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New treatment option for Asthma
Official title The Effects of Positive Airway Pressure on the Mucolytic Effects of NAC (TEAM)
ClinicalTrials.gov ID: NCT06152653
What this study is testing
What is n-acetylcystine (NAC)+ albuterol?
n-acetylcystine (NAC)+ albuterol is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for asthma.
Also referred to as Mucomyst, NAC.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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
You likely can't join if
- 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...
- Currently pregnant
- URI in past 10 days
See the full eligibility criteria
- 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
- 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...
- 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...
- For participants with known mucus plugging on CT: no limit on FEV1; For participants with unknown mucus plugging: FEV1\<50% predicted
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.