Protocol summary

Summary
This study is a randomized double blind clinical trials will be conducted on 62 asthmatic patients (intervention and control group, each 31 cases) the inclusion criteria included patients with mild persistent to moderate persistent asthma (grade 2 and 3 criteria, the severity of asthma) and exclusion criteria included pregnancy, people which currently taking statin drugs, history of sensitivity to statin drugs, history of hospitalization during the last month, smokers, history of hepatitis or active liver disease, myopathy or myositis. intervention Group treated with atorvastatin tablets 40 mg oral daily dose for 8 weeks and control group during this period will receive placebo. At the onset of the study after obtaining informed consent, the standard questionnaire of asthma control test (ACT ) will be filled out by patients followed by a spirometry. A blood sample to measure the number of peripheral blood eosinophil, serum low-density lipoprotein, high density lipoprotein, total cholesterol and triglycerides are taken from the patient. Four weeks after the treatment of asthma, control questionnaire will be complete again and re-matched patients with possible side effects of the drugs and asthma control level. Finally, after eight weeks of treatment, again filling the questionnaire asthma control and Spirometry is taken from patients. blood samples to determine changes in the number peripheral blood eosinophil, serum total cholesterol and triglyceride is taken. The expected primary outcome was improve the degree of control of clinical asthma symptoms based on the asthma controlled test (ACT) Expected secondary outcomes include to improve pulmonary volumes [percent of forced expiratory volume in one second (% 1FEV) and percentage of vital capacity (% FVC)] and decrease the number of peripheral blood eosinophil. Maintenance treatment of asthmatic patients are not altered. At the begining and the end of the study to assess drug compliance of the patients, Serum cholesterol and TG measurement tests will be done.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201104236257N1
Registration date: 2011-05-25, 1390/03/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-05-25, 1390/03/04
Registrant information
Name
Abdollatif Moini
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1221 5812
Email address
dr.moini@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2010-10-24, 1389/08/02
Expected recruitment end date
2011-04-10, 1390/01/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Atrvastatyn effect in treating patients with asthma
Public title
Effect of statins in treating patients with asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included: patients with mild persistent to moderate persistent asthma (grade 2 and 3 criteria, the severity of asthma), age 18 to 70 years and acceptance of written consent. Exclusion criteria included: pregnancy, people who currently are taking statin drugs , history of sensitivity to statin drugs, History of hospitalization during a month before the research, smokers, history of hepatitis or active liver disease ,myopathy or myositis
Age
From 18 years old to 70 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 31
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
Medical Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences
City
Arak
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
3-40-87

Health conditions studied

1

Description of health condition studied
Asthma
ICD-10 code
J45.9
ICD-10 code description
Asthma, unspecified

Primary outcomes

1

Description
The expected primary outcome was improvement in the degree of clinical control of asthma symptoms [base on standardized Asthma Control Test (ACT)]
Timepoint
At the onset of the study and 8 week after treatment with atorvastatin
Method of measurement
base on standardized Asthma Control Test (ACT)

Secondary outcomes

1

Description
Secondary outcomes included lung volumes [percent of forced expiratory volume in one second (FEV1 %) and percent of forced vital capacity (FVC%)] and reduction of the number of peripheral blood eosinophils
Timepoint
At the onset of the study and 8 week after treatment with atorvastatin
Method of measurement
spirometry and peripheral blood sample

Intervention groups

1

Description
31 patients were selected as intervention group and treat with atorvastatin tablets (by: Sobhan Pharmaceutical Company) 40 milligram daily for 8 weeks . At the begining of the study after obtaining formal consent, the standard questionnaire of asthma control test (ACT) is filled out and followed by a spirometry; also a peripheral blood sample is taken to measure blood eosinophil counts and patients’ serum low density lipoprotein-cholesterol(LDL-C), low density lipoprotein-cholesterol (HDL-C), total cholesterol, and TG levels. Serum cholesterol and TG measurement tests is applyied to evaluate the adherence of the patients. For spiromety, Desktop spirometer device, Pony FX model, made in Italy is used. Four weeks after treatment,asthma control test (ACT) questionnaire will be re-administered and the patients visit for possible side effects of drugs and asthma control level. Finally, after 8 weeks of treatment, the patiants took the asthma control test (ACT) questionnaire, and a spirometry is taken from patients. Also, another peripheral blood sample is taken to determine changes in the peripheral blood eosinophil count and serum cholesterol and TG levels.
Category
Treatment - Drugs

2

Description
31 patients were selected as Control group and receive placebo daily for 8 weeks . At the begining of the study after obtaining formal consent, the standard questionnaire of asthma control test (ACT) is filled out and followed by a spirometry; also a peripheral blood sample is taken to measure blood eosinophil counts and patients’ serum low density lipoprotein-cholesterol(LDL-C), low density lipoprotein-cholesterol (HDL-C), total cholesterol, and TG levels. For spiromety, Desktop spirometer device, Pony FX model, made in Italy is used. Four weeks after treatment,asthma control test (ACT) questionnaire will be re-administered and the patients visit for asthma control level. Finally, after 8 weeks of treatment, the patiants took the asthma control test (ACT) questionnaire, and a spirometry is taken from patients. Also, another peripheral blood sample is taken to determine changes in the peripheral blood eosinophil count and serum cholesterol and TG levels
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir-almomenin Hospital
Full name of responsible person
Abdollatif Moini
Street address
Arak, Amir-almomenin Hospital
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Said Changhizi Ashtiani
Street address
Arak University of Medical Sciences, Deputy of Education & Research
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr. Abdollatif Moini
Position
pulmonologist, Assistant Professor
Other areas of specialty/work
Street address
Iran Internal Medicin Department of Amir-al-momenin Haspital
City
Arak
Postal code
Phone
+98 86 1222 5202
Fax
Email
dr.moini@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Abdollatif Moini
Position
pulmonologist, Assistant Professor
Other areas of specialty/work
Street address
internal Medicine Department of Amir-al-momenin Haspital- Arak- Iran
City
Arak
Postal code
Phone
+98 86 1222 5202
Fax
+98 86 1417 3630
Email
dr.moini@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Abdollatif Moini
Position
pulmonologist, Assistant Professor
Other areas of specialty/work
Street address
internal Medicine Department of Amir-al-momenin Haspital- Sardasht- Arak
City
Arak
Postal code
Phone
+98 86 1222 5202
Fax
Email
dr.moini@arakmu.ac.ir
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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