Effect of hypertonic salin7% plus in treatment of Pseudomonas aeruginosa in the lung of the patient with cystic fibrosis disease.

Evaluation of the effectiveness of 7% plus hypertonic saline in comparison with 7% hypertonic saline in reducing the growth of Pseudomonas aeruginosa in lung of the patient with cystic fibrosis disease.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20201017049055N1

Enrollment

Registered

2021-04-23

Start date

2020-12-21

Completion date

Unknown

Last updated

2021-05-26

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

Conditions

cystic fibrosis. Cystic fibrosis

Interventions

Intervention 1: Intervention group: the usage of hypertonic saline 7% plus inhalation by a nebulizer ,twice a day for 2 months.drug Produced by Samen Pharmaceutical Company of Mashhad. Intervention 2

Eligibility

Sex/Gender

All

Age

6 Years to 13 Years

Inclusion criteria

Inclusion criteria: positive sputum culture with Pseudomonas aeruginosa The patient has the ability to excrete sputum The disease is in a stable condition (not in exacerbation) Forced expiratory volume(FEV1) is above 50%. have cystic fibrosis disease.

Exclusion criteria

Exclusion criteria: have hyper reactive airway disease. O2 saturation below 94%, in air room or when treated with oxygen. changes in cystic fibrosis drug over the past 4 weeks. have untreated reflux disease.

Design outcomes

Primary

Measure	Time frame
Nomber of colony count of pseudomonas aeroginosa. Timepoint: It is measured before prescribing the drug and then 2 months after prescribing the drug. Method of measurement: Counting colonies after sputum culture.;Weight. Timepoint: It is measured before prescribing the drug and then 2 months after prescribing the drug. Method of measurement: scale.;Forced expiratory volum in first second (FEV1). Timepoint: It is measured before prescribing the drug and then 2 months after prescribing the drug. Method of measurement: Spirometry.;LCI (Lung clearance index). Timepoint: It is measured before prescribing the drug and then 2 months after prescribing the drug. Method of measurement: Polmonary function test(LCI).;Quality of life. Timepoint: It is measured before prescribing the drug and then 2 months after prescribing the drug. Method of measurement: CFQ-R Questionnaire.;Forced vital capacity(FVC). Timepoint: It is measured before prescribing the drug and then 2 months after prescribing the drug. Method of measurement: Spirometry.	—

Measure

Time frame

Nomber of colony count of pseudomonas aeroginosa. Timepoint: It is measured before prescribing the drug and then 2 months after prescribing the drug. Method of measurement: Counting colonies after sputum culture.;Weight. Timepoint: It is measured before prescribing the drug and then 2 months after prescribing the drug. Method of measurement: scale.;Forced expiratory volum in first second (FEV1). Timepoint: It is measured before prescribing the drug and then 2 months after prescribing the drug. Method of measurement: Spirometry.;LCI (Lung clearance index). Timepoint: It is measured before prescribing the drug and then 2 months after prescribing the drug. Method of measurement: Polmonary function test(LCI).;Quality of life. Timepoint: It is measured before prescribing the drug and then 2 months after prescribing the drug. Method of measurement: CFQ-R Questionnaire.;Forced vital capacity(FVC). Timepoint: It is measured before prescribing the drug and then 2 months after prescribing the drug. Method of measurement: Spirometry.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFateme Tarighat monfared

Tehran University of Medical Sciences

fateme.tarighat@gmail.com+98 21 2227 6175

Outcome results

None listed

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