effect of Itraconazole in severe asthma

The effect of Itraconazole on airways remodeling in patients with severe refractory asthma

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20091111002695N9

Enrollment

Registered

2019-05-25

Start date

2019-06-10

Completion date

Unknown

Last updated

2019-08-26

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

Conditions

Severe persistent asthma. Severe persistent asthma

Interventions

Intervention 1: Intervention group 1: Itraconazole 100 mg in form of soft gelatin capsule, one each 12 hours, for 8 months. This drug is provided by Alborz Darou Company. Intervention 2: Intervention

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients suffering from severe refractory asthma who could not be controlled by high dose corticosteroids and Long acting beta2 agonists or by antileukotrienes with or without tiotropium. FEV1 should be less than 80 percent.

Exclusion criteria

Exclusion criteria: Allergic bronchopulmonary aspergillosis Drug allergy Pregnancy or Breast milk feeding Interstitial lung disease such as Vasculitis Recent lung infection Gastroesophageal reflux

Design outcomes

Primary

Measure	Time frame
Bronchial Wall thickness. Timepoint: ?Before intervention and 8 months after intervention. Method of measurement: Computed tomography(CT) Scan of lung.;Transforming growth factor beta (TGF-beta) gene expression in the sputum. Timepoint: Before intervention and 8 months after intervention. Method of measurement: Detecting by Polymerase chain reaction (PCR) of the Sputum.	—

Secondary

Measure	Time frame
Fraction of expiratory Nitric Oxide (FENO). Timepoint: Before intervention and 8 months after intervention. Method of measurement: Expiratory nitric oxide test with NObreath equipment.;Forced expiratory volume in one second (FEV1). Timepoint: Before intervention and 8 months after intervention. Method of measurement: Micro medical spirometer.;Asthma control. Timepoint: Before intervention and 8 months after intervention. Method of measurement: Asthma Control Test (ACT) score.;Number of Need for emergency services because of asthma exacerbation. Timepoint: Before intervention and 8 months after intervention. Method of measurement: Recording the date of asthma exacerbation in the Special Card which will be given to the patients.	—

Measure

Time frame

Fraction of expiratory Nitric Oxide (FENO). Timepoint: Before intervention and 8 months after intervention. Method of measurement: Expiratory nitric oxide test with NObreath equipment.;Forced expiratory volume in one second (FEV1). Timepoint: Before intervention and 8 months after intervention. Method of measurement: Micro medical spirometer.;Asthma control. Timepoint: Before intervention and 8 months after intervention. Method of measurement: Asthma Control Test (ACT) score.;Number of Need for emergency services because of asthma exacerbation. Timepoint: Before intervention and 8 months after intervention. Method of measurement: Recording the date of asthma exacerbation in the Special Card which will be given to the patients.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMajid Mirsadraei

Islamic Azad University

majidmirsadraee@mshdiau.ac.ir+98 51 3870 4347

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 10, 2026