N-Acetylcysteine for Patients With COPD and ChronicBronchitis

Sponsor

Center for Veterans Research and Education (Other)

Overall Status

Unknown status

CT.gov ID

NCT01599884

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease Chronic Bronchitis	Drug: N-acetylcysteine Drug: Oral acetylcysteine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

65 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2012

Anticipated Primary Completion Date :

May 1, 2013

Anticipated Study Completion Date :

Aug 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: N-acetylcysteine

N-acetylcysteine, 1800 mg twice daily

Drug: N-acetylcysteine

1800 mg twice daily for 8 weeks

Placebo Comparator: Sugar pill

Identical to active drug

Drug: Oral acetylcysteine

Identical placebo pills twice daily for 8 weeks

Outcome Measures

Primary Outcome Measures

Changes in the St. George's Respiratory Questionnaire [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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