N-Acetylcysteine for Patients With COPD and ChronicBronchitis

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated 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 :	June 2012
Estimated Primary Completion Date :	May 2013
Estimated Study Completion Date :	August 2013

Arms and Interventions

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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

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Primary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	40 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Medical Research and Education Foundation

Investigators

Principal Investigator:	Dennis Niewoehner, MD	Minneapolis VA Health Care System

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dennis Niewoehner, Staff physician, Minnesota Veterans Research Institute
ClinicalTrials.gov Identifier:	NCT01599884 History of Changes
Obsolete Identifiers:	NCT01639963
Other Study ID Numbers:	MVMREF-001
First Posted:	May 16, 2012
Last Update Posted:	May 16, 2012
Last Verified:	May 2012

Keywords provided by Dennis Niewoehner, Minnesota Veterans Research Institute:

Chronic obstructive pulmonary disease; Chronic bronchitis; N-acetylcysteine

Additional relevant MeSH terms:

Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Bronchitis; Bronchitis, Chronic; Respiratory Tract Diseases; Bronchial Diseases; Respiratory Tract Infections; Acetylcysteine; N-monoacetylcystine	Antiviral Agents; Anti-Infective Agents; Expectorants; Respiratory System Agents; Free Radical Scavengers; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs; Antidotes