Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis
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|ClinicalTrials.gov Identifier: NCT02129803|
Recruitment Status : Recruiting
First Posted : May 2, 2014
Last Update Posted : September 13, 2019
|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)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group 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|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129803
|United States, Virginia|
|Children's Hospital of Richmond at VCU||Recruiting|
|Richmond, Virginia, United States, 23298|
|Contact: Ryan Hayden, B.S. 804-628-3921 Ryan.Hayden@vcuhealth.org|
|Contact: Meg Lessard, B.S. 804-628-3093 Margaret.Lessard@vcuhealth.org|
|Principal Investigator: Bruce K Rubin, MD|
|Principal Investigator:||Bruce K Rubin, MD||Virginia Commonwealth University|