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The effect of saline Plus on cystic fibrosis patients

Investigating the effectiveness of 7% plus hypertonic saline compared to 7%hypertonic saline in reducing the growth of Pseudomonas in the lungs of cystic fibrosis patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250217064754N1
Enrollment
64
Registered
2025-07-08
Start date
2025-06-05
Completion date
Unknown
Last updated
2025-07-21

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: Patients in the intervention group received 4 cc of 7% hypertonic saline plus nebulizer, manufactured by Samen Pharmaceutical Company, every 12 hours for three mont

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 14 Years

Inclusion criteria

Inclusion criteria: Have cystic fibrosis ability to expectorate sputum The patient is in stable condition Pseudomonas sputum culture The forced expiratory volume in the first second is greater than 50%.

Exclusion criteria

Exclusion criteria: Hyperreactive pulmonary disease Oxygen saturation less than 94% in room air or with supplemental oxygen Use of intravenous antibiotics during the previous four weeks Change in cystic fibrosis medications in the past four weeks

Design outcomes

Primary

MeasureTime frame
Colony growth rate of Pseudomonas aeruginosa in sputum of patients. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Pseudomonas colony count by throat culture.;The Forced Expiratory Volume in 1 second. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Spirometry.;The total forced vital capacity. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Spirometry.;Body mass index. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Meters and scales.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFaezeh Samadi

Mashhad University of Medical Sciences

fasamadi100@gmail.com+98 51 3866 5512

Outcome results

None listed

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