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Effects of atorvastatin on lung function in asthmatic patients under treatment with high dose inhaled steroid or oral steroid

Protocol summary

Summary
Objective: To evaluate the effect of atorvastatin on lung function in asthmatic patients under treatment with high dose inhaled steroid or oral steroid Methods: Sixty seven patients with moderate to severe asthma were entered in an eight-week triple blind randomized controlled trial comparing the effect of oral atorvastatin 40 mg daily with a matched placebo on lung function, airway inflammation and the level of asthma control. Patients spirometric features (FEV1, FVC, FEV1 /FVC, FEF 25-75%), inflammatory biomarkers (ESR, hs-CRP) and asthma control questionnaire scores were measured every 4 weeks during the course. Fifty patients completed the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138903114085N1
Registration date:
Registration timing: na

Last update:
Update count: 0
Registration date
empty
Registrant information
Name
Sayeh Heidari nejad
Name of organization / entity
Guilan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1554 1001
Email address
rrc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Guilan university of medical sciences
Expected recruitment start date
2008-02-20, 1386/12/01
Expected recruitment end date
2008-10-06, 1387/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of atorvastatin on lung function in asthmatic patients under treatment with high dose inhaled steroid or oral steroid
Public title
Effects of atorvastatin on asthmatic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aged 18 to 70 years, moderate to severe persistent asthma, under maintenance therapy with high dose inhaled corticosteroid and any dose of oral corticosteroid, under stable medication for the four preceding weeks before randomization, being admitted to respiratory clinic of Razi medical center (Rasht, Guilan province) Exclusion criteria: current smoking or ex-smoking more than 5 pack–year, pregnancy, lactation, any associated diseases, receiving statins or any statin interacting drugs, occurrence of any asthmatic attack during the study
Age
From 18 years old to 70 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice-chancellor for Research, Guilan university of medical sciences
Street address
Vice-chancellor for Research building, Shahid Siadati street, Namjoo avenue,
City
Rasht
Postal code
41446-68164
Approval date
2007-05-21, 1386/02/31
Ethics committee reference number
1680

Health conditions studied

1

Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma

Primary outcomes

1

Description
FEV1
Timepoint
at the begining of the study and every 1 month interval until 2 months
Method of measurement
spirometry

2

Description
FVC
Timepoint
at the begining of the study and every 1 month interval until 2 months
Method of measurement
spirometry

3

Description
FEV1/FVC
Timepoint
at the begining of the study and every 1 month interval until 2 months
Method of measurement
spirometry

4

Description
FEF25-75%
Timepoint
at the begining of the study and every 1 month interval until 2 months
Method of measurement
spirometry

5

Description
hs-CRP
Timepoint
at the begining of the study and every 1 month interval until 2 months
Method of measurement
blood sample,micg/ml

6

Description
ESR
Timepoint
at the begining of the study and every 1 month interval until 2 months
Method of measurement
blood sample, mm/h

7

Description
asthma control level
Timepoint
at the begining of the study and every 1 month interval until 2 months
Method of measurement
asthma control test (ACT)

Secondary outcomes

1

Description
creatinine kinase(CPK)
Timepoint
at the begining of the study and every 1 month interval until 2 months
Method of measurement
blood sample, IU/L

2

Description
liver function test
Timepoint
at the begining of the study and every 1-month interval until 2months
Method of measurement
blood sample,IU/L

3

Description
(Beta hCG) pregnancy test
Timepoint
at the begining of the study and every 1 month interval until 2 months
Method of measurement
blood sample, mIU/ml

Intervention groups

1

Description
Atrovastatin 40mg tablet, daily, for 8 weeks
Category
Treatment - Drugs

2

Description
Placebo 40mg tablet, daily, for 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Seyyed Ali Alavi Foumani
Street address
Sardar Jangal street
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research assistant of Guilan University of Medical Science
Full name of responsible person
Dr Abdolrasool Sobhani
Street address
Shahid siadati street, Namjoo avenue
City
Rasht
Grant name
124-610
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research assistant of Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Seyyed Ali Alavi Foumani
Position
Assistant professor / MD
Other areas of specialty/work
Street address
Sardar Jangal street, Razi hospital
City
Rasht
Postal code
41448-95655
Phone
+98 13 1554 1001
Fax
+98 13 1553 0169
Email
rrc@gums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Fatemeh Nejatifar
Position
MD
Other areas of specialty/work
Street address
Razi hospital, Sardar Jangal street
City
Rasht
Postal code
41448-95655
Phone
+98 13 1554 1001
Fax
+98 13 1553 0169
Email
dr_f_nejatifar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Sayeh Heidari Nejad
Position
MD
Other areas of specialty/work
Street address
Razi hospital, Sardar Jangal street
City
Rasht
Postal code
41448-95655
Phone
+98 13 1554 1001
Fax
+98 13 1553 0169
Email
sayeh.h1360@gmail.com
Web page address

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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