N-Acetylcysteine for Patients With COPD and ChronicBronchitis

NCT01599884 | Unknown

• 1 other identifier: MVMREF-001
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Keywords

Chronic obstructive pulmonary disease; Chronic bronchitis; N-acetylcysteine

Outcome Measures

Primary Outcomes (1)

• Changes in the St. George's Respiratory Questionnaire

  1 year

Study Arms (2)

N-acetylcysteine

ACTIVE COMPARATOR

N-acetylcysteine, 1800 mg twice daily

Drug: N-acetylcysteine

Sugar pill

PLACEBO COMPARATOR

Identical to active drug

Drug: Oral acetylcysteine

Interventions

N-acetylcysteine DRUG

1800 mg twice daily for 8 weeks

N-acetylcysteine

Oral acetylcysteine DRUG

Identical placebo pills twice daily for 8 weeks

Sugar pill

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Center for Veterans Research and Education: lead

Study Sites (1)

Minneapolis VA Health Care System

Minneapolis, Minnesota, 55417, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Dennis Niewoehner, MD

  Minneapolis Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dennis Niewoehner

CONTACT

612-467-4412

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff physician

Study Record Dates

• First Submitted: May 15, 2012
• First Posted: May 16, 2012
• Study Start: June 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: August 1, 2013
• Last Updated: May 16, 2012

Record last verified: 2012-05

Locations

US (1)