Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis

Study Overview
=================
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.

Official Title
-----------------
Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Device: High-Flow, 20 LPM (via Optiflow cannula)
* Device: Low FLow, 5 LPM (via Optiflow cannula)


Participation Criteria
=================
Eligibility Criteria
-----------------
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 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.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Therapy<br>High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air | Device: High-Flow, 20 LPM (via Optiflow cannula)<br>* Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2.<br>|
| Placebo Comparator: Control Therapy (Low Flow)<br>Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air | Device: Low FLow, 5 LPM (via Optiflow cannula)<br>* standard humidified wall medical air.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) | 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. | Day 0 to Day 6 or upon discharge from the hospital, whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sputum Collection | Sputum is collected during pulmonary function test (PFT) to later measure the biophysical properties of cystic fibrosis sputum. | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cystic Fibrosis, high flow 20 liters per minute (LPM) humidification therapy