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Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-Flow, 20 LPM (via Optiflow cannula)
Low FLow, 5 LPM (via Optiflow cannula)
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, high flow 20 liters per minute (LPM) humidification therapy

Eligibility Criteria

10 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospital of Richmond at VCU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Therapy

Control Therapy (Low Flow)

Arm Description

High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air

Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 10, 2014
Last Updated
January 4, 2021
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT02129803
Brief Title
Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis
Official Title
Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 29, 2019 (Actual)
Study Completion Date
May 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic Fibrosis, high flow 20 liters per minute (LPM) humidification therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Therapy
Arm Type
Experimental
Arm Description
High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air
Arm Title
Control Therapy (Low Flow)
Arm Type
Placebo Comparator
Arm Description
Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air
Intervention Type
Device
Intervention Name(s)
High-Flow, 20 LPM (via Optiflow cannula)
Intervention Description
Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2.
Intervention Type
Device
Intervention Name(s)
Low FLow, 5 LPM (via Optiflow cannula)
Intervention Description
standard humidified wall medical air.
Primary Outcome Measure Information:
Title
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Description
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.
Time Frame
Day 0 to Day 6 or upon discharge from the hospital, whichever comes first
Secondary Outcome Measure Information:
Title
Sputum Collection
Description
Sputum is collected during pulmonary function test (PFT) to later measure the biophysical properties of cystic fibrosis sputum.
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce K Rubin, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Richmond at VCU
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

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Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis

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