N-Acetylcysteine for Patients With COPD and Chronic Bronchitis

Not Applicable

Terminated

Conditions: COPD
Chronic Bronchitis

Interventions: Drug: N-Acetylcysteine
Drug: Placebo

Registration Number: NCT01739790

Lead Sponsor: University of Minnesota

Brief Summary: N-acetylcysteine (NAC) is described as having mucolytic and antioxidant properties. It is widely prescribed for patients with chronic obstructive lung disease (COPD), particularly for those who have accompanying symptoms of chronic cough and sputum production. Compared to placebo, high-dose NAC will improve Saint George Respiratory Questionnaire scores in patients with COPD and chronic bronchitis.

Detailed Description: A total of 130 subjects with COPD and chronic bronchitis will be randomized (in a double-blind fashion) to receive either high-dose NAC (1800 mg) or matching placebo twice daily for eight weeks. Respiratory health status, assessed by changes in St. George's Respiratory Questionnaire, will be used to determine the effects of NAC on lung function. It is anticipated that the subjects on high dose NAC will have improved scores.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 51

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N-Acetylcysteine	N-Acetylcysteine	1800 mg twice daily for 8 weeks
Sugar Pill	Placebo	Identical placebo pills twice daily for 8 weeks Placebo pills manufactured to mimic appearance of intervention drug n-acetylcysteine and prescribed with identical frequency and duration.

Primary Outcome Measures

Name	Time	Method
Changes in the Saint George's Respiratory Questionnaire	Baseline to 8 weeks	The St. George's Respiratory Questionnaire (SGRQ) is scored on a scale of 1 to 100 with 100 representing the worst respiratory health status. The instrument is self-administered at baseline and again after 8-weeks of treatment.

Secondary Outcome Measures