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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 phenylketonurie 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 cefalosporines
10.Patients using supplements containing antioxidants as vitamins C or E

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objectives of this study are to assess the effect of high dose NAC (1800 mg):<br>•On small airways by measuring the total and peripheral airway resistance calculated with CFD<br>•On oxidative stress by measuring exhaled NO and oxidative stress markers (CRP, erythrocyte sedimentation rate, glutathione, GPX, SOD, IL-8, IL-6 and 8-isoprostane) in blood and EBC<br>measured at baseline, after 12 weeks of placebo and 12 weeks of NAC.<br>;Secondary Objective: The secondary objectives of this study are to assess:<br>•Dynamic and static lung volumes by spirometry, body plethysmography and diffusion<br>•Quality of life by the SGRQ<br>•Tolerability and safety of high dose NAC.<br>;Primary end point(s): Effect of delivery treatment

Secondary Outcome Measures

Name	Time	Method

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