The aim of this this study is evaluation of the effect of Atrovastatin on inflammatory markers in sulfur mutsard gas induced chronic bronchitis. This is a single center, double blind randomized phase III clinical trial. The main inclusion criteria are exposure to mustard gas during the Iran-Iraq war and suffering from chronic bronchitis (history of chronic cough and sputum daily for 3 months during recent 2 years). The main exclusion criteria are using statin in the last 3 months; exacerbation of symptoms in the past 4 weeks; and smoking. We will enroll 90 patients with mustard gas induced chronic bronchitis. Participants will randomly be assigned into intervention and control groups and will receive Atorvastatin (40 mg per day) and placebo (one tablet per day) respectively for 3 months. As the primary outcome of our study, the level of IL 6, TNFa, procalcitonin, and hs-CRPwill be measured before and after intervention. We will compare the results between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904144312N1
Registration date:2014-08-16, 1393/05/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-16, 1393/05/25
Registrant information
Name
Seyed Masoom Masoompour
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4316
Email address
masoomm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Partly by Shiraz University of Medical Sciences and partly by Project Director will be provided
Expected recruitment start date
2014-06-29, 1393/04/08
Expected recruitment end date
2015-06-29, 1394/04/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Atrovastatin on inflammatory markers in sulfur mutsard gas induced chronic bronchitis
Public title
Effect of Atrovastatin on lung inflammation in bronchitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: exposure to mustard gas during the Iran-Iraq war and have suffered from chronic bronchitis (history of chronic cough and sputum daily for 3 months during recent 2 years)
Exclusion criteria: Using statin in the last 3 months of study starting time; exacerbation of symptoms in the past 4 weeks; connective tissue disease; sarcoidosis; eosinophilic granuloma; pneumoconiosis; lymphoma; carcinomatous; smokers
Age
From 45 years old to 75 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Headquarters Of Shiraz University of Medical Sciences - Zand St - Shiraz
City
Shiraz
Postal code
Approval date
2014-06-28, 1393/04/07
Ethics committee reference number
CT-P-9378-7109
Health conditions studied
1
Description of health condition studied
Chronic bronchitis
ICD-10 code
j44
ICD-10 code description
Chronic bronchitis: obstructive
Primary outcomes
1
Description
TNF alpha level
Timepoint
before intervention - 3 month after intervention
Method of measurement
ELISA test is performed
2
Description
interleukin 6 level
Timepoint
before intervention - 3 month after intervention
Method of measurement
ELISA test is performed
3
Description
Added at 2015-08-05: Procalcitonin
Timepoint
Added at 2015-08-05: At the beginning of the intervention and 3 months after intervention
Method of measurement
Added at 2015-08-05: ELISA
Secondary outcomes
1
Description
Withe blood cell count
Timepoint
before intervention - 3 month after intervention
Method of measurement
Complete Blood Count
2
Description
Added at 2015-08-05: hs-CRP
Timepoint
Added at 2015-08-05: At the beginning the intervention and 3 months after intervention
Method of measurement
Added at 2015-08-05: Immunoassay
Intervention groups
1
Description
Intervention group:40 mg atorvastatin daily for 3 months
Category
Treatment - Drugs
2
Description
Control group: one placebo tablet daily for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohammd Rasul allah Clinic
Full name of responsible person
Dr Seyed Masoom Masoompour
Street address
Pasdarn Blvd, Shiraz
City
shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
shiraz University Of medical Science
Full name of responsible person
Dr Seyed Baser Hashemi
Street address
Building of Shiraz University of Medical Sciences, 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
shiraz University Of medical Science
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
Dr seyed Masoom Masoompour
Position
Associate professor
Other areas of specialty/work
Street address
Internal Medicine Department, Nemazee Hospital, Nemazee Squ
City
Shiraz
Postal code
Phone
+98 71 1647 4316
Fax
+98 71 1647 4316
Email
masoomm@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
seyed Masoom Masoompour
Position
Associate Professor
Other areas of specialty/work
Street address
Internal Medicine Department, Nemazee Hospital, Nemazee Squ
City
shiraz
Postal code
Phone
+98 71 1647 4316
Fax
+98 71 1647 4316
Email
masoomm@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
Dr Seyed Masoom Masoompour
Position
Associate Professor
Other areas of specialty/work
Street address
Internal Medicine Department, Nemazee hospital, Nemazee Squ
City
Shiraz
Postal code
Phone
+98 71 1647 4316
Fax
+98 987116474316
Email
masoomm@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)