(1) Objectives: The aim of this study was to determine the effect of treatment with atorvastatin on serum levels of periostin and interleukin 13 compared with placebo in patients with asthma. (2) Design: Double-blind, randomized, placebo-controlled, phase 3 clinical trial (3) Setting and conduct: Patients are randomly divided into two groups of 40, and after obtaining informed consent, they are included in the study. Researchers are blind to patient and control allocation. 4) Participants: Major inclusion criteria: Patients with chronic asthma symptoms of more than one year duration, aged 18-60 years are enrolled. Major exclusion criteria: lower respiratory tract infection 4 weeks before entering the study; more than 10 pack-year of smoking; pregnancy or breastfeeding; current use of statins or drugs that interaction with statins. (5) Interventions: The intervention group treat with atorvastatin 40 mg once daily for 8 weeks, while the control group receive placebo. Asthma controller therapies do not change. (6) Main outcome variables: serum levels of periostin and serum levels of interleukin.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017102216367N2
Registration date:2017-11-15, 1396/08/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-11-15, 1396/08/24
Registrant information
Name
Samrad Mehrabi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4316
Email address
mehrabis@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-05-21, 1397/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of treatment with atorvastatin on serum levels of periostin and interleukin 13 comapred with placebo in asthmatic patients
Public title
Effect of treatment with atorvastatin on asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Asthma patients with a history of more than one year, aged 18 till 60 years are enrolled. Exclusion criteria: Lower respiratory infection 4 weeks before entering the study; more than 10 pack-year of smoking or smoking in the last 3 months; pregnancy or breastfeeding; current use of statins or previous side effects of statin or drugs that interact with statins such as antifungal, antibiotic macrolide, cyclosporine, germifibrosil, verapamil and amiodarone; hepatitis or active liver disease; myopathy or myositis.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Postal code
14336 - 71348
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
15216
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45.8
ICD-10 code description
Mixed Asthma
Primary outcomes
1
Description
Serum level of periostin
Timepoint
Befor intervention and eight weeks after intervention
Method of measurement
ng/mL
2
Description
Serum level of IL-13
Timepoint
Befor intervention and eight weeks after intervention
Method of measurement
pg/mL
Secondary outcomes
1
Description
Adverse drug/placebo reaction
Timepoint
4 and 8 weeks after intervention
Method of measurement
Ask from the patient and laboratory data
2
Description
Forced expiratory volume in first second
Timepoint
Before intervention and 4 and 8 weeks later
Method of measurement
liters per minute
Intervention groups
1
Description
Intervention group: Tablets of َAtorvastatin are product of IRAN and 40 mg. Therapy is with one tablet daily for eight weeks.
Category
Treatment - Drugs
2
Description
Control group: Placebo will be given 1 times daily for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Lung clinic
Full name of responsible person
Samrad Mehrabi
Street address
Motahhari clinic, Namazi Sq
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, 7th floor, Central building of SUMS, Zand Ave
Full name of responsible person
Seyed Basir Hashemi
Street address
Vice chancellor for research, 7th floor, Central building of SUMS, Zand Ave
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 7th floor, Central building of SUMS, Zand Ave
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Samrad Mehrabi
Position
Assistant professor of medicine
Other areas of specialty/work
Street address
Department of internal medicine, Namazi hospital, Namazi Sq
City
Shiraz
Postal code
Phone
+98 71 3647 4316
Fax
Email
mehrabis@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Samrad Mehrabi
Position
Assistant professor of medicine
Other areas of specialty/work
Street address
Department of Internal Medicine, Namazi hospital, Namazi Sq
City
Shiraz
Postal code
Phone
+98 71 3647 4316
Fax
Email
mehrabis@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Samrad Mehrabi
Position
Assistant professor of medicine
Other areas of specialty/work
Street address
Department of internal medicine, Namazi hospital,Nanazi Sq
City
Shiraz
Postal code
Phone
+98 71 3647 4316
Fax
Email
mehrabis@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)