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

Phase 2

Recruiting

• Conditions: Asthma.; Severe persistent asthma; J45.5

• Registration Number: IRCT20181225042116N1
• Lead Sponsor: Islamic Azad University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.