NCT02129803

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 2, 2014

Completed
12 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2019

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

January 6, 2021

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

4.1 years

First QC Date

April 10, 2014

Results QC Date

November 30, 2020

Last Update Submit

January 4, 2021

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis, high flow 20 liters per minute (LPM) humidification therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Sputum Collection

    10 minutes

Study Arms (2)

Experimental Therapy

EXPERIMENTAL

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

Device: High-Flow, 20 LPM (via Optiflow cannula)

Control Therapy (Low Flow)

PLACEBO COMPARATOR

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

Device: Low FLow, 5 LPM (via Optiflow cannula)

Interventions

High-Flow, 20 LPM (via Optiflow cannula)DEVICE

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

Experimental Therapy
Low FLow, 5 LPM (via Optiflow cannula)DEVICE

standard humidified wall medical air.

Control Therapy (Low Flow)

Eligibility Criteria

Age10 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Confirmed diagnosis of CF
  • Hospital admission for acute pulmonary exacerbation of CF (using Fuchs criteria 4/10)
  • years of age and older
  • Subject is able to comply with the procedures scheduled in the protocol
  • Signed informed consent form

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Richmond at VCU

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Results Point of Contact

Title
Bruce K. Rubin MEngr, MD, MBA, FRCPC
Organization
Virginia Commonwealth University
bruce.rubin@vcuhealth.org
804 828 9604

Study Officials

  • Bruce K Rubin, MD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2014

First Posted

May 2, 2014

Study Start

May 1, 2015

Primary Completion

May 29, 2019

Study Completion

May 29, 2019

Last Updated

January 6, 2021

Results First Posted

January 6, 2021

Record last verified: 2021-01

Locations

US(1)