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Completed

NCT Number: NCT02129803

Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

10 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Richmond at VCU

Richmond, Virginia, 23298, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-Flow, 20 LPM (via Optiflow cannula)

Device

Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2.

Low FLow, 5 LPM (via Optiflow cannula)

Device

standard humidified wall medical air.

Primary outcomes

  1. Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R)

    Time frame: Day 0 to Day 6 or upon discharge from the hospital, whichever comes first

    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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
May 2, 2014
Registry last updated
Jan 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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