N-Acetylcysteine for Patients With COPD and ChronicBronchitis
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ClinicalTrials.gov Identifier: NCT01599884 |
Recruitment Status
: Unknown
Verified May 2012 by Dennis Niewoehner, Minnesota Veterans Research Institute.
Recruitment status was: Not yet recruiting
First Posted
: May 16, 2012
Last Update Posted
: May 16, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease Chronic Bronchitis | Drug: N-acetylcysteine Drug: Oral acetylcysteine | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: N-acetylcysteine
N-acetylcysteine, 1800 mg twice daily
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Drug: N-acetylcysteine
1800 mg twice daily for 8 weeks
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Placebo Comparator: Sugar pill
Identical to active drug
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Drug: Oral acetylcysteine
Identical placebo pills twice daily for 8 weeks
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- Changes in the St. George's Respiratory Questionnaire [ Time Frame: 1 year ]

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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:
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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:
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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
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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

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): NCT01599884
Contact: Dennis Niewoehner | 612-467-4412 |
United States, Minnesota | |
Minneapolis VA Health Care System | Not yet recruiting |
Minneapolis, Minnesota, United States, 55417 | |
Contact: Dennis Niewoehner, MD 612-467-4412 |
Principal Investigator: | Dennis Niewoehner, MD | Minneapolis VA Health Care System |
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 Key Record Dates |
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 |