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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Assaf-Harofeh Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00476736
First received: May 21, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Quality of Life
Exercise
Drug: Effect on small airways (N-Acetylcystein)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Reassessment Study of The Effect of N-Acetylcystein on Quality of Life and Air Trapping During Rest and After Exercise

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • inspiratory capacity [ Time Frame: 6 months ]

Estimated Enrollment: 30
Study Start Date: May 2007
Estimated Study Completion Date: May 2007
  Hide Detailed Description

Detailed Description:

Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity and mortality throughout the world. Many people suffer from this disease for years and die prematurely from it or its complications. COPD is the fourth leading cause of death in the world, and further increases in its prevalence and mortality can be predicted in the coming decades. COPD is characterized by a slowly progressing, irreversible airflow limitation caused by chronic inflammation in the bronchioles. It is diagnosed by performing spirometry. In the early stages, COPD can be asymptomatic, although episodes of coughing, often with sputum production, are not rare. In more advance stages, when there are also symptoms of shortness breath on exertion, a significant part of lung function may be reduced. The diagnosis of COPD is usually established in the later stages, and this diagnostic delay may either be due to the patient’s gradual adaptation to a decreasing lung function or denial of the disease. In addition, because doctors are unaware of, or not responding to the symptoms of the patient. The main cause of COPD is smoking and it often manifests itself after someone has been smoking more than 20 cigarettes a day over 20 years (20 pack years). A smoker who is "sensitive" to cigarette smoke may therefore have spirometric changes between the ages of 40 to 45 years if they started smoking as a teenager or early 20th. It has been estimated that 15–20% of smokers develop COPD, but more recent research suggests that as many as 50% develop COPD if the smoker reaches a high age.

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 in 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.

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 30 Moderate COPD (GOLD classification) , AGE 45-70, both sexes.
  • Treated with inhaled steroids and long acting beta agonists.

Exclusion Criteria:

  • Active ischemic heart disease, heart failure, orthopedic problems that preclude ergometric bicycle activity.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476736

Contacts
Contact: David Stav, MD (972(89779024 dstav@asaf.health.gov.il

Locations
Israel
Pulmonary Institute, Assaf Harofeh Medical Center Recruiting
Beer Yaakov, Israel, 70300
Contact: David Stav         
Principal Investigator: david Stav         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Study Chair: David Stav Tel Aviv University
  More Information

No publications provided by Assaf-Harofeh Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00476736     History of Changes
Other Study ID Numbers: 56/07
Study First Received: May 21, 2007
Last Updated: May 21, 2007
Health Authority: Israel: Ministry of Health

Keywords provided by Assaf-Harofeh Medical Center:
COPD
Pulmonary function
Air trapping
Acetyl cystein

ClinicalTrials.gov processed this record on September 18, 2014