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
  Show Detailed Description

  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 October 29, 2014