effect of Itraconazole in severe asthma
Phase 2
Recruiting
- Conditions
- Severe persistent asthma.Severe persistent asthmaJ45.5
- Registration Number
- IRCT20091111002695N9
- Lead Sponsor
- Islamic Azad University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 75
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
Allergic bronchopulmonary aspergillosis
Drug allergy
Pregnancy or Breast milk feeding
Interstitial lung disease such as Vasculitis
Recent lung infection
Gastroesophageal reflux
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.