N-Acetylcysteine for Patients With COPD and ChronicBronchitis

Study Overview
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Brief Summary
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N-acetylcysteine (NAC) is described as having mucolytic and antioxidant properties. It is widely prescribed for patients with chronic obstructive pulmonary disease (COPD), particularly for those who have accompanying symptoms of chronic cough and sputum production. Randomized, placebo controlled indicate that it is safe and that it may have some clinical benefit when used at relatively low doses. It is postulated that substantially higher doses of NAC will be well-tolerated and will provide better symptom control while also decreasing blood makers of oxidant stress and inflammation.

Official Title
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Effects of High-Dose N-Acetylcysteine on Respiratory Health Status in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis: A Randomized, Placebo-Controlled Trial-1

Conditions
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Chronic Obstructive Pulmonary Disease, Chronic Bronchitis

Intervention / Treatment
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* Drug: N-acetylcysteine
* Drug: Oral acetylcysteine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: N-acetylcysteine<br>N-acetylcysteine, 1800 mg twice daily | Drug: N-acetylcysteine<br>* 1800 mg twice daily for 8 weeks<br>|
| Placebo Comparator: Sugar pill<br>Identical to active drug | Drug: Oral acetylcysteine<br>* Identical placebo pills twice daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the St. George's Respiratory Questionnaire |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic obstructive pulmonary disease, Chronic bronchitis, N-acetylcysteine