Pulmonary Disease, Chronic ObstructiveNCT03959982
HHHFA in COPD Patients, With Chronic Bronchitis
A study testing HHHFA Device, Spirometry and 6-minute walk in people with Pulmonary Disease, Chronic Obstructive, run by Spyridon Fortis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- HHHFA Device, Spirometry and 6-minute walk
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2021to 5 Dec 2022
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Heated, Humidified High-flow Air in COPD Patients With Chronic Bronchitis
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.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is characterized by respiratory exacerbations which increase in frequency as the severity of the disease progresses. COPD exacerbations may lead to hospitalizations, which make up the largest proportion of the total direct health-care cost of the disease and are a significant burden for patients and family. Chronic bronchitis, defined as chronic cough with sputum production for at least 3 months a year for 2 consecutive years, is one of the clinical manifestations of COPD. Chronic bronchitis doubles the risk of COPD exacerbations and hospitalizations, and is associated with increased dyspnea, worse health-related quality of life, and poorer quality of sleep. Chronic bronchitis also results in increased air trapping and hyperinflation, which decreases exercise capacity. Unfortunately, other than traditional inhaled pharmacological agents, there are no treatment options for COPD patients with chronic bronchitis.
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.
Hypothesis 1: HHHFA during sleep in COPD patients with chronic bronchitis improves respiratory symptoms, sleep quality, lung function, and exercise capacity.
Aim 1: To examine the effect of HHHFA during sleep on respiratory symptoms, sleep quality, lung function, and exercise capacity in COPD patients with chronic bronchitis.
The effect of HHHFA on air trapping and hyperinflation has not been studied. Air trapping and hyperinflation as well as other radiographic measurements associated with chronic bronchitis (e.g. airway wall thickness) can be measured using chest CT.
Hypothesis 2: HHHFA during sleep in COPD patients with chronic bronchitis improves air trapping and hyperinflation.
Aim 2: To examine the effect of HHHFA in COPD patients with chronic bronchitis during sleep on air trapping and hyperinflation through chest CT imaging.
Design: The study team will include COPD subjects with a post-bronchodilator FEV1%predicted below 70% and chronic bronchitis. The study team will include subjects with at least 2 exacerbations in the last year to identify patients with significant burden due to chronic bronchitis. The study team will exclude subjects with recent respiratory events or procedures as the study team want to capture the benefit of HHHFA on chronic, stable COPD participants. Subjects who meet eligibility criteria will be randomized to HHHFA or usual care (Controls). At baseline the study team will perform measurements in all subjects that include dyspnea, cough, health-related quality of life, sleep quality, spirometry, a 6-minute walk test, and chest CT. All subjects, from both groups will also use the SPIREHEALTH Tag Device to measure their daily heart rate, respiratory rate, patient activity and calories. The group that is randomized to use the HHHFA device will be provided the HHHFA device at the baseline visit. Subjects will use the device during sleep for 6 weeks and both the HHHFA arm and the control arm will return for a 6 week follow up visit. At the 6 week follow up visit, participants will repeat all baseline evaluations. The study team will compare variables (e.g. FEV1) between baseline and 6-week visit in each treatment group. The study team will also compare changes in those variables over time between groups. To evaluate the effect of treatment between baseline and 6 weeks, the study team will use linear mixed effect models controlling for demographics and lung function.
Subjects who have been using the HHHFA device will be asked to stop using the device for the next 6 weeks. Both arms will then have a follow up phone call at the end of the 6 weeks (12 week follow up phone call visit). Subjects from both arms will continue to use the SPIREHEALTH and that data will be collected for both arms during that 6 week period.
Subjects who were previously randomized to the HHHFA arm will be asked, at the 6 week follow up visit, if they would be interested in participating in an optional sub-study that would allow them to start using the HHHFA device again, after their 12 week follow up phone call for an additional 36 weeks (for a total study involvement of 48 weeks) The subjects will have follow up phone call visits at 24 weeks, 36 weeks, and 48 weeks. Subjects who were randomized to the HHHFA device but do not want to keep using the device will be given the option of continuing to participate but only will the follow up phone call visits. Respiratory exacerbations information will be collected at these phone call visits.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- HHHFA Device, Spirometry, 6-minute walk, CT scan, Medical Research Council dyspnea scale (MRC)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HHHFA DeviceDevice
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.
SpirometryDiagnostic test
Pre and post spirometry using albuterol.
6-minute walkDiagnostic test
6-minute walk
CT scanDiagnostic test
CT scan
Medical Research Council dyspnea scale (MRC)Other
MRC questionnaire
St. George's Respiratory Questionnaire (SGRQ)Other
SGRQ questionnaire
COPD Assessment Test (CAT)Other
CAT questionnaire
Pittsburgh Sleep Quality Index (PSQI)Other
PSQI questionnaire
CASA-QOther
CASA-Q questionnaire
Spirehealth Tag DeviceOther
Subjects will wear the Spirehealth Tag Device to measure heart rate, respiratory rate, sleep time, physical activity (movement), and calories burned with activity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks
Secondary outcomes (2)
6 Minute Walk
Change in 6 minute walk distance. 6 min walk: distance covered during 6 min walk in meters. Greater values indicate better exercise capacity.
Measured: Baseline and 6 weeks
Health Related Quality of Life Change Using the CAT Questionnaire
COPD Assessment Test (CAT) Questionnaires will be done at baseline and completion of study. This questionnaire will collect information regarding the subject's belief on the impact COPD is having on the wellbeing and daily life. CAT: COPD Assessment Test ranges from 0 to 40. Values presented here indicate the change between baseline and 6 weeks. Higher scores indicate worse quality of life due to COPD at 6 weeks.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start24 Feb 2021
- Primary completion5 Dec 2022
- Study completion5 Dec 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spyridon Fortis
- Sponsor type
- University, hospital or other
- Collaborators
- American Thoracic Society
- Responsible party
- Sponsor-investigator, Spyridon Fortis, University of Iowa
- Investigators
- Spyridon Fortis, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959982
- Sponsor's protocol ID
- 201905817
- Status last verified
- Aug 2024
- First submitted
- 17 May 2019
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 41496867
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Heated, Humidified High-flow Air in COPD Patients With Chronic Bronchitis
- ClinicalTrials.gov ID
- NCT03959982
- Acronym / sponsor ID
- 201905817
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Spyridon FortisUniversity, hospital or other
- Collaborators
- American Thoracic Society
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic obstructive pulmonary disease (COPD) is characterized by respiratory exacerbations which increase in frequency as the severity of the disease progresses. COPD exacerbations may lead to hospitalizations, which make up the largest proportion of the total direct health-care cost of the disease and are a significant burden for patients and family. Chronic bronchitis, defined as chronic cough with sputum production for at least 3 months a year for 2 consecutive years, is one of the clinical manifestations of COPD. Chronic bronchitis doubles the risk of COPD exacerbations and hospitalizations, and is associated with increased dyspnea, worse health-related quality of life, and poorer quality of sleep. Chronic bronchitis also results in increased air trapping and hyperinflation, which decreases exercise capacity. Unfortunately, other than traditional inhaled pharmacological agents, there are no treatment options for COPD patients with chronic bronchitis.
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.
Hypothesis 1: HHHFA during sleep in COPD patients with chronic bronchitis improves respiratory symptoms, sleep quality, lung function, and exercise capacity.
Aim 1: To examine the effect of HHHFA during sleep on respiratory symptoms, sleep quality, lung function, and exercise capacity in COPD patients with chronic bronchitis.
The effect of HHHFA on air trapping and hyperinflation has not been studied. Air trapping and hyperinflation as well as other radiographic measurements associated with chronic bronchitis (e.g. airway wall thickness) can be measured using chest CT.
Hypothesis 2: HHHFA during sleep in COPD patients with chronic bronchitis improves air trapping and hyperinflation.
Aim 2: To examine the effect of HHHFA in COPD patients with chronic bronchitis during sleep on air trapping and hyperinflation through chest CT imaging.
Design: The study team will include COPD subjects with a post-bronchodilator FEV1%predicted below 70% and chronic bronchitis. The study team will include subjects with at least 2 exacerbations in the last year to identify patients with significant burden due to chronic bronchitis. The study team will exclude subjects with recent respiratory events or procedures as the study team want to capture the benefit of HHHFA on chronic, stable COPD participants. Subjects who meet eligibility criteria will be randomized to HHHFA or usual care (Controls). At baseline the study team will perform measurements in all subjects that include dyspnea, cough, health-related quality of life, sleep quality, spirometry, a 6-minute walk test, and chest CT. All subjects, from both groups will also use the SPIREHEALTH Tag Device to measure their daily heart rate, respiratory rate, patient activity and calories. The group that is randomized to use the HHHFA device will be provided the HHHFA device at the baseline visit. Subjects will use the device during sleep for 6 weeks and both the HHHFA arm and the control arm will return for a 6 week follow up visit. At the 6 week follow up visit, participants will repeat all baseline evaluations. The study team will compare variables (e.g. FEV1) between baseline and 6-week visit in each treatment group. The study team will also compare changes in those variables over time between groups. To evaluate the effect of treatment between baseline and 6 weeks, the study team will use linear mixed effect models controlling for demographics and lung function.
Subjects who have been using the HHHFA device will be asked to stop using the device for the next 6 weeks. Both arms will then have a follow up phone call at the end of the 6 weeks (12 week follow up phone call visit). Subjects from both arms will continue to use the SPIREHEALTH and that data will be collected for both arms during that 6 week period.
Subjects who were previously randomized to the HHHFA arm will be asked, at the 6 week follow up visit, if they would be interested in participating in an optional sub-study that would allow them to start using the HHHFA device again, after their 12 week follow up phone call for an additional 36 weeks (for a total study involvement of 48 weeks) The subjects will have follow up phone call visits at 24 weeks, 36 weeks, and 48 weeks. Subjects who were randomized to the HHHFA device but do not want to keep using the device will be given the option of continuing to participate but only will the follow up phone call visits. Respiratory exacerbations information will be collected at these phone call visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| HHHFA Randomized Group | Experimental | 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 DeviceSubjects 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. |
| Control Group | Active comparator | 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 DeviceSubjects 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| HHHFA DeviceParticipants 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. | Device | HHHFA Randomized Group |
| SpirometryPre and post spirometry using albuterol. | Diagnostic test | Control Group, HHHFA Randomized Group |
| 6-minute walk6-minute walk | Diagnostic test | Control Group, HHHFA Randomized Group |
| CT scanCT scan | Diagnostic test | Control Group, HHHFA Randomized Group |
| Medical Research Council dyspnea scale (MRC)MRC questionnaire | Other | Control Group, HHHFA Randomized Group |
| St. George's Respiratory Questionnaire (SGRQ)SGRQ questionnaire | Other | Control Group, HHHFA Randomized Group |
| COPD Assessment Test (CAT)CAT questionnaire | Other | Control Group, HHHFA Randomized Group |
| Pittsburgh Sleep Quality Index (PSQI)PSQI questionnaire | Other | Control Group, HHHFA Randomized Group |
| CASA-QCASA-Q questionnaire | Other | Control Group, HHHFA Randomized Group |
| Spirehealth Tag DeviceSubjects will wear the Spirehealth Tag Device to measure heart rate, respiratory rate, sleep time, physical activity (movement), and calories burned with activity. | Other | Control Group, HHHFA Randomized Group |
Primary outcome
Sleep Quality Using the PSQI Questionnaire
Time frame: Baseline and 6 weeks
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.
2 secondary outcomes
6 Minute Walk
Time frame: Baseline and 6 weeks
Health Related Quality of Life Change Using the CAT Questionnaire
Time frame: Baseline and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41496867Fortis 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.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Disease, Chronic Obstructive
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
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.
Spyridon Fortis, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HHHFA Device, Spirometry and 6-minute walk in people with Pulmonary Disease, Chronic Obstructive, run by Spyridon Fortis 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 6 inclusion and 12 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 19 Sep 2024. 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. 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 19 Sep 2024). 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?
Sleep Quality Using the PSQI Questionnaire (time frame: Baseline and 6 weeks). 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 NCT03959982, which also lists 1 linked publication.
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 19 Sep 2024.