Researching the Effects of Airway Clearance Therapies in Cystic Fibrosis (REACT-CF)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cystic Fibrosis
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Mucociliary Clearance-274
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
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.
Outcomes
Primary Outcomes
Mucociliary Clearance-274
Time Frame: 274 minutes
As described in the protocol, gamma scintigraphy was used to measure clearance of particles from the whole right lung region of interest over 274 minutes. The primary outcome for this study was the area under the particle clearance curve from time 0 to 274 minutes post-inhalation (normalized to time by dividing by 274) and expressed as a percent, representing total average rate of mucociliary clearance (MCC).
Secondary Outcomes
- Change in Rate of MCC(pre-ACT (0-16 mins) and during ACT (16-50 mins))
- Purine Analysis (AMP) in Exhaled Breath Condensate(pre and immediately post intervention (50 mins post inhalation))
- Change in Fraction of Exhaled Nitric Oxide (FENO)(pre and immediately post intervention (50 mins post inhalation))
- Purine Analysis (Hypoxanthine) in Exhaled Breath Condensate(pre and immediately post intervention (50 mins post inhalation))
- Mucociliary Clearance-90(90 minutes)
- Purine Analysis (Adenosine) in Exhaled Breath Condensate (EBC)(pre and immediately post intervention (50 mins post inhalation))