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NAC + Albuterol for Asthma (ENACT Trial)
Phase 4
Recruiting
Led By John Fahy, M.D, M.Sc.
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
Male or female between the ages of 18 and 80 years of age at Visit 1
Ability to tolerate study drug reflected by a post-treatment FEV1 ≥ 80% of pre- treatment, pre-bronchodilator FEV1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 9 weeks
Awards & highlights
ENACT Trial Summary
This trialevaluates 20% NAC to treat severe asthma affecting the airways, using CT imaging and a crossover design.
Who is the study for?
Adults aged 18-80 with moderate-to-severe asthma, a history of mucus in the airways confirmed by CT scan, and airflow obstruction are eligible. They must have been on inhaled corticosteroids for at least 3 months and be non-smokers for the past year. Pregnant or breastfeeding individuals, those not using birth control, or with other chronic lung conditions are excluded.Check my eligibility
What is being tested?
The trial is testing if inhaling a solution of n-acetylcysteine (NAC) improves lung function and reduces mucus in asthmatics. Participants will alternate between NAC and placebo every two weeks to compare effects. Everyone gets albuterol with both treatments.See study design
What are the potential side effects?
Possible side effects include irritation of the mouth or throat, coughing, headache, runny nose, nausea, vomiting and drowsiness. More serious but rare side effects might involve worsening breathing problems.
ENACT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
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My lung function remains strong after treatment.
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I have been using inhaled steroids for my asthma for 3 months or more.
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I have a history of asthma.
ENACT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 9 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 9 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in FEV1
ENACT Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 20% n-acetylcystine (NAC)Experimental Treatment1 Intervention
NAC (trade name: Mucomyst) is manufactured by American Regent. The active drug studied here is 20% NAC coadministered with albuterol and delivered via nebulizer three times per day for fourteen days.
Group II: 0.9% salinePlacebo Group1 Intervention
Normal saline will be coadministered with albuterol as the placebo agent via a nebulizer three times per day for fourteen days.
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,518 Previous Clinical Trials
15,241,699 Total Patients Enrolled
34 Trials studying Asthma
20,324 Patients Enrolled for Asthma
John Fahy, M.D, M.Sc.Principal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
1 Total Patients Enrolled
1 Trials studying Asthma
1 Patients Enrolled for Asthma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have smoked tobacco or other substances in the past year or have a history of smoking more than 10 pack-years.I am between 18 and 80 years old.My lung function remains strong after treatment.I have a chronic lung condition that affects my breathing.I have been using inhaled steroids for my asthma for 3 months or more.I have a history of asthma.
Research Study Groups:
This trial has the following groups:- Group 1: 0.9% saline
- Group 2: 20% n-acetylcystine (NAC)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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