N-Acetylcysteine for Patients With COPD and ChronicBronchitis

NCT ID: NCT01599884

Last Updated: 2012-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-08-31

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.

Conditions

Chronic Obstructive Pulmonary Disease; Chronic Bronchitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

N-acetylcysteine

N-acetylcysteine, 1800 mg twice daily

Group Type: ACTIVE_COMPARATOR

N-acetylcysteine

Intervention Type: DRUG

1800 mg twice daily for 8 weeks

Sugar pill

Identical to active drug

Group Type: PLACEBO_COMPARATOR

Oral acetylcysteine

Intervention Type: DRUG

Identical placebo pills twice daily for 8 weeks

Interventions

N-acetylcysteine

1800 mg twice daily for 8 weeks

Intervention Type: DRUG

Oral acetylcysteine

Identical placebo pills twice daily for 8 weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center for Veterans Research and Education

OTHER

Sponsor Role: lead

Responsible Party

Dennis Niewoehner

Staff physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dennis Niewoehner, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Veterans Affairs Medical Center

Locations

Minneapolis VA Health Care System

Minneapolis, Minnesota, United States

Countries

United States

Central Contacts

Dennis Niewoehner

Role: CONTACT

612-467-4412

Facility Contacts

Dennis Niewoehner, MD

Role: primary

612-467-4412

Other Identifiers

MVMREF-001

Identifier Type: -

Identifier Source: org_study_id

NCT01639963

Identifier Type: -

Identifier Source: nct_alias