AC EFFECT ON OXIDATIVE STRESS AND MUSCLE FUNCTION IN COPD PATIENTS.Efecto de NAC en estrés oxidativo y función muscular en pacientes con EPOC

Phase 1

• Conditions: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD).

• Registration Number: EUCTR2005-003651-12-ES
• Lead Sponsor: ZAMBON, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-23
• Study Completion: 2007-08-14
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 0

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

Exclusion Criteria

Exclusion criteria will be unstable COPD (i.e., exacerbation in the last 2 months), long-term supplemental oxygen and NAC treatment, neuromuscular disease, cardiac failure, diabetes mellitus, arthritis, phenylcetonuria, vascular disease and alcoholism or with a clinical condition or relevant analytical alterations. None of the patients can take systemic oral steroid medication in the 6 months before the study, and all medication regimens remained unchanged during the study period. Will be excluded supplementation with antioxidants or vitamins.
Also patients with NAC allergy will be excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Oxidative stress as judged by quantification of carbonyl groups on muscle (quadriceps and external intercostals) biopsy.;Secondary Objective: To evaluate the effect of N-acetylcysteine on: <br>- Exercise capacity (6 Minute Walking distance, Maximal Tolerated Load in the cycloergometrer)<br>- Peripheral (Quadriceps) and Respiratory muscle strength<br>- Body composition (Fat free mass and BMI (Body Mass Index)<br>- Blood oxidative stress<br>To evaluate the safety of NAC at high doses in COPD patients<br>;Primary end point(s):