N-Acetylcysteine for Patients With COPD and Chronic Bronchitis

Inclusion Criteria:

- Capability to provide written informed consent

- Age ≥ 40 years and ≤ 85 years

- FEV1/FVC ratio (forced expiratory volume at 1 second/forced vital capacity) (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. 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 (glomerular filtration rate) 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 (white blood cell count) < 3.0 or > 15.0 K/cmm

- Hemoglobin < 9.0 or > 17.0 gm/dl

- Platelets < 75 or > 400 K/cmm

- ALT (Alanine transaminase enzyme) > 3 times the upper limit of normal

- INR (international normalized ratio) > 1.5 unless on warfarin therapy

- Any concomitant condition that might endanger the patient through participation in
the study or interfere with study procedures, as assessed by the investigator