The Effect of NAC on Lung Function and CT Mucus Score (ENACT)
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| ClinicalTrials.gov Identifier: NCT03822637 |
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Recruitment Status :
Not yet recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Asthma | Drug: n-acetylcystine + albuterol Drug: 0.9% saline + albuterol | Phase 4 |
N-acetylcystine (NAC) is a mucolytic medication, meaning that it breaks apart mucus. Investigators know that mucus is a factor in severe asthma attacks. However, mucus may be a factor in chronic severe asthma as well. This role has been hard to prove because of difficulty in showing that mucus occludes the lumen in chronic severe disease. Using a novel approach of scoring mucus occlusion, investigators have used CT imaging to uncover that a majority of people with severe asthma have at least one lung segment with a mucus plug and 27% have more than four lung segments with mucus plugs.
Historically, studies of mucolytics, like NAC, have not shown benefit in other obstructive lung diseases, like Chronic Obstructive Pulmonary Disease (COPD). However, utilizing CT mucus scores as a biomarker, investigators believe that mucolytic treatment may prove useful for those with significant mucus impaction.
This is a randomized, double-blind, placebo-controlled phase 4 study of 20% NAC in patients with asthma who also have evidence of mucus in their lungs as determined by CT imaging. Investigators hypothesize that by treating asthmatics, chosen based on the presence of mucus in the airways, with a mucolytic like NAC, will result in an improvement of lung function.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | The Effect of NAC on Lung Function and CT Mucus Score |
| Estimated Study Start Date : | March 2019 |
| Estimated Primary Completion Date : | March 2021 |
| Estimated Study Completion Date : | March 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 20% n-acetylcystine (NAC)
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.
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Drug: n-acetylcystine + albuterol
NAC is a mucolytic drug and Albuterol is a bronchodilator.
Other Names:
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Placebo Comparator: 0.9% saline
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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Drug: 0.9% saline + albuterol
Normal saline is a placebo agent and Albuterol is a bronchodilator.
Other Name: Normal saline |
- Change in FEV1 [ Time Frame: Through study completion, an average of 9 weeks ]The primary outcome is the % change in FEV1 from the start to the end of each two-week treatment period (either placebo or 20% NAC).
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female between the ages of 18 and 80 years of age 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
- Physiological evidence of airflow obstruction (FEV1 bronchodilator reversibility of ≥ 12% or hyperreactivity to methacholine reflected by a methacholine provocative concentration that results in a 20% fall in FEV1(PC20) ≤ 16 mg/mL)
- Clinical history of asthma per patient report or medical record
- Pre-bronchodilator FEV1 > 35% predicted
- Post-bronchodilator FEV1 > 40% but < 90% predicted
- Asthma requiring treatment with inhaled corticosteroids (ICS) for 3 months or greater
- CT mucus score ≥ 5
- Ability to tolerate study drug reflected by a post-treatment FEV1 ≥ 80% of pre- treatment, pre-bronchodilator FEV1
Exclusion Criteria:
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
- Smoking of tobacco or other recreational inhalants in last year and/or >10 pack-year smoking history
- Adherence to study drug ≤ 70% after first treatment period
- Current participation in an investigational drug trial
- Other chronic pulmonary disorders, including (but not limited to) cystic fibrosis, chronic obstructive pulmonary disease, chronic bronchitis, vocal cord dysfunction (that is the sole cause of respiratory symptoms and at the PI's discretion), severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways
- Unwillingness to follow study procedures
- History of allergy or intolerance to study drug
- Any other criteria that places the subject at unnecessary risk according to the judgment of the Principal Investigator
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03822637
| Contact: Ariana Baum, BA | 415-514-1539 | ariana.baum@ucsf.edu |
| United States, California | |
| UCSF Airway Clinical Research Center | |
| San Francisco, California, United States, 94143 | |
| Principal Investigator: | John Fahy, M.D, M.Sc. | University of California, San Francisco |
Publications:
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT03822637 History of Changes |
| Other Study ID Numbers: |
18-26680 |
| First Posted: | January 30, 2019 Key Record Dates |
| Last Update Posted: | January 30, 2019 |
| Last Verified: | January 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
| Product Manufactured in and Exported from the U.S.: | No | |
Additional relevant MeSH terms:
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Albuterol Acetylcysteine N-monoacetylcystine Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Tocolytic Agents Reproductive Control Agents Adrenergic beta-2 Receptor Agonists |
Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Expectorants Free Radical Scavengers Antioxidants Protective Agents Antidotes |