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HHHFA in COPD Patients, With Chronic Bronchitis

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ClinicalTrials.gov Identifier: NCT03959982
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
American Thoracic Society
Information provided by (Responsible Party):
Spyridon Fortis, University of Iowa

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.


Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive 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 Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: The Effect of Heated, Humidified High-flow Air in COPD Patients With Chronic Bronchitis
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HHHFA Randomized Group
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
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.

Diagnostic Test: Spirometry
Pre and post spirometry using albuterol.

Diagnostic Test: 6-minute walk
6-minute walk

Diagnostic Test: CT scan
CT scan

Other: Medical Research Council dyspnea scale (MRC)
MRC questionnaire

Other: St. George's Respiratory Questionnaire (SGRQ)
SGRQ questionnaire

Other: COPD Assessment Test (CAT)
CAT questionnaire

Other: Pittsburgh Sleep Quality Index (PSQI)
PSQI questionnaire

Other: CASA-Q
CASA-Q questionnaire

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

Active Comparator: Control Group
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
Pre and post spirometry using albuterol.

Diagnostic Test: 6-minute walk
6-minute walk

Diagnostic Test: CT scan
CT scan

Other: Medical Research Council dyspnea scale (MRC)
MRC questionnaire

Other: St. George's Respiratory Questionnaire (SGRQ)
SGRQ questionnaire

Other: COPD Assessment Test (CAT)
CAT questionnaire

Other: Pittsburgh Sleep Quality Index (PSQI)
PSQI questionnaire

Other: CASA-Q
CASA-Q questionnaire

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




Primary Outcome Measures :
  1. Dyspnea Change [ Time Frame: 6 weeks ]
    Medical Research Council Dyspnoea Questionnaire (MRC)will be done at baseline and completion of study. The questionnaire asks subjects to rate between 0-4 how breathless they get during activity, with examples of each score. 0 being breathless only with strenuous exercise and 4 being too breathless to leave the house or when dressing.

  2. Health Related Quality of Life Change using the CAT Questionnaire [ Time Frame: 6 weeks ]
    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.

  3. Health Related Quality of Life Change using the SGRQ Questionnaire [ Time Frame: 6 weeks ]
    St. George's Respiratory Questionnaire (SGRQ) will be done at baseline and completion of study. The SGRQ collects information about which aspects of the subject's illness cause them the most problems and how often the subject reports experiencing the symptoms.

  4. Sleep Quality using the PSQI Questionnaire [ Time Frame: 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.

  5. Spirometry [ Time Frame: 6 weeks ]
    Change in spirometry measurements

  6. 6 minute walk [ Time Frame: 6 weeks ]
    Change in 6 minute walk distance



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959982


Contacts
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Contact: Spyridon Fortis, MD 319-353-8862 spyridon-fortis@uiowa.edu
Contact: Kimberly Sprenger 319-353-8862 kimberly-sprenger@uiowa.edu

Sponsors and Collaborators
Spyridon Fortis
American Thoracic Society
Investigators
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Principal Investigator: Spyridon Fortis, MD University of Iowa

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Responsible Party: Spyridon Fortis, Pricipal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT03959982     History of Changes
Other Study ID Numbers: New Protocol
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Bronchitis
Bronchitis, Chronic
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Infections