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Effect of new triazoles drugs on the treatment of severe resistant asthma, a randomized single blinded, active comparator clinical trial.

Effect of new Tri-azoles anti-fungal drugs on clinical findings and radiological and physiological parameters of subjects suffering from severe resistant asthma. A randomized single blinded clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201410032695N7
Enrollment
40
Registered
2015-11-09
Start date
2015-06-01
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Asthma. asthma , unspecified

Interventions

Intervention 1: Patients referred for treatment will complete their therapy for asthma including ICS, LABA, antileukotriene and theophylline in stepwise approach according the GINA guideline for contr
Placebo
Treatment - Drugs
Patients referred for treatment will complete their therapy for asthma including ICS, LABA, antileukotriene and theophylline in stepwise approach according the GINA guideline for controlling the asthm

Sponsors

Islamic Azad University- Mashhad Branch
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Periostin. Timepoint: Before and after four months treatment. Method of measurement: ELIZA.;Dyspnea. Timepoint: At the beginning of the study and at the end of the 30 days treatment. Method of measurement: MMRC questionnaire.;Wheezing. Timepoint: At the beginning and 30 days after the treatment. Method of measurement: Auscultation / Physical examination.;Cough. Timepoint: At the beginning and 30 days after the treatment. Method of measurement: Questionnaire.;Forced expiratory volume in one second. Timepoint: At the beginning of the study and at the end of the 30 days treatment. Method of measurement: Spirometry.;Frequency of asthma symptoms requiring SABA use on a daily or near daily basis. Timepoint: At the beginning of the study and at the end of the 10 days treatment. Method of measurement: Questionnaire.;Blood eosinophil counts. Timepoint: At the beginning of the study 30 days after the treatment. Method of measurement: Blood cell count.;Serum IgE. Timepoint: Before and after the trial. Method of measurement: ELIZA.;IL-4. Timepoint: At the beginning and 30 days after the treatment. Method of measurement: ELIZA.;TGF-beta. Timepoint: At the beginning and 30 days after the treatment. Method of measurement: ELIZA.;PDGF. Timepoint: At the beginning and 30 days after the treatment. Method of measurement: ELIZA.;INF-gamma. Timepoint: At the beginning and 30 days after the treatment. Method of measurement: ELIZA.;IL-17. Timepoint: At the beginning and 30 days after the treatment. Method of measurement: ELIZA.;Bonchial wall thickness. Timepoint: At the beginning and 30 days after the treatment. Method of measurement: Computed tomography of lung.;Sputum eosinophil. Timepoint: At the beginning and 30 days after the treatment. Method of measurement: Sputum cytology.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMajid Mirsadraei

Islamic Azad University- Mashhad Branch

majidmirsadraee@mshdiau.ac.ir+98 51 3882 0417

Outcome results

None listed

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