N-Acetylcysteine for Patients With COPD and Chronic Bronchitis
Primary Purpose
COPD, Chronic Bronchitis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
N-Acetylcysteine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring COPD, Chronic Bronchitis, N-acetylcysteine
Eligibility 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
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Sugar Pill
N-Acetylcysteine
Arm Description
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.
1800 mg twice daily for 8 weeks
Outcomes
Primary Outcome Measures
Changes in the Saint George's Respiratory Questionnaire
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01739790
First Posted
November 29, 2012
Last Updated
August 15, 2017
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT01739790
Brief Title
N-Acetylcysteine for Patients With COPD and Chronic Bronchitis
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 Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
PI discretion
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Chronic Bronchitis
Keywords
COPD, Chronic Bronchitis, N-acetylcysteine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
N-Acetylcysteine
Arm Type
Active Comparator
Arm Description
1800 mg twice daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
N-Acetylcysteine
Intervention Description
1800 mg twice daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Identical placebo manufactured to mimic appearance of intervention drug with identical frequency and duration.
Primary Outcome Measure Information:
Title
Changes in the Saint George's Respiratory Questionnaire
Description
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.
Time Frame
Baseline to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis E Niewoehner, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27143871
Citation
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.
Results Reference
result
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N-Acetylcysteine for Patients With COPD and Chronic Bronchitis
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