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Completed

NCT Number: NCT03078127

Researching the Effects of Airway Clearance Therapies in Cystic Fibrosis

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Mucociliary Clearance Defect Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marsico Clinical Research Center

Chapel Hill, North Carolina, 27517, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Baseline (Huff-Cough alone)

Other

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.

Oscillatory Positive Expiatory Pressure Device

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.

Other names: Aerobika

Whole-Body Vibration Platform

Device

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.

Other names: PowerPlate

High Frequency Chest Wall Oscillatory Vest

Device

Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough.

Other names: TheVest

Primary outcomes

  1. 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

  1. Mucociliary Clearance-90

    Time frame: 90 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. 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.

  2. Change in Rate of MCC

    Time frame: pre-ACT (0-16 mins) and during ACT (16-50 mins)

    Change in slope of particle clearance curve between pre intervention and ACT period.

  3. Change in Fraction of Exhaled Nitric Oxide (FENO)

    Time frame: pre and immediately post intervention (50 mins post inhalation)

    FENO measurements were obtained pre- and post- intervention. The difference of post- vs pre- ACT FENO was reported.

  4. Purine Analysis (AMP) in Exhaled Breath Condensate

    Time frame: pre and immediately post intervention (50 mins post inhalation)

    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.

  5. Purine Analysis (Adenosine) in Exhaled Breath Condensate (EBC)

    Time frame: pre and immediately post intervention (50 mins post inhalation)

    Difference of concentration of adenosine (a purine) in EBC between post-ACT and pre-ACT intervention.

  6. Purine Analysis (Hypoxanthine) in Exhaled Breath Condensate

    Time frame: pre and immediately post intervention (50 mins post inhalation)

    Difference of concentration of hypoxanthine (a purine) in Exhaled Breath Condensate between post-ACT and pre-ACT intervention.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Official study title

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

Acronym: REACT-CF

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 13, 2017
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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