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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

Must not have

URI in past 10 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week before treatment to 1 week post treatment, an average of 6 weeks

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My asthma severity varies, but I can tolerate treatments without major lung function loss.

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I have COPD and either have mucus plugging with no FEV1 limit or unknown plugging with FEV1<50%.

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I have a history of asthma.

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I have COPD confirmed by a lung function test.

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I have been treating my asthma with inhaled steroids or biologic therapy for 3+ months.

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I have asthma with mucus plugging shown on CT or my asthma is severe with FEV1<70%.

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I am between 18 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had an upper respiratory infection in the last 10 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week before treatment to 1 week post treatment, an average of 6 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in mucus plug score

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 8Eligibility criteria met