
Cystic fibrosis · Mucociliary Clearance Defect
Source: ClinicalTrials.gov NCT03078127 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Mucociliary Clearance-274 — 20.3; 16.8; 18.5; 19.1 percent clearance — p=0.615
Summary
This is a pilot study investigating the effectiveness and clinical efficacy of airway clearance therapy (ACT) in cystic fibrosis (CF). Enrolled subjects will undergo measurements of mucociliary clearance (MCC) and exhaled biomarkers at baseline and after 3 different forms of ACT: high frequency chest wall oscillatory vest, oscillatory positive expiratory pressure device, and whole-body vibration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mucociliary Clearance-274 |
20.3; 16.8; 18.5; 19.1 | 0.615 |
| SECONDARY Mucociliary Clearance-90 |
13.8; 12.6; 12.4; 12.8 | 0.696 |
| SECONDARY Change in Rate of MCC |
0.011; .013; 0.011; 0.010 | — |
| SECONDARY Change in Fraction of Exhaled Nitric Oxide (FENO) |
-1.84; -1.81; -1.42; -.75 | 0.001 sig |
| SECONDARY Purine Analysis (AMP) in Exhaled Breath Condensate |
-0.206; -.101; -.036; 0.144 | 0.146 |
| SECONDARY Purine Analysis (Adenosine) in Exhaled Breath Condensate (EBC) |
-0.042; -0.027; -0.057; -.005 | 0.041 sig |
| SECONDARY Purine Analysis (Hypoxanthine) in Exhaled Breath Condensate |
-1.04; -1.93; 1.64; 0.760 | 0.070 |
Eligibility Criteria
Inclusion Criteria
- Adults with confirmed diagnosis of cystic fibrosis aged 18 years and older.
Exclusion Criteria
- Pregnant or lactating women,
- Individuals with severe lung disease (FEV1 <30%), or with exacerbations of lung disease requiring antibiotics or medication change within four weeks prior to enrolment.
- Individuals unable to use vest-based HFCWO, OPEP device, or who require oxygen supplementation at rest.
- Individuals with significant balance or gait impairment preventing them from tolerating being positioned on a vibrating platform.
Data sourced from ClinicalTrials.gov (NCT03078127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.