Protocol summary

Summary
High sensitive CRP is used as a marker of systemic inflammation in pulmonary disease. Results have shown an anti-inflammatory effect of atorvastatin in cardiopulmonary disease. Thus, this study was undertaken to assess the effect of atorvastatin on serum hs-CRP in chemical warfare victims. We studied 50 patients with mustard lung injury and high serum level of hs-CRP in a double blind, prospective study from Feb., 2011 to Dec., 2011 in Emam Khomeini Hospital, Ardabil, IRAN. Chemical warfare victims with pulmonary disease, who fulfilled entry criteria, were invited to participate in this study. Demographic data (height, weight, body mass index, blood pressure, drug history), COPD assessment test and St. George respiratory questionnaire are completed by patients. Then, pulseoximetry, spirometry and 6 minute walk distance tests are administered. Blood sample is drawn for serum hs-CRP level analysis. Coded pockets (from 1 to 50) containing atorvastatin and placebo (A or B codes) are randomly assigned by a nurse to the patients and the control groups (double blind). 40 mg atorvastatin tablets and the placebo are prescribed once daily for 9 weeks. After 4 weeks of intervention complete examination, pulseoximetry, spirometry and drug side effects are conducted by physician. At the end of the 9th weeks, physical examination, spirometry, pulseoximetry, St. George respiratory questionnaire, 6 minute walk distance test and blood sampling for hs-CRP will be conducted. It should be mentioned that, the patients are informed about the study and in the case of full written consult they are entered in the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201101095579N1
Registration date: 2011-11-13, 1390/08/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-11-13, 1390/08/22
Registrant information
Name
Hassan Ghobadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3325 1401
Email address
h.ghobadi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University Of Medical Sciences
Expected recruitment start date
2011-02-04, 1389/11/15
Expected recruitment end date
2011-12-06, 1390/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Atorvastatin effect on lung function and serum level of hs-CRP in chemical warfare patients with obstructive pulmonary disease.
Public title
Aatorvastatin effect on lung function and serum level of hs-CRP in chemical warfare patients with obstructive pulmonary disease.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Chemical warfare victims with obstructive pulmonary disease; age between 35-85; clinically stable disease in previous 8 weeks; acceptance of study design by patients. Exclusion criteria: Active infectious disease; bronchiectasis; chronic inflammatory diseases; soft tissue diseases; active liver and kidney diseases; cancer; cardiac disease (myocardial infarction and unstable angina in previous 6 months); sensitivity to atorvastatin; myopathy; myositis; hypercholestrolemia history; history of atorvastatin consumption; history of smoking; asthma; elevated CPK and elevated liver function test more than twice.
Age
From 35 years old to 85 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
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
Ardabil University Of Medical Sciences
Street address
Ardabil University Of Medical Sciences, Daneshgah street
City
Ardabil
Postal code
56198-53141
Approval date
2011-09-08, 1390/06/17
Ethics committee reference number
6/902

Health conditions studied

1

Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
(J00-J99)
ICD-10 code description
Chronic lower respiratory diseases

Primary outcomes

1

Description
COPD Assessment Test (CAT) questionnaire
Timepoint
At the beginning of study and 9 weeks after intervention
Method of measurement
CAT questionnaire score (score from 0 to 40)

2

Description
Six Minute Walk Distance Test (6MWDT)
Timepoint
At the beginning of study, 4 weeks and 9 weeks after intervention
Method of measurement
Distance walked in six minute (Meter)

3

Description
Pulmonary volumes
Timepoint
At the beginning of study, 4 weeks and 9 weeks after intervention
Method of measurement
Spirometry

4

Description
The level of hs-CRP
Timepoint
At the beginnig of study and 9 weeks after intervention
Method of measurement
Laboratory

5

Description
St. George Respiratory Questionnaire
Timepoint
At the beginning of study and 9 weeks after intervention
Method of measurement
The questionnaire of assessing symptoms score, activity score, impact score and total score

Secondary outcomes

1

Description
O2 saturation of arterial blood
Timepoint
At the beginning of study, 4 weeks and 9 weeks after intervention
Method of measurement
Pulse oximetry device

2

Description
Atorvastatin side effects
Timepoint
4 weeks and 9 weeks after intervention
Method of measurement
According to patient symptoms

Intervention groups

1

Description
In intervention group: Atorvastatin, 40 mg tablet, once daily for 9 weeks
Category
Treatment - Drugs

2

Description
In control group: The placebo tablet, once daily for 9 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Pulmonary Clinics Of Emam Khomeini Hospital, Ardabil
Full name of responsible person
Afsoun Mahmoudpour, Internal medicine resident
Street address
Emam Khomeini Hospital, Shahid Jeddi street, Ardabil
City
Ardabil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ardabil University Of Medical Sciences
Full name of responsible person
Vice-president for research affair
Street address
Ardabil University Of Medical Sciences, Daneshgah street
City
Ardabil
Grant name
1290007
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University Of Medical Sciences
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
Ardabil University Of Medical Sciences
Full name of responsible person
Afsoun Mahmoudpour
Position
Internal medicine resident
Other areas of specialty/work
Street address
Ardabil University Of Medical Sciences, Daneshgah street
City
Ardabil
Postal code
56198-53141
Phone
+98 45 1551 2006
Fax
+98 45 1551 0057
Email
Mahmoudpour.afsoun@gmail.com
Web page address
Http : //medicine.arums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University Of Medical Sciences
Full name of responsible person
Hassan Ghobadi Marallu
Position
Pulmonologist, Internal Medicine Department
Other areas of specialty/work
Street address
Ardabil University Of Medical Sciences, Daneshgah street
City
Ardabil
Postal code
56198-53141
Phone
+98 45 1551 2006
Fax
+98 45 1551 0057
Email
h.ghobadi@arums.ac.ir
Web page address
Http : // medicine.arums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University Of Medical Sciences
Full name of responsible person
Hassan Ghobadi Marallu
Position
Pulmonologist, Internal Medicine Department
Other areas of specialty/work
Street address
Ardabil University Of Medical Sciences, Daneshgah street
City
Ardabil
Postal code
56198-53141
Phone
+98 45 1551 2006
Fax
+98 45 1551 0057
Email
h.ghobadi@arums.ac.ir
Web page address
Http : //medicine.arums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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