The Effect of N-Acetylcystein on Quality of Life and Air Trapping During Rest and After Exercise (NAC)
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|ClinicalTrials.gov Identifier: NCT00476736|
Recruitment Status : Unknown
Verified May 2007 by Assaf-Harofeh Medical Center.
Recruitment status was: Recruiting
First Posted : May 22, 2007
Last Update Posted : May 22, 2007
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
- To estimate the damage severity at the small airways.
- To estimate the change in quality of life.
- 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 or disease||Intervention/treatment||Phase|
|Quality of Life Exercise||Drug: Effect on small airways (N-Acetylcystein)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Reassessment Study of The Effect of N-Acetylcystein on Quality of Life and Air Trapping During Rest and After Exercise|
|Study Start Date :||May 2007|
|Estimated Study Completion Date :||May 2007|
- inspiratory capacity [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00476736
|Contact: David Stav, MD||(972(firstname.lastname@example.org|
|Pulmonary Institute, Assaf Harofeh Medical Center||Recruiting|
|Beer Yaakov, Israel, 70300|
|Contact: David Stav|
|Principal Investigator: david Stav|
|Study Chair:||David Stav||Tel Aviv University|