Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000704291
Ethics application status
Approved
Date submitted
31/01/2009
Date registered
14/08/2009
Date last updated
15/12/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A placebo controlled clinical trial on the efficacy of atorvastatin 20 mg daily in patients with bronchial hyper-responsiveness.
Scientific title
A placebo controlled clinical trial on the efficacy of atorvastatin 20 mg daily administration for 4-6 weeks in patients with bronchial hyper-responsiveness.
Secondary ID [1] 273614 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bronchial hyper-responsiveness 4256 0
Condition category
Condition code
Respiratory 4478 4478 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Atorvastatin 20mg once daily will be administered orally for 4-6 weeks to all patients in the intervention group according to the clinician's discretion.
Intervention code [1] 3978 0
Treatment: Drugs
Comparator / control treatment
Identical placebo (sugar pills) made by the same manufacturer once daily for 4 - 6 weeks will be administered to all patients in the control group according to the clinician's discretion.
Control group
Placebo

Outcomes
Primary outcome [1] 5358 0
Decrease in hyperresponsiveness in methacoline challenge test at Baseline and at 4-6 weeks
Timepoint [1] 5358 0
at Baseline and at 4-6 weeks from the start of the treatment
Secondary outcome [1] 9008 0
Decrease in cough (questionnaire) at Baseline and at 4-6 weeks from the start of the treatment
Timepoint [1] 9008 0
at Baseline and at 4-6 weeks from the start of the treatment
Secondary outcome [2] 241624 0
serum IgE (lab test) at Baseline and at 4-6 weeks from the start of the treatment.
Timepoint [2] 241624 0
at Baseline and at 4-6 weeks from the start of the treatment
Secondary outcome [3] 241625 0
blood eosinophilia (lab test) at Baseline and at 4-6 weeks from the start of the treatment
Timepoint [3] 241625 0
at Baseline and at 4-6 weeks from the start of the treatment

Eligibility
Key inclusion criteria
Patients present with cough for more than 6 weeks.
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who had contraindication for methacoline challenge test (according to American Thoracic Society/European Respiratory Society -ATS/ERS- guideline 2006)/ patient with previous diagnosis of asthma/patients who suffer heart failure/ obvious paroxysmal nocturnal dyspnea (PND) or wheezing in physical exam.

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)
The treatment allocation was randomized by a researcher who is not directly involved in the trial. Central randomization by telephone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 1552 0
Iran, Islamic Republic Of
State/province [1] 1552 0

Funding & Sponsors
Funding source category [1] 4435 0
Other
Name [1] 4435 0
National Research Institute for Tuberculosis and Lung Diseases (NRITLD)
Country [1] 4435 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Shahid Beheshti University, M.C.
Address
Evin Ave., Tehran, 19834
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 3996 0
None
Name [1] 3996 0
Address [1] 3996 0
Country [1] 3996 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6487 0
Masih Daneshvari Research Ethics Committee
Ethics committee address [1] 6487 0
Ethics committee country [1] 6487 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 6487 0
Approval date [1] 6487 0
01/09/2008
Ethics approval number [1] 6487 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29236 0
Address 29236 0
Country 29236 0
Phone 29236 0
Fax 29236 0
Email 29236 0
Contact person for public queries
Name 12483 0
Fanak Fahimi, Majid malekmohammad
Address 12483 0
Shaheed Bahonar Ave, Darabad, TEHRAN 19569,P.O: 19575/154
Country 12483 0
Iran, Islamic Republic Of
Phone 12483 0
+98 21 20109503
Fax 12483 0
+98 21 20109503
Email 12483 0
[email protected] [email protected] [email protected]
Contact person for scientific queries
Name 3411 0
Professor Mohammad Reza Masjedi
Address 3411 0
Shaheed Bahonar Ave, Darabad, TEHRAN 19569,P.O: 19575/154
Country 3411 0
Iran, Islamic Republic Of
Phone 3411 0
+98 21 20109991
Fax 3411 0
+98 21 20109503
Email 3411 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.