Condition or disease | Intervention/treatment | Phase |
---|---|---|
COPD | Device: nasal delivery of heated and humidified air | Not Applicable |
Chronic bronchitis is a component of Chronic Obstructive Pulmonary Disease (COPD), along with emphysema. COPD is associated with smoking, exposure to environmental pollutants, or occupational exposures. In the airways mucus acts to trap inhaled toxins or pathogens. In a healthy lung mucus is cleared by mucociliary and cough clearance. Mucociliary clearance involves the synchronous motion of cilia underneath the mucus sheet that lines the airways. This drives the mucus sheet out of the airways (like a conveyer belt) continually clearing particulate and pathogens. In chronic bronchitis, mucus is overproduced due to toxic stimuli. Mucus clearance may also be defective due to airway obstruction and insufficient cough. This results in the accumulation of mucus that contributes to airway obstruction.
Therapies for improving mucus clearance may decrease the degree of airway obstruction experienced by COPD patients. Heated, high-flow, humidified air or oxygen may improve mucus clearance by hydrating the mucus in the airways and may also help to increase airway patency. A similar intervention was shown to improve mucus clearance in subjects with bronchiectasis.
The investigators have developed nuclear imaging-based methods for measuring mucus clearance from the lungs. These techniques have been applied to evaluate novel therapies for the treatment of cystic fibrosis lung disease. Here the investigators will apply these techniques to determine whether treatment with heated-humidified air will improve mucus clearance in subjects with COPD.
Study participation involves 3 visits.
Study day 1 includes:
Study days 2 and 3 include:
Participants will be asked to refrain from using short-acting beta agonist (SABA) medications for 6 hours prior to study days 2 and 3, and long-acting beta agonists (LABA) or long-acting muscarinic antagonists (LAMA) for 24 hours prior to study days 2 and 3.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Open label, single treatment administration, crossover |
Masking: | None (Open Label) |
Masking Description: | Open label |
Primary Purpose: | Treatment |
Official Title: | Study of Humidified Air to Improve Mucociliary Clearance (MCC) in COPD |
Actual Study Start Date : | July 15, 2019 |
Estimated Primary Completion Date : | November 30, 2021 |
Estimated Study Completion Date : | December 5, 2021 |
Arm | Intervention/treatment |
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Experimental: baseline followed by intervention
Subjects randomized to perform baseline measurement of clearance on study day 2 and measurement of clearance with nasal delivery of heated and humidified air on day 3
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Device: nasal delivery of heated and humidified air
Subjects will receive nasal delivery of heated and humidified air (plus oxygen if needed) at 30 liters/minute from the Fisher and Paykel myAirvo2 heater/humidifier using an Optiflow nasal cannula.
Other Names:
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Experimental: intervention followed by baseline
Subjects randomized to perform measurement of clearance with nasal delivery of heated and humidified air on day 2 and baseline measurement of clearance on study day 3
|
Device: nasal delivery of heated and humidified air
Subjects will receive nasal delivery of heated and humidified air (plus oxygen if needed) at 30 liters/minute from the Fisher and Paykel myAirvo2 heater/humidifier using an Optiflow nasal cannula.
Other Names:
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Ages Eligible for Study: | 40 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and/or could:
Contact: Tim Corcoran, Ph.D. | 412-692-2210 | corcorante@upmc.edu |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Anthony Wesolowski 412-692-2263 wesolowskiap2@upmc.edu |
Principal Investigator: | Frank C Sciurba, MD | University of Pittsburgh |
Tracking Information | |||||||
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First Submitted Date ICMJE | April 30, 2019 | ||||||
First Posted Date ICMJE | May 2, 2019 | ||||||
Last Update Posted Date | December 17, 2020 | ||||||
Actual Study Start Date ICMJE | July 15, 2019 | ||||||
Estimated Primary Completion Date | November 30, 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Mucociliary clearance rate - 4 hours [ Time Frame: 0-4 hours ] Percentage of radioactivity cleared from the right lung
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Study of Humidified Air to Improve Mucociliary Clearance (MCC) in COPD | ||||||
Official Title ICMJE | Study of Humidified Air to Improve Mucociliary Clearance (MCC) in COPD | ||||||
Brief Summary | This purpose of this study is to determine whether nasal delivery of heated and humidified air for a period of 4 hours will improve the clearance of mucus from the lungs of patients with chronic obstructive pulmonary disease (COPD). Mucus clearance will be measured using a nuclear medicine imaging procedure called a mucociliary clearance scan. Humidified air (with added oxygen if needed) will be delivered from the Fisher and Paykel myAirvo2 heater/humidifier through an Optiflow nasal cannula. | ||||||
Detailed Description |
Chronic bronchitis is a component of Chronic Obstructive Pulmonary Disease (COPD), along with emphysema. COPD is associated with smoking, exposure to environmental pollutants, or occupational exposures. In the airways mucus acts to trap inhaled toxins or pathogens. In a healthy lung mucus is cleared by mucociliary and cough clearance. Mucociliary clearance involves the synchronous motion of cilia underneath the mucus sheet that lines the airways. This drives the mucus sheet out of the airways (like a conveyer belt) continually clearing particulate and pathogens. In chronic bronchitis, mucus is overproduced due to toxic stimuli. Mucus clearance may also be defective due to airway obstruction and insufficient cough. This results in the accumulation of mucus that contributes to airway obstruction. Therapies for improving mucus clearance may decrease the degree of airway obstruction experienced by COPD patients. Heated, high-flow, humidified air or oxygen may improve mucus clearance by hydrating the mucus in the airways and may also help to increase airway patency. A similar intervention was shown to improve mucus clearance in subjects with bronchiectasis. The investigators have developed nuclear imaging-based methods for measuring mucus clearance from the lungs. These techniques have been applied to evaluate novel therapies for the treatment of cystic fibrosis lung disease. Here the investigators will apply these techniques to determine whether treatment with heated-humidified air will improve mucus clearance in subjects with COPD. Study participation involves 3 visits. Study day 1 includes:
Study days 2 and 3 include:
Participants will be asked to refrain from using short-acting beta agonist (SABA) medications for 6 hours prior to study days 2 and 3, and long-acting beta agonists (LABA) or long-acting muscarinic antagonists (LAMA) for 24 hours prior to study days 2 and 3. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Intervention Model Description: Open label, single treatment administration, crossover Masking: None (Open Label)Masking Description: Open label Primary Purpose: Treatment
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Condition ICMJE | COPD | ||||||
Intervention ICMJE | Device: nasal delivery of heated and humidified air
Subjects will receive nasal delivery of heated and humidified air (plus oxygen if needed) at 30 liters/minute from the Fisher and Paykel myAirvo2 heater/humidifier using an Optiflow nasal cannula.
Other Names:
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
12 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | December 5, 2021 | ||||||
Estimated Primary Completion Date | November 30, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years to 85 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03935932 | ||||||
Other Study ID Numbers ICMJE | PRO18110238 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Frank C Sciurba, University of Pittsburgh | ||||||
Study Sponsor ICMJE | Frank C Sciurba | ||||||
Collaborators ICMJE | Fisher and Paykel Healthcare | ||||||
Investigators ICMJE |
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PRS Account | University of Pittsburgh | ||||||
Verification Date | December 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |