N-Acetylcysteine for Patients With COPD and Chronic Bronchitis

August 15, 2017 updated by: University of Minnesota

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Dennis E Niewoehner, MD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

November 29, 2012

First Submitted That Met QC Criteria

November 29, 2012

First Posted (ESTIMATE)

December 3, 2012

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2017

Last Update Submitted That Met QC Criteria

August 15, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1210M21542

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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