Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02129803
• Other study ID #: HM20002205
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: May 29, 2019

Study information

• Verified date: January 2021
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 29, 2019
• Est. primary completion date: May 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Device:
• High-Flow, 20 LPM (via Optiflow cannula)
Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2.
• Low FLow, 5 LPM (via Optiflow cannula)
standard humidified wall medical air.

Locations

Country	Name	City	State
United States	Children's Hospital of Richmond at VCU	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sputum Collection	Sputum is collected during pulmonary function test (PFT) to later measure the biophysical properties of cystic fibrosis sputum.	10 minutes