Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Device: Low FLow, 5 LPM (via Optiflow cannula); Device: High-Flow, 20 LPM (via Optiflow cannula)

• Registration Number: NCT02129803
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

This study is a single center, randomized pilot study to evaluate the clinical effectiveness of nasal high flow 20LPM humidification therapy in subjects with Cystic Fibrosis.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-04-10
• Study First Submitted QC: 2014-05-01
• Study First Posted: 2014-05-02
• Study Start: 2015-05
• Primary Completion: 2019-05-29
• Study Completion: 2019-05-29
• Disposition First Submitted: 2020-04-28
• Disposition First Submitted QC: 2020-05-01
• Disposition First Posted: 2020-05-07
• Results First Submitted: 2020-11-30
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-04
• Last Update Submitted: 2021-01-04
• Results First Posted: 2021-01-06
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Confirmed diagnosis of CF
• Hospital admission for acute pulmonary exacerbation of CF (using Fuchs criteria 4/10)
• 10 years of age and older
• Subject is able to comply with the procedures scheduled in the protocol
• Signed informed consent form

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Exclusion Criteria

• Receipt of any aerosolized experimental or investigational drugs within 1 month of enrollment
• Subject had ear, nose, and throat (ENT) surgery, nasal bleeding, or nasal polyps within 6 months prior to study
• Subject is unlikely to comply with the procedures scheduled in the protocol
• Inability to give informed consent
• Subject requires supplemental oxygen
• History of obstructive sleep apnea
• History of pressure headaches requiring therapy within one month of enrollment
• Any other medical or psychological condition in which the study doctor(s) believe(s) would inhibit the individual from being an appropriate study subject.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Therapy (Low Flow)	Low FLow, 5 LPM (via Optiflow cannula)	Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air
Experimental Therapy	High-Flow, 20 LPM (via Optiflow cannula)	High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air

Primary Outcome Measures

Name	Time	Method
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R)	Day 0 to Day 6 or upon discharge from the hospital, whichever comes first	The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a validated health-related quality of life measure for CF that meets US Food and Drug Administration psychometric requirements for patient reported outcomes. It contains both generic and CF-specific scales and has demonstrated responsiveness in previous clinical studies. Scores range from 0 to 100 with higher scores indicating better health.

Secondary Outcome Measures

Name	Time	Method
Sputum Collection	10 minutes	Sputum is collected during pulmonary function test (PFT) to later measure the biophysical properties of cystic fibrosis sputum.

Trial Locations

Locations (1)

Children's Hospital of Richmond at VCU; 🇺🇸 Richmond, Virginia, United States