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HHHFA Device for Chronic Bronchitis
N/A
Recruiting
Led By Spyridon Fortis, MD
Research Sponsored by Spyridon Fortis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Study Summary
This trial is testing the effects of a heated, humidified high-flow air device on COPD patients with chronic bronchitis.
Eligible Conditions
- Chronic Obstructive Pulmonary Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6 minute walk
Dyspnea Change
X-Ray Computed Tomography
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: HHHFA Randomized GroupExperimental Treatment10 Interventions
Subjects will be randomized to use the HHHFA device during bedtime for at least 4 hours. Subjects will complete MRC, SGRQ, CAT, CASA-Q and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Group II: Control GroupActive Control9 Interventions
Subjects will complete MRC, SGRQ, CAT, and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spirometry
2017
Completed Phase 2
~11540
CT scan
2017
Completed Phase 2
~2360
Find a Location
Who is running the clinical trial?
Spyridon FortisLead Sponsor
American Thoracic SocietyOTHER
8 Previous Clinical Trials
622 Total Patients Enrolled
Spyridon Fortis, MDPrincipal Investigator - University of Iowa
University of Iowa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant.You have had two or more severe COPD flare-ups in the past year.You have recently had an injury or illness affecting your chest area.You need to have a smartphone.You have sleep apnea and are currently using a machine to help you breathe while you sleep.You have an open sore or rash where the nasal cannula will be placed.You have had surgery to remove your voice box (laryngectomy) or have a tube in your neck to help with breathing (tracheostomy).You need constant oxygen support.You had surgery on the base of your skull within the past 6 months.Within the last month, you had pneumonia, a respiratory infection, a COPD flare-up, or acute bronchitis that needed antibiotics and a higher dose of steroids.You have a long-term cough with daily mucus production, which is called chronic bronchitis.You are unable to do breathing tests or walk for 6 minutes without difficulty, or undergo a chest CT scan.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: HHHFA Randomized Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Iowa
What portion of applicants met pre-screening criteria?
Met criteria
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