Last updated on August 2020

The Effect of NAC on Lung Function and CT Mucus Score

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Asthma | Asthma (Pediatric) | Allergies & Asthma
  • Age: Between 18 - 80 Years
  • Gender: Male or Female

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 American Thoracic Society (ATS) criteria
  4. 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)
  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 5
  10. Ability to tolerate study drug reflected by a post-treatment FEV1 80% of pretreatment, pre-bronchodilator FEV1

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. Adherence to study drug 70% after first treatment period
  5. Current participation in an investigational drug trial
  6. 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
  7. Unwillingness to follow study procedures
  8. History of allergy or intolerance to study drug
  9. Any other criteria that places the subject at unnecessary risk according to the judgment of the Principal Investigator

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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