Azathioprine effect in severe asthmatic patients

Comparison of the effectiveness of Azathioprine and placebo on lung volumes, exacerbations and severity of asthma in severe asthmatic patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231219060463N1

Enrollment

Registered

2024-01-16

Start date

2024-02-09

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Asthma. Severe persistent asthma

Interventions

Intervention 1: Intervention group: Azathioprine, 2mg/kg daily tablets for 3 months? made in Ramopharmin pharmaceutical company. Intervention 2: Control group: Palcebo, with the same size and shape as

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Severe asthmatic patients (FEV1<60) diagnosed by pulmonologist No improvement in symptoms with usual treatments for asthma including Prednisolone 5mg/day, High dose inhaled corticosteroid, Long acting beta agonist and Long acting muscarinic antagonist

Exclusion criteria

Exclusion criteria: Advanced liver failure Advanced renal failure Pregnancy Breastfeeding Cytopenia Moderate to severe anemia Known allergy to azathioprine Concomitant treatment with: Allopurinol, Febuxostat, Adalimumab, Anakinra Elevated liver enzymes (aminasemia)

Design outcomes

Primary

Measure	Time frame
Mean forced expiratory volume in second 1. Timepoint: Before intervention and three months after intervention. Method of measurement: Spirometry.;Mean Forced Vital Capacity (FVC). Timepoint: Before intervention and three months after intervention. Method of measurement: Spirometry.;Mean forced expiratory flow at 25–75% of forced vital capacity. Timepoint: Before intervention and three months after intervention. Method of measurement: Spirometry.;Mean asthma related questionnaire score. Timepoint: Before intervention and three months after intervention. Method of measurement: Asthma related questionnaire GSK 2002.;The number of exacerbations. Timepoint: before intervention and three months after intervention. Method of measurement: History taking.;Distance traveled in the 6-minute walking test. Timepoint: Before intervention and 3 months after intervention. Method of measurement: 6-minute walk test.;Relative frequency of asthma recovery based on the forced expiratory volume in 1 second. Timepoint: At the end of the study. Method of measurement: Spirometer.	—

Measure

Time frame

Mean forced expiratory volume in second 1. Timepoint: Before intervention and three months after intervention. Method of measurement: Spirometry.;Mean Forced Vital Capacity (FVC). Timepoint: Before intervention and three months after intervention. Method of measurement: Spirometry.;Mean forced expiratory flow at 25–75% of forced vital capacity. Timepoint: Before intervention and three months after intervention. Method of measurement: Spirometry.;Mean asthma related questionnaire score. Timepoint: Before intervention and three months after intervention. Method of measurement: Asthma related questionnaire GSK 2002.;The number of exacerbations. Timepoint: before intervention and three months after intervention. Method of measurement: History taking.;Distance traveled in the 6-minute walking test. Timepoint: Before intervention and 3 months after intervention. Method of measurement: 6-minute walk test.;Relative frequency of asthma recovery based on the forced expiratory volume in 1 second. Timepoint: At the end of the study. Method of measurement: Spirometer.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMostafa Ajaman

Ahvaz University of Medical Sciences

ajaman.m@ajums.ac.ir+98 61 3292 1839

Outcome results

None listed

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