N-Acetylcysteine for Patients With COPD and Chronic Bronchitis

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
COPD; Chronic Bronchitis	Drug: N-Acetylcysteine; Drug: Placebo	Not Applicable

Detailed Description:

A total of 130 subjects with COPD and chronic bronchitis will be randomized (in a double-blind fashion) to receive either high-dose NAC (1800 mg) or matching placebo twice daily for eight weeks. Respiratory health status, assessed by changes in St. George's Respiratory Questionnaire, will be used to determine the effects of NAC on lung function. It is anticipated that the subjects on high dose NAC will have improved scores.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	51 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-3
Study Start Date :	January 2013
Actual Primary Completion Date :	December 2015
Actual Study Completion Date :	December 2015

Arms and Interventions

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Arm	Intervention/treatment
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: Placebo; 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

Outcome Measures

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Primary Outcome Measures :

1. Changes in the Saint George's Respiratory Questionnaire [ Time Frame: Baseline to 8 weeks ]
   The St. George's Respiratory Questionnaire (SGRQ) is scored on a scale of 1 to 100 with 100 representing the worst respiratory health status. The instrument is self-administered at baseline and again after 8-weeks of treatment.

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:

• 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

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Locations

United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota - Clinical and Translational Science Institute

Investigators

Principal Investigator:	Dennis E Niewoehner, MD	University of Minnesota - Clinical and Translational Science Institute

More Information

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

Publications of Results:

Johnson K, McEvoy CE, Naqvi S, Wendt C, Reilkoff RA, Kunisaki KM, Wetherbee EE, Nelson D, Tirouvanziam R, Niewoehner DE. High-dose oral N-acetylcysteine fails to improve respiratory health status in patients with chronic obstructive pulmonary disease and chronic bronchitis: a randomized, placebo-controlled trial. Int J Chron Obstruct Pulmon Dis. 2016 Apr 21;11:799-807. doi: 10.2147/COPD.S102375. eCollection 2016.

Responsible Party:	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT01739790 History of Changes
Other Study ID Numbers:	1210M21542
First Posted:	December 3, 2012
Results First Posted:	September 13, 2017
Last Update Posted:	September 13, 2017
Last Verified:	August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:

COPD; Chronic Bronchitis; N-acetylcysteine

Additional relevant MeSH terms:

Bronchitis; Bronchitis, Chronic; Pulmonary Disease, Chronic Obstructive; Acute Disease; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Bronchial Diseases; Respiratory Tract Infections; Disease Attributes; Pathologic Processes; 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