Inpatient Clinical Trial of NAC
Condition: Asthma
Intervention: N-acetylcysteine
Intervention description: Research participants that meet the study inclusion criteria will be admitted to a medical-surgical ward in Moffitt-Long Hospital (UCSF Medical Center) for 6 days and 5 nights and treated with an inhaled mixture of NAC and albuterol four times per day spaced at 4 to 6 hours apart.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This is a single-arm study which means all study participants will receive the same treatment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the beneficial effect of n-acetylcysteine (NAC), an
      inhaled medication that breaks down mucus, on lung function. NAC is a medication approved by
      the US Food and Drug Administration (FDA) for the treatment of chronic diseases of the
      respiratory system, including asthma. With CT lung imaging, the investigators seek to
      identify a subgroup of patients with asthma with a 'mucus' profile. This is a single-arm
      study which means all participants will receive the same treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female between the ages of 18 and 80 years of age at Visit 1

          2. Written informed consent obtained from subject and ability for subject to comply with
             the requirements of the study.

          3. Able to perform reproducible spirometry according to ATS criteria

          4. Physiological evidence of airflow obstruction (FEV1 bronchodilator reversibility of ≥
             12% or hyperreactivity to methacholine reflected by a methacholine PC20 ≤ 16 mg/mL)

          5. Clinical history of asthma per patient report or medical record

          6. Pre-bronchodilator FEV1 > 35% predicted

          7. Post-bronchodilator FEV1 > 40% but < 90% predicted

          8. Asthma requiring treatment with inhaled corticosteroids (ICS) for 3 months or greater

          9. CT mucus score > 3

        Exclusion Criteria:

          1. Pregnant, breastfeeding, or unwilling to practice birth control during participation
             in the study.

          2. 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.

          3. Smoking of tobacco or other recreational inhalants in last year and/or >10 pack-year
             smoking history

          4. Current participation in an investigational drug trial

          5. 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

          6. Unwillingness to follow study procedures

          7. History of allergy or intolerance to study drug

          8. Any other criteria that places the subject at unnecessary risk according to the
             judgment of the Principal Investigator