N-Acetylcysteine for Patients With COPD and Chronic Bronchitis
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ClinicalTrials.gov Identifier: NCT01739790 |
Recruitment Status
:
Terminated
(PI discretion)
First Posted
: December 3, 2012
Results First Posted
: September 13, 2017
Last Update Posted
: September 13, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COPD Chronic Bronchitis | Drug: N-Acetylcysteine Drug: Placebo | Not Applicable |
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 |

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.
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Drug: Placebo
Identical placebo manufactured to mimic appearance of intervention drug with identical frequency and duration.
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Active Comparator: N-Acetylcysteine
1800 mg twice daily for 8 weeks
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Drug: N-Acetylcysteine
1800 mg twice daily for 8 weeks
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- 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.

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Ages Eligible for Study: | 40 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739790
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 |
Principal Investigator: | Dennis E Niewoehner, MD | University of Minnesota - Clinical and Translational Science Institute |
Publications of Results:
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 Key Record Dates |
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 |