HHHFA in COPD Patients, With Chronic Bronchitis

NCT03959982 | Completed Results FDA Device

• 1 other identifier: 201905817
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Heated, humidified high-flow air (HHHFA) devices improve airway clearance. HHHFA use for an average of 1.6 hours a day in COPD patients with chronic bronchitis improves health-related quality of life, lung function, and delays the first respiratory exacerbation. However, HHHFA for an average of 1.6 hours a day had no effect on COPD exacerbation frequency or hospitalization, dyspnea, or exercise capacity, likely due to short duration of the treatment. Conversely, the effect of HHHFA for longer time periods on chronic bronchitis patients has not been studied. Moreover, the effect of HHHFA on sleep quality has not been studied. A prior study in COPD patients showed that use of HHHFA for more than 7 hours during sleep can be achieved. The overall objective of this research is to examine the effect of HHHFA during sleep on COPD patients with chronic bronchitis. In this pilot study, the study team will examine the effect of HHHFA during sleep on clinically relevant short-term outcomes including: respiratory symptoms, quality of life and sleep, lung function and exercise capacity. Subjects will be recruited and consented. Once a subject agrees to be in the study the baseline visit will occur. The first test will be the Pulmonary Function testing. If the subject qualifies based on the PFT's they will complete the remainder of the baseline visit. During this visit subjects will complete questionnaires, have a physical, 6 minute walk test and CT scan. Subjects will receive device training on the heated, humidified high-flow air device. Subjects will have a followup call between 3-7 days to check in on how the subject is doing with the device. After 6 weeks the subject will return for another round of testing as was done at baseline. This will be the final study visit.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Sleep Quality Using the PSQI Questionnaire

  Pittsburgh Sleep Quality Index (PSQI) Questionnaires will be done at baseline and completion of study. This questionnaire will be used to collect information regarding the subject's usual sleep habits during the past month. PSQI: Pittsburgh Sleep Quality Index ranges from 0 to 21 with highest scores indicating worse sleep quality. Values presented here indicate the change between baseline and 6 weeks. Positive values indicate worse sleep quality at 6 weeks.

  Baseline and 6 weeks

Secondary Outcomes (2)

• 6 Minute Walk

  Baseline and 6 weeks

• Health Related Quality of Life Change Using the CAT Questionnaire

  Baseline and 6 weeks

Study Arms (2)

HHHFA Randomized Group

EXPERIMENTAL

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.

Device: HHHFA Device; Diagnostic Test: Spirometry; Diagnostic Test: 6-minute walk; Diagnostic Test: CT scan; Other: Medical Research Council dyspnea scale (MRC); Other: St. George's Respiratory Questionnaire (SGRQ); Other: COPD Assessment Test (CAT); Other: Pittsburgh Sleep Quality Index (PSQI); Other: CASA-Q; Other: Spirehealth Tag Device

Control Group

ACTIVE COMPARATOR

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.

Diagnostic Test: Spirometry; Diagnostic Test: 6-minute walk; Diagnostic Test: CT scan; Other: Medical Research Council dyspnea scale (MRC); Other: St. George's Respiratory Questionnaire (SGRQ); Other: COPD Assessment Test (CAT); Other: Pittsburgh Sleep Quality Index (PSQI); Other: CASA-Q; Other: Spirehealth Tag Device

Interventions

HHHFA Device DEVICE

Participants will be instructed to use the HHHFA for at least 4 hours during their sleep but will be allowed to use it as long as they want during sleep.

HHHFA Randomized Group

Spirometry DIAGNOSTIC_TEST

Pre and post spirometry using albuterol.

Control Group; HHHFA Randomized Group

6-minute walk DIAGNOSTIC_TEST

6-minute walk

Control Group; HHHFA Randomized Group

CT scan DIAGNOSTIC_TEST

CT scan

Control Group; HHHFA Randomized Group

Medical Research Council dyspnea scale (MRC) OTHER

MRC questionnaire

Control Group; HHHFA Randomized Group

St. George's Respiratory Questionnaire (SGRQ) OTHER

SGRQ questionnaire

Control Group; HHHFA Randomized Group

COPD Assessment Test (CAT) OTHER

CAT questionnaire

Control Group; HHHFA Randomized Group

Pittsburgh Sleep Quality Index (PSQI) OTHER

PSQI questionnaire

Control Group; HHHFA Randomized Group

CASA-Q OTHER

CASA-Q questionnaire

Control Group; HHHFA Randomized Group

Spirehealth Tag Device OTHER

Subjects will wear the Spirehealth Tag Device to measure heart rate, respiratory rate, sleep time, physical activity (movement), and calories burned with activity.

Control Group; HHHFA Randomized Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD diagnosis by health care provider
• Post-bronchodilator FEV1/FVC \<0.7
• Post-bronchodilator FEV1%predicted \<70%
• Chronic bronchitis, defined as chronic cough with daily sputum production
• ≥2 COPD exacerbations within the last year
• Smart phone

You may not qualify if:

• Obstructive sleep apnea and using positive airway pressure treatment
• Patients that use oxygen supplementation continuously (patients that use oxygen supplementation only at exertion will NOT be excluded)
• Any planned procedure that the PI believes would cause the subject to be ineligible.
• Unable to perform a spirometry, 6-minute walk test or chest CT
• Recent diagnosis (\<4 weeks prior to study entry) of pneumonia, respiratory infection, COPD exacerbation, or acute bronchitis requiring antibiotics and new/increased dose of systemic corticosteroids
• Thoracic surgery or another procedure in the last six months that may result in instability of pulmonary status
• Recent medical or surgical history of upper airway disease that may interfere with intervention (e.g., sinus surgery, significant nasal polyps)
• Recent chest illness (trauma, pneumothorax etc).
• Basal skull surgery in the last 6 months
• Open skin ulcer or rash where the nasal cannula will be worn
• Tracheostomy or laryngectomy
• Pregnancy

Sponsors & Collaborators

• Spyridon Fortis: lead
• American Thoracic Society: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• Fortis S, Hoffman EA, Comellas AP. The Effect of Heated, Humidified High-Flow Air in COPD Patients With Chronic Bronchitis. Pulm Med. 2025 Dec 28;2025:8350741. doi: 10.1155/pm/8350741. eCollection 2025.

  PMID: 41496867 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Spirometry; Walking; Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Results Point of Contact

• Title: Dr. Spyridon Fortis
• Organization: University of Iowa

spyridon-fortis@uiowa.edu

319-356-4419

Study Officials

• Spyridon Fortis, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pricipal Investigator

Model Details: Subjects will be randomized into two groups: One will receive the device and one will not. Study procedures will be the same for both groups.

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 22, 2019
• Study Start: February 24, 2021
• Primary Completion: December 5, 2022
• Study Completion: December 5, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)