The effect of Montelukast on respiratory complications detected in patients with multiple trauma and lung injury

A study to evaluate the effect of Montelukast tablets on respiratory complications in patients with multiple trauma suffering from lung injury; a double blind randomized clinical trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190719044270N1

Enrollment

Registered

2019-11-08

Start date

2019-09-23

Completion date

Unknown

Last updated

2019-12-17

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

Conditions

Condition 1: Contusion of lung. Condition 2: Multiple fractures of ribs. Condition 3: Acute respiratory distress syndrome. Condition 4: Pneumonia. Condition 5: Pulmonary embolism. Contusion of lung Multiple fractures of ribs Acute respiratory distress syndrome Streptococcus pneumoniae as the cause of diseases classified elsewhere Pulmonary embolism

Interventions

Intervention 1: Intervention group: Airokast® (Montelukast -as sodium- Abidi company) 10 mg Orally, Once daily for 7 days. Intervention 2: Control group: Placebo pills (Produced in the Faculty of Phar

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with blunt multiple trauma and at least 3 fractured ribs Patients with blunt multiple trauma and lung contusion detected in CT scan performed on arrival

Exclusion criteria

Exclusion criteria: Patients younger than 16 years Patients with penetrating trauma Patients with history of cardiopulmonary disease Patients with history of hypersensitivity to Montelukast Patients who will not sign the informed written consent

Design outcomes

Primary

Measure	Time frame
Lung contusion. Timepoint: on day 0 and 7. Method of measurement: Chest CT-scan.;Acute Lung Injury. Timepoint: on day 7. Method of measurement: Chest CT-scan.;Acute Respiratory Distress Syndrome. Timepoint: on day 7. Method of measurement: Chest CT-scan.;Pulmonary Emboli. Timepoint: on day 7. Method of measurement: Chest CT angiography.;Pneumonia. Timepoint: on day 7. Method of measurement: Chest CTscan.	—

Measure

Time frame

Lung contusion. Timepoint: on day 0 and 7. Method of measurement: Chest CT-scan.;Acute Lung Injury. Timepoint: on day 7. Method of measurement: Chest CT-scan.;Acute Respiratory Distress Syndrome. Timepoint: on day 7. Method of measurement: Chest CT-scan.;Pulmonary Emboli. Timepoint: on day 7. Method of measurement: Chest CT angiography.;Pneumonia. Timepoint: on day 7. Method of measurement: Chest CTscan.

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Secondary

Measure	Time frame
C reactive Protein. Timepoint: day 0 and 3. Method of measurement: Serum agglutination test.;Procalcitonin. Timepoint: day 3. Method of measurement: Blood level of procalcitonin.;Length of ICU stay. Timepoint: Discharge from ICU. Method of measurement: counting ICU admission days.;Days underwent ventilator assisted respiration. Timepoint: on discharge. Method of measurement: counting the days underwent ventilator assisted respiration.	—

Measure

Time frame

C reactive Protein. Timepoint: day 0 and 3. Method of measurement: Serum agglutination test.;Procalcitonin. Timepoint: day 3. Method of measurement: Blood level of procalcitonin.;Length of ICU stay. Timepoint: Discharge from ICU. Method of measurement: counting ICU admission days.;Days underwent ventilator assisted respiration. Timepoint: on discharge. Method of measurement: counting the days underwent ventilator assisted respiration.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Taheri Akerdi

Bagheiat-allah University of Medical Sciences

ata110iran@gmail.com+98 71 3625 4206

Outcome results

None listed

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