Status:
COMPLETED
Pilot Study to Assess the Effect of High Dose N-acetylcysteine (NAC) in Chronic Obstructive Pulmonary Disease (COPD) Patients
Lead Sponsor:
University Hospital, Antwerp
Conditions:
COPD
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
Studies suggest that N-acetylcysteine (NAC) potentially reduces inflammation and hyperinflation in patients with COPD. In this pilot study the efficacy, safety and tolerability of high dose NAC in 12...
Eligibility Criteria
Inclusion
- Patients with documented COPD based on the following criteria:
- Smoking history of at least 10 pack-years
- Decreased Tiffeneau index (FEV1/(FVC \< 0.70)
- Patients aged ≥ 40 years
- Patients who stopped smoking since more than 1 month
- Patients who present moderate COPD with an FEV1 between 50 and 80% of predicted (GOLD 2)
- Patients should be treated according to GOLD guidelines
Exclusion
- Unstable patients who developed an exacerbation during the last 8 weeks
- Patients who are current smokers or stopped less than 1 month
- Patients who are allergic to acetylcysteine or to another element of the product
- Patients with phenylketonuria or an untreated active peptic ulcer
- Patients with any stage kidney and/or heart insufficiency or hypertension
- Patients already treated with NAC for more than 6 months or during the last 3 months
- Patients on continuous treatment with oral, inhalation, intravenous or intramuscular corticosteroids
- Patients who are pregnant or are breast-feeding
- Patients who are treated with orally administered cephalosporins
- Patients using supplements containing antioxidants as vitamins C or E
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00969904
Start Date
March 1 2009
End Date
January 1 2011
Last Update
July 3 2012
Active Locations (1)
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1
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650