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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003651-12-ES

Enrollment

Registered

2005-09-23

Start date

2005-11-11

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD).

Interventions

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 Concentra

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: This study will include 30 male ex-smokers between 18-65 years with stable severe COPD, (FEV1/FVC=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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: - 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 ;Primary end point(s):	—

Measure

Time frame

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: - 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 ;Primary end point(s):

—

Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026