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The Effect of N-Acetylcystein on Quality of Life and Air Trapping During Rest and After Exercise

NCT00476736 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2007-05-22

No results posted yet for this study

Summary

Treatment of COPD patients depends on the stage of the disease. First of all it is strongly recommended quit smoking, then bronchodilators drugs are added. In more advanced stages inhaled corticosteroids and pulmonary rehabilitation are added. In hypoxemic patients a long term supplemental oxygen is advised.

The addition of sputum modifiers drugs is equivocal, since no objective improvement was documented.

N-Acetylcystein (NAC) is a drug known for its anti-oxidant and mucolytic activity. In animal models of disease it showed its beneficial activity , whereas in human such changes weren't demonstrated. In all the studies FEV1 was used to demonstrate the beneficial effect of the drug, although the disease changes are at the level of small airways which is almost not expressed by the measurement FEV1.

Purpose of the study

1. To estimate the damage severity at the small airways.
2. To estimate the change in quality of life.
3. To assess the pulmonary function changes at rest and following exercise, including parameters of air trapping (hyperinflation)

Methods \& Materials Patients - Inclusion - 30 Moderate COPD (GOLD classification) , AGE 45-70, both sexes. Treated with inhaled steroids and long acting beta agonists.

Exclusion - Active ischemic heart disease, heart failure, orthopedic problems that preclude ergometric bicycle activity.

Questionnaire - The St. George questionnaire for quality of life will be used . Pulmonary function testing- Lung volumes and spirometry un including inspiratory capacity will be measured before and after exercise.

Study protocol - 2 weeks run in, for observation disease stability and drug adherence.

Patient will randomly separated in 2 groups . Group A - will receive 600-1200 mg N-acetyl cystein twice daily. Group B - will receive as control placebo . Following 4 weeks of treatment patient will clinically re-examined and PFT's performed as described. After 2 weeks of washout group A. will serve as control and group B. will be treated with NAC as described.

Conditions

  • Quality of Life
  • Exercise

Interventions

DRUG

Effect on small airways (N-Acetylcystein)

Sponsors & Collaborators

  • Assaf-Harofeh Medical Center

    lead OTHER_GOV

Principal Investigators

  • David Stav · Tel Aviv University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Completion
2007-05-31

Countries

  • Israel

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00476736 on ClinicalTrials.gov