Cystic FibrosisNCT02129803

Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis

A study testing High-Flow, 20 LPM (via Optiflow cannula) and Low FLow, 5 LPM (via Optiflow cannula) in people with Cystic Fibrosis, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 10 to 50 years
Conditions the study is for: Cystic Fibrosis
What is being tested?: High-Flow, 20 LPM (via Optiflow cannula) and Low FLow, 5 LPM (via Optiflow cannula)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: May 2015to 29 May 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 50 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Hospital of Richmond at VCU
Richmond, Virginia, 23298

Other trials in United States

About this study

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.

Conditions: Cystic Fibrosis
Being tested: High-Flow, 20 LPM (via Optiflow cannula), Low FLow, 5 LPM (via Optiflow cannula)
Keywords: Cystic Fibrosis, high flow 20 liters per minute (LPM) humidification therapy
Medical subject headings: Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT02129803
Study group	Role	What they receive
Experimental Therapy	Experimental	High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air Receives: 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 Receives: Device: Low FLow, 5 LPM (via Optiflow cannula)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 0 to Day 6 or upon discharge from the hospital, whichever comes first

Secondary outcomes (1)

Sputum Collection
Sputum is collected during pulmonary function test (PFT) to later measure the biophysical properties of cystic fibrosis sputum.
Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 201529 May 2019

First posted2 May 2014 (estimated)
Study startMay 2015
Primary completion29 May 2019
Study completion29 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cystic FibrosisStudies of the same condition, open and under way.
More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02129803
Sponsor's protocol ID: HM20002205
Status last verified: Jan 2021
First submitted: 10 Apr 2014
Last updated: 6 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cystic Fibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis
ClinicalTrials.gov ID: NCT02129803
Acronym / sponsor ID: HM20002205
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis, high flow 20 liters per minute (LPM) humidification therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Virginia Commonwealth UniversityUniversity, hospital or other
Study start: May 2015
Primary completion: 29 May 2019 (actual)
Study completion: 29 May 2019 (actual)
First posted: 2 May 2014 (estimated)
Results: Posted 6 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Experimental Therapy	Experimental	Device: High-Flow, 20 LPM (via Optiflow cannula)High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air
Control Therapy (Low Flow)	Placebo comparator	Device: Low FLow, 5 LPM (via Optiflow cannula)Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air

Who may qualify

Ages: 10 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

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

Primary outcome

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.

1 secondary outcome

Sputum Collection
Time frame: 10 minutes

Results and safety

Results posted to the registry on 6 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental Therapy	12	6
Control Therapy (Low Flow)	12	9

Primary outcome: Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R)

Time frame: Day 0 to Day 6 or upon discharge from the hospital, whichever comes first. Mean (Standard Deviation). Unit: change in score on a scale

Measure	Experimental Therapy n = 3	Control Therapy (Low Flow) n = 8
Physical functioning subscale	0.056 (0.105)	0.052 (0.152)
Vitality subscale	0.192 (0.139)	0.194 (0.115)
Emotional state subscale	-0.089 (0.139)	0.033 (0.087)
Social limitations subscale	-0.056 (0.096)	-0.028 (0.154)
Role limitations subscale	-0.056 (0.192)	0.010 (0.175)
Body image subscale	0.037 (0.170)	0.125 (0.192)
Eating disturbances subscale	0.037 (0.280)	0.097 (0.162)
Treatment constraints subscale	-0.037 (0.170)	-0.097 (0.093)

Population analysed: Results could not be reported for 4 participants due to missing baseline data in one case, missing followup data in one case, and no CFQ-R data in two cases.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Length of hospital stay - up to 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental Therapy	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Control Therapy (Low Flow)	0 of 9 (0%)	1 of 9 (11.1%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cystic Fibrosis

RecruitingPhase 2
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Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bruce K Rubin, MD principal investigator

Virginia Commonwealth University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing High-Flow, 20 LPM (via Optiflow cannula) and Low FLow, 5 LPM (via Optiflow cannula) in people with Cystic Fibrosis, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) (time frame: Day 0 to Day 6 or upon discharge from the hospital, whichever comes first). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02129803.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.