N-Acetylcysteine for Patients With COPD and ChronicBronchitis

This study is not yet open for participant recruitment.
Verified May 2012 by Minnesota Veterans Research Institute
Sponsor:
Information provided by (Responsible Party):
Dennis Niewoehner, Minnesota Veterans Research Institute
ClinicalTrials.gov Identifier:
NCT01599884
First received: May 15, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

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 Intervention
Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
Drug: N-acetylcysteine
Drug: Oral acetylcysteine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Minnesota Veterans Research Institute:

Primary Outcome Measures:
  • Changes in the St. George's Respiratory Questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 65
Study Start Date: June 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01599884

Contacts
Contact: Dennis Niewoehner 612-467-4412

Locations
United States, Minnesota
Minneapolis VA Health Care System Not yet recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Dennis Niewoehner, MD    612-467-4412      
Sponsors and Collaborators
Minnesota Veterans Research Institute
Investigators
Principal Investigator: Dennis Niewoehner, MD Minneapolis VA Health Care System
  More Information

No publications provided

Responsible Party: Dennis Niewoehner, Staff physician, Minnesota Veterans Research Institute
ClinicalTrials.gov Identifier: NCT01599884     History of Changes
Other Study ID Numbers: MVMREF-001
Study First Received: May 15, 2012
Last Updated: May 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Minnesota Veterans Research Institute:
Chronic obstructive pulmonary disease
Chronic bronchitis
N-acetylcysteine

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Pulmonary Disease, Chronic Obstructive
Acute Disease
Lung Diseases
Respiration Disorders
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on April 21, 2014