Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis
|ClinicalTrials.gov Identifier: NCT02129803|
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : May 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Device: High-Flow, 20 LPM (via Optiflow cannula) Device: Low FLow, 5 LPM (via Optiflow cannula)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||May 29, 2019|
|Actual Study Completion Date :||May 29, 2019|
Experimental: Experimental Therapy
High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air
Device: High-Flow, 20 LPM (via Optiflow cannula)
Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2.
Placebo Comparator: Control Therapy (Low Flow)
Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air
Device: Low FLow, 5 LPM (via Optiflow cannula)
standard humidified wall medical air.
- Cystic Fibrosis Questionnaire-Revised (CFQ-R) [ Time Frame: Day 0 and Clinical Followup ]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.
- Sputum Collection [ Time Frame: 10 minutes ]Sputum is collected during pulmonary function test (PFT) to later measure the biophysical properties of cystic fibrosis sputum.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129803
|United States, Virginia|
|Children's Hospital of Richmond at VCU|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Bruce K Rubin, MD||Virginia Commonwealth University|