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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 : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

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
Allocation: Randomized
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 : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Sputum Collection [ Time Frame: 10 minutes ]
    Sputum is collected during pulmonary function test (PFT) to later measure the biophysical properties of cystic fibrosis sputum.



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Ages Eligible for Study:   10 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Bruce K Rubin, MD Virginia Commonwealth University

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02129803     History of Changes
Other Study ID Numbers: HM20001217
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018

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

Keywords provided by Virginia Commonwealth University:
Cystic Fibrosis, high flow 20 liters per minute (LPM) humidification therapy

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases