NAC EFFECT ON OXIDATIVE STRESS AND MUSCLE FUNCTION IN COPD PATIENTS.

INTERVENTION: Trade Name: FLUMIL Product Name: N‐Acetylcysteine Pharmaceutical Form: Effervescent tablet INN or Proposed INN: N‐Acetilcisteína Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600‐ Pharmaceutical form of the placebo: Effervescent tablet Route of administration of the placebo: Oral use CONDITION: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). PRIMARY OUTCOME: Main Objective: Oxidative stress as judged by quantification of carbonyl groups on muscle (quadriceps and external intercostals) biopsy. Primary end point(s): Secondary Objective: To evaluate the effect of N‐acetylcysteine on: ; ‐ Exercise capacity (6 Minute Walking distance, Maximal Tolerated Load in the cycloergometrer); ‐ Peripheral (Quadriceps) and Respiratory muscle strength; ‐ Body composition (Fat free mass and BMI (Body Mass Index); ‐ Blood oxidative stress; To evaluate the safety of NAC at high doses in COPD patients; INCLUSION CRITERIA: This study will include 30 male ex‐smokers between 18‐65 years with stable severe COPD, (FEV1/FVC<70%, FEV1<50% predicted) as defined by the Global Initiative for chronic Obstructive Lung Disease guidelines. Informed written consent will be obtained. 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) no F.1.3.1 Number of subjects for this age range