N/A
N=24
Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT02129803 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) — 0.056; 0.052; 0.192; 0.194 change in score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High-Flow, 20 LPM (via Optiflow cannula) (Device); Low FLow, 5 LPM (via Optiflow cannula) (Device)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) |
0.056; 0.052; 0.192; 0.194; -0.089; 0.033 | — |
| SECONDARY Sputum Collection |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02129803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.