Chronic Obstructive Pulmonary DiseaseNCT01599884
N-Acetylcysteine for Patients With COPD and ChronicBronchitis
A study testing N-acetylcysteine and Oral acetylcysteine in people with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis, run by Center for Veterans Research and Education at 1 site in United States.
Trial summary
N-acetylcysteine (NAC) is described as having mucolytic and antioxidant properties. It is widely prescribed for patients with chronic obstructive pulmonary disease (COPD), particularly for those who have accompanying symptoms of chronic cough and sputum production. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Chronic Bronchitis
- What is being tested?
- N-acetylcysteine and Oral acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 (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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Dennis Niewoehner contact
United States1 site
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417
Dennis Niewoehner, MD, 612-467-4412
About this study
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
N-acetylcysteine (NAC) is described as having mucolytic and antioxidant properties. It is widely prescribed for patients with chronic obstructive pulmonary disease (COPD), particularly for those who have accompanying symptoms of chronic cough and sputum production. Randomized, placebo controlled indicate that it is safe and that it may have some clinical benefit when used at relatively low doses. It is postulated that substantially higher doses of NAC will be well-tolerated and will provide better symptom control while also decreasing blood makers of oxidant stress and inflammation.
- Being tested
- N-acetylcysteine, Oral acetylcysteine
- Keywords
- Chronic obstructive pulmonary disease, Chronic bronchitis, N-acetylcysteine
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
1800 mg twice daily for 8 weeks
Oral acetylcysteineDrug
Identical placebo pills twice daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine | Active comparator | N-acetylcysteine, 1800 mg twice daily Receives: Drug: N-acetylcysteine |
| Sugar pill | Placebo comparator | Identical to active drug Receives: Drug: Oral acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the St. George's Respiratory Questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Veterans Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Niewoehner, Center for Veterans Research and Education
- Investigators
- Dennis Niewoehner, MD, Principal investigator, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599884
- Sponsor's protocol ID
- MVMREF-001
- Status last verified
- May 2012
- First submitted
- 15 May 2012
- Last updated
- 16 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01599884
- Acronym / sponsor ID
- MVMREF-001
- Keywords
- Chronic obstructive pulmonary disease, Chronic bronchitis, N-acetylcysteine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Center for Veterans Research and EducationUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 16 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
N-acetylcysteine (NAC) is described as having mucolytic and antioxidant properties. It is widely prescribed for patients with chronic obstructive pulmonary disease (COPD), particularly for those who have accompanying symptoms of chronic cough and sputum production. Randomized, placebo controlled indicate that it is safe and that it may have some clinical benefit when used at relatively low doses. It is postulated that substantially higher doses of NAC will be well-tolerated and will provide better symptom control while also decreasing blood makers of oxidant stress and inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine | Active comparator | Drug: N-acetylcysteineN-acetylcysteine, 1800 mg twice daily |
| Sugar pill | Placebo comparator | Drug: Oral acetylcysteineIdentical to active drug |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetylcysteine1800 mg twice daily for 8 weeks | Drug | N-acetylcysteine |
| Oral acetylcysteineIdentical placebo pills twice daily for 8 weeks | Drug | Sugar pill |
Primary outcome
Changes in the St. George's Respiratory Questionnaire
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Niewoehner contact
Dennis Niewoehner, MD principal investigator
Minneapolis Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-acetylcysteine and Oral acetylcysteine in people with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis, run by Center for Veterans Research and Education at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dennis Niewoehner (612-467-4412), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the St. George's Respiratory Questionnaire (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2012.