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Oral N-acetylcysteine (NAC) effectiveness in cystic fibrosis (CF)

Phase 2
Recruiting
Conditions
Cystic fibrosis.
Other specified metabolic disorders
E88.8
Registration Number
IRCT20090808002306N7
Lead Sponsor
Esfahan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
45
Inclusion Criteria

1. The amount of chlorine in the sweat test is greater than or equal to 60 milliequivalents per liter or the presence of genotype containing two diagnostic mutations associated with CF and accompanied by one or more stable clinical symptoms specific to the specific phenotype of cystic fibrosis patients.
2. patients aged range of 6 to 18 years
3. The level of FEV1 or Forced Expiratory Volume is more than 50%
4. Stable clinical condition in the patient and no acute infection in the patient's upper and lower respiratory system
5. Do not aggravate the patient's pulmonary symptoms for 14 days before the patient's clinical examination

Exclusion Criteria

Disability to perform and repeat spirometry test according to American Thoracic Society criteria
use of other drugs out of the common treatment protocol that is effective on the disease.
Having possible history of underlying cardiovascular, renal, hepatic and biliary tract diseases

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Quality of life in children with cystic fibrosis;. Timepoint: At the beginning of the study and 3 months later,. Method of measurement: Cystic fibrosis Questionnaire -Revised (CFQR).;FEV1/FVC, proportion of a person's vital capacity that they are able to expire in the first second of forced expiration to the full, forced vital capacity. Timepoint: At the beginning of the study and 3 months later. Method of measurement: By spirometry.;FEV1, Forced Expiratory Volume in First Second. Timepoint: At the beginning of the study and 3 months later. Method of measurement: By spirometry.;FEF25-75, Exhale middle airflow. Timepoint: At the beginning of the study and 3 months later. Method of measurement: Spirometry.
Secondary Outcome Measures
NameTimeMethod
Quality of life in cystic fibrosis patients. Timepoint: At the first beginning of the study and 3 months later. Method of measurement: By a questionnaire Cystic Fibrosis Questionnaire -Revised (CFQR).
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