Researching the Effects of Airway Clearance Therapies in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— REACT-CF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03078127
• Other study ID #: 16-1813
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: January 10, 2018

Study information

• Verified date: January 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 10, 2018
• Est. primary completion date: January 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Mucociliary Clearance Defect

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Marsico Clinical Research Center	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Cystic Fibrosis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mucociliary Clearance-274	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).	274 minutes
Secondary	Mucociliary Clearance-90	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. This outcome for this study was the area under the particle clearance curve from time 0 to 90 minutes post-inhalation (normalized to time by dividing by 90) and expressed as a percent, representing average rate of mucociliary clearance (MCC) over 90 minutes.	90 minutes
Secondary	Change in Rate of MCC	Change in slope of particle clearance curve between pre intervention and ACT period.	pre-ACT (0-16 mins) and during ACT (16-50 mins)
Secondary	Change in Fraction of Exhaled Nitric Oxide (FENO)	FENO measurements were obtained pre- and post- intervention. The difference of post- vs pre- ACT FENO was reported.	pre and immediately post intervention (50 mins post inhalation)
Secondary	Purine Analysis (AMP) in Exhaled Breath Condensate	Exhaled breath condensate was collected using a commercial device for this purpose. Concentrations of the purine adenosine monophosphate (AMP) and urea in this liquid were determined using mass spectrometry. This outcome was the difference in concentrations of AMP normalized to urea in this exhaled breath condensate between post-ACT and pre-ACT intervention.	pre and immediately post intervention (50 mins post inhalation)
Secondary	Purine Analysis (Adenosine) in Exhaled Breath Condensate (EBC)	Difference of concentration of adenosine (a purine) in EBC between post-ACT and pre-ACT intervention.	pre and immediately post intervention (50 mins post inhalation)
Secondary	Purine Analysis (Hypoxanthine) in Exhaled Breath Condensate	Difference of concentration of hypoxanthine (a purine) in Exhaled Breath Condensate between post-ACT and pre-ACT intervention.	pre and immediately post intervention (50 mins post inhalation)