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

The effectiveness of oral N-acetylcysteine (NAC) comparing to placebo on quality of life and respiratory profile of patients aged 6 to 18 years old with cystic fibrosis having mild to moderate pulmonary involvement

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20090808002306N7

Enrollment

Registered

2021-07-17

Start date

2021-04-03

Completion date

Unknown

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic fibrosis. Other specified metabolic disorders

Interventions

Intervention 1: Intervention group: N acetylcysteine ??at a dose of 200 mg 3 times a day for 3 months by a pharmaceutical company. Intervention 2: Control group: receiving standard treatment for cysti

Eligibility

Sex/Gender

All

Age

6 Years to 18 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMir Ali Mohammed Sabzeghabaiei

Esfahan University of Medical Sciences

sabzghaba@pharm.mui.ac.ir+98 31 3792 7070

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026