AsthmaPhase 4TEAMNCT06152653
The Effects of Positive Airway Pressure on the Mucolytic Effects of NAC (TEAM)
A Phase 4 study testing n-acetylcystine (NAC)+ albuterol and AeroEclipse-VersaPAP System in people with Asthma and COPD, run by University of California, San Francisco at 1 site in United States.
Trial summary
The goal of this clinical trial is to determine if positive pressure during inspiration will improve penetration of aerosolized N-Acetylcysteine (NAC) into airway mucus plugs in the lungs of patients with asthma or Chronic Obstructive Pulmonary Disease (COPD). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- n-acetylcystine (NAC)+ albuterol and AeroEclipse-VersaPAP System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2024to Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Asthma Group:
- Male or female between the ages of 18 to 85 at Visit 1
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- Able to perform reproducible spirometry according to American Thoracic Society (ATS) criteria
- Clinical history of asthma per patient report or medical record
- Asthma requiring treatment with inhaled corticosteroids (ICS) or biologic therapy for 3 months or greater
Show all 18Show fewer
- Computed Tomography (CT) mucus score ≥ 3 (done as part of screening)
- There is no lower threshold on Forced Expiratory Volume in the first second (FEV1), which means the study will attempt to enroll all patients regardless of asthma severity. However, eligible participants will need to demonstrate ability to tolerate study treatment reflected by a post-treatment FEV1 ≥ 80% of pre- treatment, pre-bronchodilator FEV1. Participants who have a >20% drop in FEV1 after receiving any study treatment will be excluded from the study.
- For participants with known mucus plugging on CT: no limit on FEV1;
- For participants with unknown mucus plugging: FEV1<70% predicted
- COPD Group:
- Males or females between the ages 18 to 85 at the time of visit 1.
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- History of COPD per patient report or medical record and confirmed by an FEV1/FVC ratio of under 70%.
- Current or former smoker with a history of at least 10 pack-years of smoking.
- CT mucus score ≥ 3
- There is no lower threshold on FEV1, which means the study will attempt to enroll all patients regardless of COPD severity. However, eligible participants will need to demonstrate ability to tolerate study treatment reflected by a post-treatment FEV1 ≥ 80% of pre- treatment, pre-bronchodilator FEV1. Participants who have a >20% drop in FEV1 after receiving any study treatment will be excluded from the study.
- For participants with known mucus plugging on CT: no limit on FEV1; For participants with unknown mucus plugging: FEV1<50% predicted
Who cannot join
- A history of medical disease, which in the opinion of the investigator may put the subject at extra risk from study-related procedures or because the disease may influence the results of the study.
- Currently pregnant
- URI in past 10 days
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Airway Clinical Research Center
San Francisco, California, 94143
About this study
Official title: The Effects of Positive Airway Pressure on the Mucolytic Effects of NAC
The goal of this clinical trial is to determine if positive pressure during inspiration will improve penetration of aerosolized N-Acetylcysteine (NAC) into airway mucus plugs in the lungs of patients with asthma or Chronic Obstructive Pulmonary Disease (COPD).
The main questions it aims to answer are:
Read more
- Does delivery of aerosolized NAC with positive inspiratory pressure have a greater effect on mucus plug burden in the lungs than delivery of NAC without positive pressure.
- Does delivery of aerosolized NAC with positive inspiratory pressure have a greater effect on lung function than delivery of NAC without positive pressure.
Participants will be assigned (in a single blind design) to the NAC via jet nebulizer group or the NAC via AeroEclipse-VersaPAP nebulizer group. Participants will each complete 5 treatment visits over the course of 30 days. Each treatment visit will consist of two treatments of a 10% NAC (3 mL) and 2.5 mg albuterol (0.5mL) inhalation solution separated by 4 hours, via the nebulization method specific to their group.
Read the detailed description
The optimal method for delivering aerosolized N-acetyl cysteine (NAC, Mucomyst) to the airways for the purpose of lysing mucus plugs is not established. The challenge is to ensure that the NAC aerosol penetrates the mucus plug to lyse it. We hypothesize that increasing the inspiratory pressure during aerosol inhalation will improve mixing of NAC with plugs and increase the chance of lysis within the time that the NAC liquid medication "dwells" in the plugged airway segment. Usual nebulizer systems that generate aerosols for inhalation do not allow for application of pressure during inspiration, but the VersaPAP system (from Monaghan Medical Corporation) has this capability. Specifically, the VersaPAP system combines continuous positive pressure during inspiration while the patient inhales aerosol medication, and the pressure will generate viscous fingers in the mucus plugs to aid lysis.
Recent published work from the Fahy lab has revealed that airway mucus plugs can be identified on low dose CT scans of the lungs and quantified using a bronchopulmonary segment based system to generate a measure that quantifies the mucus plug burden in the lung. This CT based mucus plug scoring system provides a predictive and monitoring biomarker for mucus plug pathology in the lungs of patients with asthma and COPD.
This is a single-blind phase 4 clinical trial designed to help determine the optimal method of delivery of aerosolized NAC to patients with mucus-associated lung disease (asthma and COPD). Subjects will be screened for evidence of mucus in their lungs as determined by CT imaging. Eligible participants will then be assigned to the NAC via jet nebulizer group or the NAC via AeroEclipse-VersaPAP nebulizer group and complete 5 treatment visits over the course of 30 days. Each treatment visit will consist of two treatments of a 10% NAC (3 mL) and 2.5 mg albuterol (0.5mL) inhalation solution separated by 4 hours, via the nebulization method specific to their group.
- Being tested
- n-acetylcystine (NAC)+ albuterol, AeroEclipse-VersaPAP System
- Keywords
- Asthma, COPD, Mucolytic, Mucus Plug, Positive Pressure, NAC
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n-acetylcystine (NAC)+ albuterolDrug
Also called Mucomyst, NAC
NAC is a mucolytic drug and Albuterol is a bronchodilator.
AeroEclipse-VersaPAP SystemDevice
Also called VersaPAP System
The AeroEclipse-VersaPAP System combine continuous positive inspiratory pressure and nebulizer in one system.
| Study group | Role | What they receive |
|---|---|---|
| NAC via jet nebulizer | Active comparator | NAC (trade name: Mucomyst) is manufactured by American Regent. The active drug studied here is 10% NAC coadministered with albuterol and delivered via standard jet nebulizer. Participants will each complete 5 treatment visits over the course of 30 days. Each treatment visit will consist of two treatments separated by 4 hours. Receives: Drug: n-acetylcystine (NAC)+ albuterol |
| NAC via AeroEclipse-VersaPAP | Experimental | NAC (trade name: Mucomyst) is manufactured by American Regent. The active drug studied here is 10% NAC coadministered with albuterol and delivered via the AeroEclipse-VersaPAP system. Participants will each complete 5 treatment visits over the course of 30 days. Each treatment visit will consist of two treatments separated by 4 hours. Receives: Drug: n-acetylcystine (NAC)+ albuterol; Device: AeroEclipse-VersaPAP System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mucus plug score
The primary outcome is the % change in mucus plug score from 1 week before treatment to 1 week post treatment.
Measured: 1 week before treatment to 1 week post treatment, an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start9 Apr 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- John Fahy, MD, MS, Principal investigator, Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152653
- Sponsor's protocol ID
- 23-39679
- Other IDs
- 2R01HL080414-13A1
- Acronym
- TEAM
- Status last verified
- Aug 2026
- First submitted
- 22 Nov 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hays SR, Fahy JV. The role of mucus in fatal asthma. Am J Med. 2003 Jul;115(1):68-9. doi: 10.1016/s0002-9343(03)00260-2. No abstract available.
PubMed 12867239DUNNILL MS. The pathology of asthma, with special reference to changes in the bronchial mucosa. J Clin Pathol. 1960 Jan;13(1):27-33. doi: 10.1136/jcp.13.1.27.
PubMed 13818688Chui JY, de Anna P, Juanes R. Interface evolution during radial miscible viscous fingering. Phys Rev E Stat Nonlin Soft Matter Phys. 2015 Oct;92(4):041003. doi: 10.1103/PhysRevE.92.041003. Epub 2015 Oct 28.
PubMed 26565159Tang M, Elicker BM, Henry T, Gierada DS, Schiebler ML, Huang BK, Peters MC, Castro M, Hoffman EA, Fain SB, Ash SY, Choi J, Hall C, Phillips BR, Mauger DT, Denlinger LC, Jarjour NN, Israel E, Phipatanakul W, Levy BD, Wenzel SE, Bleecker ER, Woodruff PG, Fahy JV, Dunican EM. Mucus Plugs Persist in Asthma, and Changes in Mucus Plugs Associate with Changes in Airflow over Time. Am J Respir Crit Care Med. 2022 May 1;205(9):1036-1045. doi: 10.1164/rccm.202110-2265OC.
PubMed 35104436
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Positive Airway Pressure on the Mucolytic Effects of NAC
- ClinicalTrials.gov ID
- NCT06152653
- Acronym / sponsor ID
- TEAM / 23-39679
- Keywords
- Asthma, COPD, Mucolytic, Mucus Plug, Positive Pressure, NAC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine if positive pressure during inspiration will improve penetration of aerosolized N-Acetylcysteine (NAC) into airway mucus plugs in the lungs of patients with asthma or Chronic Obstructive Pulmonary Disease (COPD).
The main questions it aims to answer are:
- Does delivery of aerosolized NAC with positive inspiratory pressure have a greater effect on mucus plug burden in the lungs than delivery of NAC without positive pressure.
- Does delivery of aerosolized NAC with positive inspiratory pressure have a greater effect on lung function than delivery of NAC without positive pressure.
Participants will be assigned (in a single blind design) to the NAC via jet nebulizer group or the NAC via AeroEclipse-VersaPAP nebulizer group. Participants will each complete 5 treatment visits over the course of 30 days. Each treatment visit will consist of two treatments of a 10% NAC (3 mL) and 2.5 mg albuterol (0.5mL) inhalation solution separated by 4 hours, via the nebulization method specific to their group.
Detailed description
The optimal method for delivering aerosolized N-acetyl cysteine (NAC, Mucomyst) to the airways for the purpose of lysing mucus plugs is not established. The challenge is to ensure that the NAC aerosol penetrates the mucus plug to lyse it. We hypothesize that increasing the inspiratory pressure during aerosol inhalation will improve mixing of NAC with plugs and increase the chance of lysis within the time that the NAC liquid medication "dwells" in the plugged airway segment. Usual nebulizer systems that generate aerosols for inhalation do not allow for application of pressure during inspiration, but the VersaPAP system (from Monaghan Medical Corporation) has this capability. Specifically, the VersaPAP system combines continuous positive pressure during inspiration while the patient inhales aerosol medication, and the pressure will generate viscous fingers in the mucus plugs to aid lysis.
Recent published work from the Fahy lab has revealed that airway mucus plugs can be identified on low dose CT scans of the lungs and quantified using a bronchopulmonary segment based system to generate a measure that quantifies the mucus plug burden in the lung. This CT based mucus plug scoring system provides a predictive and monitoring biomarker for mucus plug pathology in the lungs of patients with asthma and COPD.
This is a single-blind phase 4 clinical trial designed to help determine the optimal method of delivery of aerosolized NAC to patients with mucus-associated lung disease (asthma and COPD). Subjects will be screened for evidence of mucus in their lungs as determined by CT imaging. Eligible participants will then be assigned to the NAC via jet nebulizer group or the NAC via AeroEclipse-VersaPAP nebulizer group and complete 5 treatment visits over the course of 30 days. Each treatment visit will consist of two treatments of a 10% NAC (3 mL) and 2.5 mg albuterol (0.5mL) inhalation solution separated by 4 hours, via the nebulization method specific to their group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAC via jet nebulizer | Active comparator | Drug: n-acetylcystine (NAC)+ albuterolNAC (trade name: Mucomyst) is manufactured by American Regent. The active drug studied here is 10% NAC coadministered with albuterol and delivered via standard jet nebulizer. Participants will each complete 5 treatment visits over the course of 30 days. Each treatment visit will consist of two treatments separated by 4 hours. |
| NAC via AeroEclipse-VersaPAP | Experimental | Drug: n-acetylcystine (NAC)+ albuterol, Device: AeroEclipse-VersaPAP SystemNAC (trade name: Mucomyst) is manufactured by American Regent. The active drug studied here is 10% NAC coadministered with albuterol and delivered via the AeroEclipse-VersaPAP system. Participants will each complete 5 treatment visits over the course of 30 days. Each treatment visit will consist of two treatments separated by 4 hours. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Male or female between the ages of 18 to 85 at Visit 1
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- Able to perform reproducible spirometry according to American Thoracic Society (ATS) criteria
- Clinical history of asthma per patient report or medical record
- Asthma requiring treatment with inhaled corticosteroids (ICS) or biologic therapy for 3 months or greater
Key exclusion criteria (3 listed)
- A history of medical disease, which in the opinion of the investigator may put the subject at extra risk from study-related procedures or because the disease may influence the results of the study.
- Currently pregnant
- URI in past 10 days
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 |
|---|---|---|
| n-acetylcystine (NAC)+ albuterolAlso: Mucomyst, NACNAC is a mucolytic drug and Albuterol is a bronchodilator. | Drug | NAC via AeroEclipse-VersaPAP, NAC via jet nebulizer |
| AeroEclipse-VersaPAP SystemAlso: VersaPAP SystemThe AeroEclipse-VersaPAP System combine continuous positive inspiratory pressure and nebulizer in one system. | Device | NAC via AeroEclipse-VersaPAP |
Primary outcome
Change in mucus plug score
Time frame: 1 week before treatment to 1 week post treatment, an average of 6 weeks
The primary outcome is the % change in mucus plug score from 1 week before treatment to 1 week post treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Background: PubMed 12867239Hays SR, Fahy JV. The role of mucus in fatal asthma. Am J Med. 2003 Jul;115(1):68-9. doi: 10.1016/s0002-9343(03)00260-2. No abstract available.
- Background: PubMed 13818688DUNNILL MS. The pathology of asthma, with special reference to changes in the bronchial mucosa. J Clin Pathol. 1960 Jan;13(1):27-33. doi: 10.1136/jcp.13.1.27.
- Background: PubMed 26565159Chui JY, de Anna P, Juanes R. Interface evolution during radial miscible viscous fingering. Phys Rev E Stat Nonlin Soft Matter Phys. 2015 Oct;92(4):041003. doi: 10.1103/PhysRevE.92.041003. Epub 2015 Oct 28.
- Background: PubMed 35104436Tang M, Elicker BM, Henry T, Gierada DS, Schiebler ML, Huang BK, Peters MC, Castro M, Hoffman EA, Fain SB, Ash SY, Choi J, Hall C, Phillips BR, Mauger DT, Denlinger LC, Jarjour NN, Israel E, Phipatanakul W, Levy BD, Wenzel SE, Bleecker ER, Woodruff PG, Fahy JV, Dunican EM. Mucus Plugs Persist in Asthma, and Changes in Mucus Plugs Associate with Changes in Airflow over Time. Am J Respir Crit Care Med. 2022 May 1;205(9):1036-1045. doi: 10.1164/rccm.202110-2265OC.
- 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.
John Fahy, MD, MS principal investigator
Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing n-acetylcystine (NAC)+ albuterol and AeroEclipse-VersaPAP System in people with Asthma and COPD, run by University of California, San Francisco 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 18 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in mucus plug score (time frame: 1 week before treatment to 1 week post treatment, an average of 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 NCT06152653, which also lists 4 linked publications.
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 13 Aug 2026.