N-Acetylcysteine for Patients With COPD and Chronic Bronchitis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01739790
First received: November 29, 2012
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

N-acetylcysteine (NAC) is described as having mucolytic and antioxidant properties. It is widely prescribed for patients with chronic obstructive lung disease (COPD), particularly for those who have accompanying symptoms of chronic cough and sputum production. Compared to placebo, high-dose NAC will improve Saint George Respiratory Questionnaire scores in patients with COPD and chronic bronchitis.


Condition Intervention
COPD
Chronic Bronchitis
Drug: N-Acetylcysteine
Drug: Identical Placebo manufactured to mimic appearance of intervention drug with identical frequency and duration

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-3

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Changes in the Saint George's Respiratory Questionnaire [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar Pill
Identical placebo pills twice daily for 8 weeks Placebo pills manufactured to mimic appearance of intervention drug n-acetylcysteine and prescribed with identical frequency and duration.
Drug: Identical Placebo manufactured to mimic appearance of intervention drug with identical frequency and duration
Active Comparator: N-Acetylcysteine
1800 mg twice daily for 8 weeks
Drug: N-Acetylcysteine
1800 mg 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:

  • 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. 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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739790

Contacts
Contact: Ronald A Reilkoff, MD 612-624-0999 rreilkof@umn.edu
Contact: Cheryl Stibbe, RN 612-624-0999 edinx004@umn.edu

Locations
United States, Minnesota
University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Ronald A Reilkoff, MD    612-624-0999    rreilkof@umn.edu   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01739790     History of Changes
Other Study ID Numbers: 1210M21542
Study First Received: November 29, 2012
Last Updated: December 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
COPD
Chronic Bronchitis
N-acetylcysteine

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Acute Disease
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung 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 August 25, 2014