Effect of new triazoles drugs on the treatment of severe resistant asthma, a randomized single blinded, active comparator clinical trial.
Phase 3
- Conditions
- Asthma.asthma , unspecified
- Registration Number
- IRCT201410032695N7
- Lead Sponsor
- Islamic Azad University- Mashhad Branch
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Patients who used asthma treatment according to GINA guidelines by stepwise approach including ICS, LABA, antileukotriens and theophylline (step 4) and still suffer from poor asthma; asthma interferences with normal daily activities; symptoms occur more than 2 days a week; sleep disorder induced by asthma more than 2 days a week; Needs Short Acting B2 Agonist (SABA) more than2 days a week; FEV1 < 80%; ACT score < 20
Exclusion criteria:
Acute or emergency attack of asthma; active infections other than fungal infections; contraindications to Azole drugs such as Sensitivity to drugs and Breastfeeding period; Interstitial lung disease such as vasculitis and churg strauss; Gasteroesophageal Reflux disease.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Asthma control test (ACT). Timepoint: At the beginning and 30 days after the treatment. Method of measurement: ACT questionnaire.;Fraction of expiratory Nitric Oxide (FENO). Timepoint: At the beginning of the study and after 30 days of treatment. Method of measurement: NO breath equipment.
- Secondary Outcome Measures
Name Time Method