The Effects of Positive Airway Pressure on the Mucolytic Effects of NAC (TEAM)

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06152653
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • n-acetylcystine (NAC)+ albuterol — DRUG
    NAC is a mucolytic drug and Albuterol is a bronchodilator.
  • AeroEclipse-VersaPAP System — DEVICE
    The AeroEclipse-VersaPAP System combine continuous positive inspiratory pressure and nebulizer in one system.

Study Details

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.

Key Dates

Start date
Apr 9, 2024
Status verified
Jul 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: NAC via jet nebulizer
    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.
  • Experimental: NAC via AeroEclipse-VersaPAP
    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.

Primary Outcome Measure

Change in mucus plug score [ Time Frame: 1 week before treatment to 1 week post treatment, an average of 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCSF Airway Clinical Research CenterSan FranciscoCalifornia94143
Jade Vi, BS
[email protected]
415-476-1783
John Fahy, MD, MS
[email protected]
415-476-9940
John Fahy, MD, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
AsthmaCOPD
By specialty
PulmonologyLung disease
By research site
UCSF Airway Clinical Research Center· San Francisco, CA

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