COPDNCT03935932
Study of Humidified Air to Improve Mucociliary Clearance (MCC) in COPD
A study testing nasal delivery of heated and humidified air in people with COPD, run by Frank C Sciurba at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- COPD
- What is being tested?
- nasal delivery of heated and humidified air
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2019to 15 Feb 2021
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female 40 to 85 years old
- Diagnosis of chronic bronchitis
- Able to regularly produce sputum
- Clinically stable
- Current smoker or ex-smoker with a tobacco history of ≥10 pack-years (1 pack year = 20 cigarettes smoked per day for 1 year)
- History of moderate to very severe COPD with a post-bronchodilator FEV1/FVC<0.70 and a post-bronchodilator FEV1>20% and ≤70% of predicted normal value at enrollment.
- CAT score ≥ 10, with questions 1 and 2 responses ≥ 5
Who cannot join
- Pregnant or nursing or unwilling to perform pregnancy testing
- Unwilling or unable to refrain for SABA/LABA use ahead of the study
- Unable to lie recumbent for 90 min,
- Clinically important pulmonary disease other than COPD (e.g. active lung infection, clinically significant bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency and primary ciliary dyskinesia) or another diagnosed pulmonary or systemic disease that is associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hyper-eosinophilic syndrome) and/ or radiological findings suggestive of a respiratory disease other than COPD that is contributing to the subject's respiratory symptoms.
- 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:
- Affect the safety of the subject throughout the study
Show all 11Show fewer
- Influence the findings of the study or their interpretation
- Impede the subject's ability to complete the entire duration of study
- Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 2 weeks prior to enrollment, based on last dose of steroids or last date of hospitalization whatever occurred later
- Acute upper or lower respiratory infection within 2 weeks prior to enrollment
- Supplemental oxygen use at greater than 3 liters/min
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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:
- A conversation with a physician and completion of informed consent
- Pulmonary function testing (including albuterol administration)
- The completion of a series of questionnaires
Study days 2 and 3 include:
- A urine pregnancy test (if applicable)
- Performance of a Co57 transmission scan
- The inhalation of a radiopharmaceutical (Technetium-99m sulfur colloid) from a nebulizer
- Lying flat in a nuclear medicine camera for 90 minutes while scans are collected.
- Remaining at the test center for a follow up scan approximately 2.5 hours later. This scan will take 10 minutes.
- Nasal delivery of heated humidified air (with supplemental oxygen if needed) at a rate of 30 liters per minute through a nasal cannula, on one study day. This will be started during the first 10 minutes of the 90 minute scanning period and continued for 4 hours. One the other study day there will be no treatment so that a baseline measurement of mucociliary clearance can be made. The order of the study days will be randomized.
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.
- Conditions
- COPD
- Being tested
- nasal delivery of heated and humidified air
- Keywords
- COPD, Chronic bronchitis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal delivery of heated and humidified airDevice
Also called Fisher and Paykel myAirvo2 heater/humidifier, Optiflow nasal cannula.
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.
| Study group | Role | What they receive |
|---|---|---|
| baseline followed by intervention | Experimental | 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 Receives: Device: nasal delivery of heated and humidified air |
| intervention followed by baseline | Experimental | 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 Receives: Device: nasal delivery of heated and humidified air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucociliary Clearance Rate - 4 Hours
Percentage of radioactivity cleared from the right lung
Measured: 0-4 hours
Secondary outcomes (2)
Mucociliary Clearance Rate - 90 Min
Percentage of radioactivity cleared from the right lung
Measured: 0-90 minutes
Area Above Retention Curve - 90 Min
Area above the curve of normalized retention of radioactivity vs time from the right lung
Measured: 0-90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start15 Jul 2019
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
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.
- Other trials for COPDStudies 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
- Crossover
- Model description
- Open label, single treatment administration, crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frank C Sciurba
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Sponsor-investigator, Frank C Sciurba, University of Pittsburgh
- Investigators
- Frank C Sciurba, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935932
- Sponsor's protocol ID
- STUDY19110243
- Status last verified
- Jun 2023
- First submitted
- 30 Apr 2019
- Last updated
- 8 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Humidified Air to Improve Mucociliary Clearance (MCC) in COPD
- ClinicalTrials.gov ID
- NCT03935932
- Acronym / sponsor ID
- STUDY19110243
- Conditions
- COPD
- Keywords
- COPD, Chronic bronchitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Frank C SciurbaUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Posted 8 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- A conversation with a physician and completion of informed consent
- Pulmonary function testing (including albuterol administration)
- The completion of a series of questionnaires
Study days 2 and 3 include:
- A urine pregnancy test (if applicable)
- Performance of a Co57 transmission scan
- The inhalation of a radiopharmaceutical (Technetium-99m sulfur colloid) from a nebulizer
- Lying flat in a nuclear medicine camera for 90 minutes while scans are collected.
- Remaining at the test center for a follow up scan approximately 2.5 hours later. This scan will take 10 minutes.
- Nasal delivery of heated humidified air (with supplemental oxygen if needed) at a rate of 30 liters per minute through a nasal cannula, on one study day. This will be started during the first 10 minutes of the 90 minute scanning period and continued for 4 hours. One the other study day there will be no treatment so that a baseline measurement of mucociliary clearance can be made. The order of the study days will be randomized.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, single treatment administration, crossover
| Arm | Type | Receives |
|---|---|---|
| baseline followed by intervention | Experimental | Device: nasal delivery of heated and humidified airSubjects 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 |
| intervention followed by baseline | Experimental | Device: nasal delivery of heated and humidified airSubjects 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 |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or Female 40 to 85 years old
- Diagnosis of chronic bronchitis
- Able to regularly produce sputum
- Clinically stable
- Current smoker or ex-smoker with a tobacco history of ≥10 pack-years (1 pack year = 20 cigarettes smoked per day for 1 year)
Key exclusion criteria (11 listed)
- Pregnant or nursing or unwilling to perform pregnancy testing
- Unwilling or unable to refrain for SABA/LABA use ahead of the study
- Unable to lie recumbent for 90 min,
- Clinically important pulmonary disease other than COPD (e.g. active lung infection, clinically significant bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency and primary ciliary dyskinesia) or another diagnosed pulmonary or systemic disease that is associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hyper-eosinophilic syndrome) and/ or radiological findings suggestive of a respiratory disease other than COPD that is contributing to the subject's respiratory symptoms.
- 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:
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 |
|---|---|---|
| nasal delivery of heated and humidified airAlso: Fisher and Paykel myAirvo2 heater/humidifier, Optiflow nasal cannula.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. | Device | baseline followed by intervention, intervention followed by baseline |
Primary outcome
Mucociliary Clearance Rate - 4 Hours
Time frame: 0-4 hours
Percentage of radioactivity cleared from the right lung
2 secondary outcomes
Mucociliary Clearance Rate - 90 Min
Time frame: 0-90 minutes
Area Above Retention Curve - 90 Min
Time frame: 0-90 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Frank C Sciurba, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasal delivery of heated and humidified air in people with COPD, run by Frank C Sciurba 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 7 inclusion and 11 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 8 Jun 2023. 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 8 Jun 2023). 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?
Mucociliary Clearance Rate - 4 Hours (time frame: 0-4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2023.