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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 9 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 9 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 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.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,237,525 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

Media Library

0.9% saline Clinical Trial Eligibility Overview. Trial Name: NCT03822637 — Phase 4
Asthma Research Study Groups: 0.9% saline, 20% n-acetylcystine (NAC)
Asthma Clinical Trial 2023: 0.9% saline Highlights & Side Effects. Trial Name: NCT03822637 — Phase 4
0.9% saline 2023 Treatment Timeline for Medical Study. Trial Name: NCT03822637 — Phase 4

Frequently Asked Questions

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

Has the combination of n-acetylcystine and albuterol been declared safe by government regulators?

"Our team at Power has rated n-acetylcystine + albuterol as a 3 on our safety scale, implying it is an approved treatment due to the completion of Phase 4 trials."

Answered by AI

Who is eligible to join this research study?

"This clinical trial is seeking 30 individuals with asthma, aged between 18 and 80. Qualified applicants can expect to be accepted in the study."

Answered by AI

What is the enrollment capacity of this medical study?

"Affirmative. According to clinicaltrials.gov, this research is still recruiting participants and was initially posted on February 20th 2019. Recent alterations were made on January 29th 2022, with the aim of enrolling 30 people at a single trial site."

Answered by AI

What ailments can be ameliorated with a combination of n-acetylcystine and albuterol?

"Patients who suffer from vasomotor rhinitis, bronchodilator agents and chronic obstructive pulmonary disease can benefit from n-acetylcystine + albuterol therapy."

Answered by AI

Is this trial actively searching for participants at the moment?

"Clinicaltrials.gov indicates that this experiment is actively recruiting participants; it was initially posted on February 20th 2019 and recently updated January 29th 2022."

Answered by AI

Are those over the age of 35 eligible to participate in this study?

"To take part in this trial, patients must be aged between 18 and 80. Furthermore, there are additional studies for those under 18 (130) and over 65 (233)."

Answered by AI

How have n-acetylcystine and albuterol been combined in past research efforts?

"Presently, 51 trials for the combination of n-acetylcystine and albuterol are ongiong. Of those studies, 7 have reached Phase 3 in development. Furthermore, there is a total of 90 locations across America running these tests; most notably located in Ann Arbor, Michigan."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Effect of NAC on Lung Function and CT Mucus Score
2019. "The Effect of NAC on Lung Function and CT Mucus Score". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03822637.
~5 spots leftby Apr 2025
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