NCT03078127

Researching the Effects of Airway Clearance Therapies in Cystic Fibrosis

Researching the Effects of Airway Clearance Therapies in Cystic Fibrosis (REACT-CF)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis
• Mucociliary Clearance Defect

Interventions

Type	Name	Description
OTHER	Baseline (Huff-Cough alone)	Subjects will provide two "huffs" (forced expiratory maneuver with open glottis) followed by a cough every six minutes for a total of six Huff-Coughs.
DEVICE	Oscillatory Positive Expiatory Pressure Device	Subjects will use an Areobika® branded OPEP device (10 breaths through highest tolerated resistance) prior to undergoing a Huff-Cough. Subjects will use the device six times every six minutes.
DEVICE	Whole-Body Vibration Platform	Subjects will be seated on a PowerPlate® whole-body vibration platform for 90 seconds prior to Huff-Cough. Six intervals on the platform will be completed six minutes apart.
DEVICE	High Frequency Chest Wall Oscillatory Vest	Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough.

Timeline

• Start date: 2017-02-01
• Primary completion: 2018-01-10
• Completion: 2018-01-10
• First posted: 2017-03-13
• Last updated: 2019-03-05
• Results posted: 2019-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study