Double Blind, Randomized, Placebo-controlled, Two-way Crossover, Pilot Study to Assess the Effect of High Dose N-acetylcysteine on Small Airways and on Inflammation and Oxidative Stress in COPD Patients.
N-acetylcysteine
+ placebo
Chronic Disease+5
+ Lung Diseases
+ Lung Diseases, Obstructive
Treatment Study
Summary
Study start date: March 1, 2009
Actual date on which the first participant was enrolled.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 patients with moderate COPD will be examined. These patients will receive a placebo for 12 weeks and NAC for 12 weeks in a dosage of 3 times 600 mg a day on top of their usual medication in a randomized crossover design. All subjects will be followed for 28 weeks. The effect of high dose NAC on small airways will be assessed by measuring the total and peripheral airway resistance calculated with Computational Fluid Dynamics (CFD). The effect on oxidative stress will be assessed by measuring exhaled NO and specific markers (CRP, erythrocyte sedimentation rate, IL-6, 8-isoprostane, H2O2, TNF-alfa, glutathione, GPX, SOD and IL-8) in blood and Exhaled Breath Condensate (EBC). Dynamic and static lung volumes will be assessed by spirometry, body plethysmography and diffusion. Quality of life and symptoms will be assessed by the St George Respiratory Questionnaire.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.12 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 40 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Patients with documented COPD based on the following criteria: * Smoking history of at least 10 pack-years * Decreased Tiffeneau index (FEV1/(FVC \< 0.70) 2. Patients aged ≥ 40 years 3. Patients who stopped smoking since more than 1 month 4. Patients who present moderate COPD with an FEV1 between 50 and 80% of predicted (GOLD 2) 5. Patients should be treated according to GOLD guidelines Exclusion Criteria: 1. Unstable patients who developed an exacerbation during the last 8 weeks 2. Patients who are current smokers or stopped less than 1 month 3. Patients who are allergic to acetylcysteine or to another element of the product 4. Patients with phenylketonuria or an untreated active peptic ulcer 5. Patients with any stage kidney and/or heart insufficiency or hypertension 6. Patients already treated with NAC for more than 6 months or during the last 3 months 7. Patients on continuous treatment with oral, inhalation, intravenous or intramuscular corticosteroids 8. Patients who are pregnant or are breast-feeding 9. Patients who are treated with orally administered cephalosporins 10. Patients using supplements containing antioxidants as vitamins C or E
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location