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Comparison effects of Itraconazole and Prednisone in patients with persistent severe asthma

Comparison effects of Itraconazole and Prednisone on Fibroblast Growth Factor 2 gene expression, clinical manifestation and other tests in patients with persistent severe asthma

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181225042116N1
Enrollment
70
Registered
2020-12-18
Start date
2020-12-21
Completion date
Unknown
Last updated
2021-01-05

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: The first intervention group: Itraconazole capsules 100 mg twice a day for 8 months Tehran Daru company. Intervention 2: Control group: prednisone tablets 5 mg twice a day for 8 month

Sponsors

Islamic Azad University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age older than 18 years old No response to high dose inhaled corticosteroids and long acting beta agonist with antileukotriene Forced expiratory volume in one second less than 80 percent Fungal sensitization

Exclusion criteria

Exclusion criteria: Sensitivity and drug interaction with Itraconazole History of taking Itraconazole Gastroesophageal reflux disease Known and untreated Severe heart disease Known liver and kidney disease Chronic eosinophilic pneumonia Charge Strauss syndrome Chronic Obstructive Pulmonary Disease Total IgE more than 1000IU/ml Pregnancy or breastfeeding Lack of access to Appropriate RNA in patient sputum sample Sarcoidosis Hypersensitivity pneumonitis Impaired vocal cords Filarisis Central airway obstruction Sleep apnea

Design outcomes

Primary

MeasureTime frame
Fibroblast growth factor2 gene expression measurement. Timepoint: Measuring fibroblast growth factor 2 gene expression before intervention and 8 months after taking Itraconazole drug or prednisone. Method of measurement: Real time Polymerase Chain Reaction.;Number of sputum eosinophils and neutrophils. Timepoint: Before intervention and 8 months after treatment. Method of measurement: Preparation of thin smear after sputum centrifugation with DDT 0.01%, and staining with hematoxin and eosin and counting with light microscope.;Bronchial size changes include bronchial thickness, internal lumen, external lumen, wall area percentage. Timepoint: Before intervention and 8 months after treatment. Method of measurement: Chest High-resolution computed tomography.;Spirometric parameters include FEV1, FVC, Fef25-75. Timepoint: Before intervention and 8 months after treatment. Method of measurement: Spirometer device.

Secondary

MeasureTime frame
Measurement of fractional nitric oxide concentration in exhaled breath. Timepoint: Before the intervention and after 8 months of treatment. Method of measurement: Bedfont NO breath device for Measuring nitric oxide.;Asthma Symptom Questionnaire. Timepoint: Before the intervention and after 8 months of treatment. Method of measurement: Asthma control questionnaire (ACQ).;Clinical symptoms of patients include wheezing. Timepoint: Before the intervention and after 2 weeks, then every month until the end of the treatment period. Method of measurement: According to the examination by stethoscope.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahsa Manafi Varkiani

Islamic Azad University

mahsafall_2005@yahoo.com+98 51 3605 5216

Outcome results

None listed

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