Comparison effects of Itraconazole and Prednisone on Fibroblast Growth Factor 2 gene expression, clinical manifestation and other tests 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
Design
Interventional clinical trial in 2 - 3 phase with control group, design of 70 patients as a sample group, parallel groups, double blind, using permuted block randomization by STATََA software and concealed in numbered drug containers.
Settings and conduct
In pulmonary private office after filling questionnaire including asking about clinical manifestation and asthma control test, spirometry respiratory test, analyzing lung ct scan and rule out of other diseases, counting blood cells and being in definition of severe asthma as well, 70 randomized patients will participate in study after taking phlegm smear in two itraconazole and prednisone groups then after 32 weeks all tests will take again, blinding by numbered uniform drug containers that is not assignable for patients and office staff.
Participants/Inclusion and exclusion 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 with fungal sensitization.
Exclusion criteria: drug interaction or sensitivity to Itraconazole; pregnancy or breastfeeding periods; interstitial disease like vasculitis or churg strauss; severe heart disease; being smoker.
Intervention groups
In experimental group Itraconazole capsule 100 mg twice a day and in control group prednisone capsule 5mg twice a day with uniform containers and lable
Main outcome variables
Wheezing; decreasing Fgf2 expression; reducing the number of eosinophils and neutrophils in sputum; increasing spirometric parameters; decreased expiratory nitric oxide; increased bronchial diameter on CT scan
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181225042116N1
Registration date:2020-12-18, 1399/09/28
Registration timing:prospective
Last update:2020-12-18, 1399/09/28
Update count:0
Registration date
2020-12-18, 1399/09/28
Registrant information
Name
Mahsa Manafi Varkiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3605 5216
Email address
mahsafall_2005@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effects of Itraconazole and Prednisone on Fibroblast Growth Factor 2 gene expression, clinical manifestation and other tests in patients with persistent severe asthma
Public title
Comparison effects of Itraconazole and Prednisone in patients with persistent severe asthma
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of individuals to study groups is a block randomization method using 7 blocks of 10; This is done with stata software version 16, this software generates random groups, each block has 5 people in the intervention group and 5 people in the control group, whose order is also random and the numbers assigned to each person are different then labeled onto medicine boxes that have the same shape , and all ten drugs that belong to a block are placed in a separate package, and one is randomly picked and given to the patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
All drugs, both prednisone and itraconazole, have been purchased from the pharmaceutical company in the form of a pure white substance. Then, the drugs are filled in capsules of the same size and color with the cooperation of Mashhad School of Pharmacy; medicine cans are packed in the same shape with the same drug label, random numbers are pasted on them and placed in packs of 10 that are already divided into blocks, then these packages are transferred to a specialized asthma clinic.then nurse is given a can of medicine to the patient after the doctor's examination and being included in the criteria for studying.At the end of each course of the drug, the same can of medicine with the previous code is given again until the end of the study. Also, the person entering the information in Excel enters all the patient information only according to the code on the medicine. During the study, none of the people are aware of the type of medicine used. At the end of the study, the person who had no role in the study is asked to Assign 1 and 2 to the table of random numbers for each drug that can be analyzed for statistics without knowing the drug.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Central Organization of Islamic Azad University