Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000179437
Ethics application status
Approved
Date submitted
19/03/2007
Date registered
22/03/2007
Date last updated
22/03/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of atorvastatin on lung function and morbidity as add-on therapy in asthmatic patients. A double-blind randomized cross-over trial.
Scientific title
The effect of atorvastatin on lung function and morbidity as add-on therapy in normolipid asthmatic patients. A double-blind placebo controlled randomized cross-over trial.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate to severe persistent asthma 1697 0
Condition category
Condition code
Respiratory 1789 1789 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
atorvastatin 10 mg per day oral for one month or placebo oral for one month, each therapy separated with 2 weeks wash out period (cross-over)
Intervention code [1] 1657 0
Treatment: Drugs
Comparator / control treatment
Placebo oral for one month,
Control group
Placebo

Outcomes
Primary outcome [1] 2504 0
Changes in Forced Expiratory Volume in one second (FEV1)
Timepoint [1] 2504 0
At baseline and after 4 weeks of each intervention (placebo or atorvastatin therapy)
Primary outcome [2] 2505 0
Changes in Forced Vital Capacity (FVC)
Timepoint [2] 2505 0
At baseline and after 4 weeks of each intervention (placebo or atorvastatin therapy)
Primary outcome [3] 2506 0
Changes in Peak Expiratory Flow (PEF)
Timepoint [3] 2506 0
At baseline and after 4 weeks of each intervention (placebo or atorvastatin therapy)
Secondary outcome [1] 4318 0
Changes in score of Jones Index of Morbidity
Timepoint [1] 4318 0
At baseline and after 4 weeks of each intervention (placebo or atorvastatin therapy).

Eligibility
Key inclusion criteria
Persistent moderate to severe asthma
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Dyslipidemia, adverse effect due to atorvastatin, other comorbid condition (heart failure, diabetes, MI, hypertension), receiving medication(s) interact with atorvastatin.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation concealed by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
the people receiving the treatment/s (subjects), the clinician administering the treatment/s, the researcher assessing the outcomes are blinded in the study
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
17
Accrual to date
Final
Recruitment outside Australia
Country [1] 493 0
Iran, Islamic Republic Of
State/province [1] 493 0

Funding & Sponsors
Funding source category [1] 1940 0
Government body
Name [1] 1940 0
National Research Institute of Tuberculosis and Lung Disease
Country [1] 1940 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Shaheed Beheshti University of Medical Sciences, Iran
Address
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 1751 0
Hospital
Name [1] 1751 0
Masih Daneshvari Hospital, Iran
Address [1] 1751 0
Country [1] 1751 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3618 0
Masih Daneshvari Hospital, NRITLD
Ethics committee address [1] 3618 0
Ethics committee country [1] 3618 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 3618 0
Approval date [1] 3618 0
20/10/2006
Ethics approval number [1] 3618 0
500

Summary
Brief summary
The main goal of the study was to assess the effects of atorvastatin on asthma as an inflammatory disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27760 0
Address 27760 0
Country 27760 0
Phone 27760 0
Fax 27760 0
Email 27760 0
Contact person for public queries
Name 10846 0
Fanak Fahimi
Address 10846 0
Masih Daneshvari Hospital, Shaheed Bahonar Ave, Darabad,
TEHRAN 19569, P.O: 19575/154
Country 10846 0
Iran, Islamic Republic Of
Phone 10846 0
+98 912 1940902
Fax 10846 0
+98 21 22678090
Email 10846 0
[email protected]
Contact person for scientific queries
Name 1774 0
Fanak Fahimi
Address 1774 0
Masih Daneshvari Hospital
Shaheed Bahonar Ave
Darabad
Tehran 19569
P.O: 19575/154
Country 1774 0
Iran, Islamic Republic Of
Phone 1774 0
+98 912 1940902
Fax 1774 0
Email 1774 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.