N-Acetylcysteine for Patients With COPD and ChronicBronchitis

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic obstructive pulmonary disease, Chronic bronchitis, N-acetylcysteine Read More

Inclusion Criteria:

• Inclusion Criteria

  • Capability to provide written informed consent
  • Age ≥ 40 years and ≤ 85 years
  • FEV1/FVC ratio (post bronchodilator) < 70%
  • FEV1 (post bronchodilator) < 65%
  • Presence of chronic cough and sputum production defined as the following:

• Presence of chronic cough and sputum will be defined by responses to the first two questions on the SGRQ (see Appendix A). Subjects who respond positively to both question 1 (cough) and question 2 (sputum) on the SGRQ as either "several days per week" or "almost every day" will be eligible

  • Current or former smoker with lifetime cigarette consumption of at least 10 pack-years
  • Negative serum pregnancy test at the baseline visit if patient is a pre-menopausal female (menopause defined as absence of a menstrual cycle in the last 12 months)
  • Must be fluent in speaking the English language

• Exclusion Criteria

  • Not fully recovered for at least 30 days from a COPD exacerbation characterized by typical symptoms and treated with antibiotics or prednisone
  • Known allergy or sensitivity to NAC or albuterol
  • Any patient with unstable cardiac disease
  • Any patient with a documented history of uncompensated congestive heart failure in the last 2 years
  • Clinical diagnosis of asthma, bronchiectasis, cystic fibrosis, or severe alpha-1 antitrypsin deficiency
  • Active lung cancer or history of lung cancer if it has been less than 2 years since lung resection or other treatment. If history of lung cancer, must have no evidence of recurrence in the 2 years preceding the baseline visit.
  • Undergoing active treatment for malignancy except for hormonal therapy (i.e. prostate cancer, breast cancer) or non-metastatic skin cancer and are not symptomatic
  • Chronic kidney disease with an estimated GFR of < 30 ml/min. GFR will be estimated using the Modification of Diet in Renal Disease (MDRD) formula
  • History of cirrhosis with evidence of portal hypertension (ascites, chronic edema)
  • Participation in a pulmonary rehabilitation program or completion within past 6 weeks
  • Prisoners or institutionalized patients
  • Participation in another study involving an investigational product within 30 days of the baseline visit
  • Pregnant or breast-feeding patients.
  • Use of guaifenesin in the last 30 days
  • Currently on long acting nitrates for angina or heart failure
  • Abnormalities in screening blood work defined as:
• WBC < 3.0 or > 15.0 K/cmm
• Hemoglobin < 9.0 or > 17.0 gm/dl
• Platelets < 75 or > 400 K/cmm
• ALT > 3 times the upper limit of normal
• INR > 1.5 unless on warfarin therapy o Any concomitant condition that might endanger the patient through participation in the study or interfere with study procedures, as assessed by the investigator