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Effect of 7% Hypertonic Saline Nebulization on Lung Function and Quality of Life in Chemical Warfare Veterans

Evaluation of the Impact of 7% Sodium Chloride Nebulization on Lung Function and Quality of Life in Chemical War Veterans

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250524065876N1
Enrollment
62
Registered
2025-08-23
Start date
2025-09-02
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Chemical pneumonitis induced by sulfur mustard gas. Bronchitis and pneumonitis due to chemicals, gases, fumes and vapors

Interventions

Intervention 1: Intervention group: Patients in the intervention group receive 7% sodium chloride solution (hypertonic saline) through an Omron NE-U22 mesh nebulizer device. The treatment protocol inc

Sponsors

Bagheiat-allah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Chemical warfare veteran with documented exposure to sulfur mustard gas Medically confirmed pulmonary complications due to sulfur mustard exposure Moderate to severe degree of pulmonary involvement Age between 40-70 years No acute respiratory infection in the past 4 weeks No changes in baseline medications in the past month Willingness to participate and sign informed consent

Exclusion criteria

Exclusion criteria: Severe asthma or bronchiectasis unrelated to chemical injury Class III or IV heart failure according to New York Heart Association criteria Renal failure Advanced liver disease Uncontrolled hypertension History of allergic reaction to hypertonic sodium chloride (7%) Tobacco/waterpipe use within the past 6 months Regular alcohol consumption Severe cognitive impairment Current ICU admission or requirement for mechanical ventilation Unwillingness to participate or sign informed consent

Design outcomes

Primary

MeasureTime frame
Forced Expiratory Volume in 1 second (FEV1). Timepoint: Weeks 0, 4, and 8 post-intervention. Method of measurement: Standard spirometry using calibrated equipment.;Respiratory Quality of Life Questionnaire Total Score. Timepoint: Weeks 0 and 8 post-intervention. Method of measurement: St. George Respiratory Quality of Life Questionnaire.;Serum C-reactive protein (CRP) level. Timepoint: Weeks 0 and 8 post-intervention. Method of measurement: ELISA using standardized kits.

Secondary

MeasureTime frame
Forced Vital Capacity (FVC). Timepoint: Weeks 0, 4, and 8 after intervention. Method of measurement: Standard spirometry using calibrated equipment.;Peak Expiratory Flow (PEF). Timepoint: Weeks 0, 4, and 8 after intervention. Method of measurement: Spirometry.;Frequency of coughing episodes. Timepoint: Weeks 0, 4, and 8 after intervention. Method of measurement: Patient-reported daily diary (visual analog scale).;Sputum production volume. Timepoint: Days 1 and 3, weeks 0, 4, and 8 after intervention. Method of measurement: Graded container measurement (morning collection).;Dyspnea. Timepoint: Weeks 0 and 8 after intervention. Method of measurement: Revised Medical Research Council Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMansoureh Molaei

Bagheiat-allah University of Medical Sciences

mollaeimansoure5@gmail.com+98 21 8804 0060

Outcome results

None listed

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