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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 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

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 more

Trial 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

Heated, humidified high-flow air (HHHFA) device Clinical Trial Eligibility Overview. Trial Name: NCT03959982 — N/A
Chronic Obstructive Pulmonary Disease Research Study Groups: Control Group, HHHFA Randomized Group
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: Heated, humidified high-flow air (HHHFA) device Highlights & Side Effects. Trial Name: NCT03959982 — N/A
Heated, humidified high-flow air (HHHFA) device 2023 Treatment Timeline for Medical Study. Trial Name: NCT03959982 — N/A

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
~7 spots leftby Apr 2025