← Back to Search

Bronchodilator

Positive Airway Pressure + NAC for COPD (TEAM Trial)

Phase 4
Recruiting
Led By John Fahy, MD, MS
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Asthma Group: There is no lower threshold on 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
COPD Group: For participants with known mucus plugging on CT: no limit on FEV1; For participants with unknown mucus plugging: FEV1<50% predicted
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week before treatment to 1 week post treatment, an average of 6 weeks
Awards & highlights

TEAM Trial Summary

This trial tests if a new way of delivering medicine to the lungs of people with asthma or COPD can improve airway blockages.

Who is the study for?
Adults aged 18-85 with asthma or COPD, who are current/former smokers (COPD group) and have a history of using inhaled corticosteroids or biologic therapy for asthma. Participants must be able to perform spirometry tests and have a CT mucus score ≥3. Pregnant individuals or those with recent upper respiratory infections are excluded.Check my eligibility
What is being tested?
The trial is testing if inhaling N-Acetylcysteine (NAC) combined with albuterol through positive pressure improves mucus clearance and lung function in patients compared to standard NAC inhalation without pressure. It's single-blind, meaning participants won't know which treatment they're getting.See study design
What are the potential side effects?
Potential side effects may include irritation of the airways, coughing, headache, mouth and throat dryness or soreness, nausea, rapid heart rate from albuterol; rare allergic reactions could occur.

TEAM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My asthma severity varies, but I can tolerate treatments without major lung function loss.
Select...
I have COPD and either have mucus plugging with no FEV1 limit or unknown plugging with FEV1<50%.
Select...
I have a history of asthma.
Select...
I have COPD confirmed by a lung function test.
Select...
I have been treating my asthma with inhaled steroids or biologic therapy for 3+ months.
Select...
I have asthma with mucus plugging shown on CT or my asthma is severe with FEV1<70%.
Select...
I am between 18 and 85 years old.

TEAM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week before treatment to 1 week post treatment, an average of 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week before treatment to 1 week post treatment, an average of 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in mucus plug score

TEAM Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NAC via AeroEclipse-VersaPAPExperimental Treatment2 Interventions
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.
Group II: NAC via jet nebulizerActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,852,104 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,507 Previous Clinical Trials
15,238,555 Total Patients Enrolled
John Fahy, MD, MSPrincipal InvestigatorProfessor of Medicine
2 Previous Clinical Trials
90 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who can partake in the research project?

"The requirements for participants to join this medical trial is that they must have COPD and be between 18-85 years old. As of now, approximately 20 people are being recruited."

Answered by AI

Is enrollment for this clinical experiment currently available to individuals?

"Affirmative. Per the information published on clinicaltrials.gov, this research project is actively searching for participants; it was initially announced on November 21st 2023 and the latest revision was made today, November 22nd 2023. Currently, they are accepting up to 20 individuals from a single site."

Answered by AI

How many individuals has this research enlisted thus far?

"Affirmative. The clinical trial is currently recruiting participants, as evidenced by its listing on clinicaltrials.gov which was initially uploaded on November 21st 2023 and subsequently amended the following day. This study necessitates obtaining information from twenty persons at one site."

Answered by AI

Does this investigation encompass individuals aged 55 and above?

"To take part in this medical trial, participants must be aged between 18 and 85. There are 138 studies for minors and 449 focused on those over 65 years of age."

Answered by AI

Is NAC through Hillrom-Volara a reliable and secure option for patients?

"The safety profile of NAC via Hillrom-Volara has been certified, earning it a score of 3. This is based on the fact that this treatment is already in Phase 4 trials."

Answered by AI

Who else is applying?

What site did they apply to?
UCSF Airway Clinical Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
The Effects of Positive Airway Pressure on the Mucolytic Effects of NAC (TEAM)
2024. "The Effects of Positive Airway Pressure on the Mucolytic Effects of NAC (TEAM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06152653.
All > Pediatric Asthma > Asthma
~13 spots leftby Nov 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top