Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000555853
Ethics application status
Approved
Date submitted
21/05/2012
Date registered
25/05/2012
Date last updated
31/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Outcome of allergen specific immunotherapy in asthmatic children
Scientific title
Long-term clinical and immunological effect of sublingual and subcutaneous immunotherapy in dust mite allergic asthma/rhinitis children: 3 years prospective randomized controlled trial
Secondary ID [1] 280544 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
childhood atopic asthma 286506 0
rhinitis 286507 0
Condition category
Condition code
Respiratory 286767 286767 0 0
Asthma
Inflammatory and Immune System 286810 286810 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. sublingual immunotherapy (SLIT)+standard pharmacotherapy (SP)
patients receive SLIT as 5 sublingual droplets three times a week for 3 years (Dermatophagoides pteronyssinus and pharinea %50 mix) after following an induction phase for 1 month of slowly increasing dosing schedule reaching the maintenance dose mentioned above with the same preparation
1st dose is supervised by the physician and the rest is ingested by patient at home

2. subcutaneous immunotherapy (SCIT)+standard pharmacotherapy
SCIT is received by subcutaneous injection at the hospital by the physician once a month for 3 years (Dermatophagoides pteronyssinus and pharinea %50 mix) following a weekly injection (for 3 months) of increasing doses of allergen.
a)starting dose of SCIT 0.1 ml of 100u/ml b) maintenance dose of SCIT 1 ml of 100000u/ml of allegen injected
every child is supervised by a physician following the injection for half an hour
Intervention code [1] 284893 0
Treatment: Drugs
Comparator / control treatment
standard pharmacotherapy

inhaled fluticasone is administered (125 mcg) twice a day by aerospacer and puffs. Dose adjustment is made by symptom severity and disease control
Control group
Active

Outcomes
Primary outcome [1] 287153 0
clinical improvement by symptom severity and medication need, asthma attacks/year, pulmonary function tests, Der p 1 specific IgE levels, bronchial reactivity
Timepoint [1] 287153 0
baseline, 1st year, 3rd year
Secondary outcome [1] 297508 0
immunological dynamics
peripheral blood mononuclear cells cultured wit Der P 1 (recombinant house dust mite allergen) and supernatants assayed for IL-4, 5, 13, 10, 17, TGF-b and IFN-g sscretion
Timepoint [1] 297508 0
baseline, 1st year, 3rd year

Eligibility
Key inclusion criteria
to have informed consent
house dust mite sensitized
asthmatic/rhinitis child
Minimum age
5 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
previous immunotherapy
chronic disease
malignancy
uncontrolled asthma

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 4325 0
Turkey
State/province [1] 4325 0
Istanbul

Funding & Sponsors
Funding source category [1] 285289 0
University
Name [1] 285289 0
Marmara University BAPKO
Country [1] 285289 0
Turkey
Primary sponsor type
University
Name
Marmara University BAPKO
Address
Marmara Universitesi Rektorluk Binasi
BAPKO 34722
Goztepe Istanbul
Country
Turkey
Secondary sponsor category [1] 284148 0
None
Name [1] 284148 0
Address [1] 284148 0
Country [1] 284148 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287331 0
Marmara University Ethical Comittee
Ethics committee address [1] 287331 0
Marmara Universitesi
Tip Fakultesi Deontoloji BD
Haydarpasa 34668
Ethics committee country [1] 287331 0
Turkey
Date submitted for ethics approval [1] 287331 0
16/01/2007
Approval date [1] 287331 0
28/02/2007
Ethics approval number [1] 287331 0
30.02.FEB.0.01.02/AEK/988
Ethics committee name [2] 287350 0
NewMarmara University Ethical Comittee
Ethics committee address [2] 287350 0
Marmara Universitesi Tip Fakultesi Deontoloji BD Haydarpasa 34668
Ethics committee country [2] 287350 0
Turkey
Date submitted for ethics approval [2] 287350 0
12/03/2010
Approval date [2] 287350 0
28/09/2010
Ethics approval number [2] 287350 0
B.30.2.MAR.0.01.02/AEK/707

Summary
Brief summary
randomized controlled open trial of children with mild persistant asthma, HDM sensitized were included. All evaluated at baseline 1st and 3rd years with clinical status, bronchial hyperreactivity and immunological parameters
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34200 0
Address 34200 0
Country 34200 0
Phone 34200 0
Fax 34200 0
Email 34200 0
Contact person for public queries
Name 17447 0
Elif Aydiner
Address 17447 0
Marmara University Pendik EAH
Fevzi cakmak Mh Pendik Istanbul 34890
Country 17447 0
Turkey
Phone 17447 0
+905323517683
Fax 17447 0
Email 17447 0
[email protected]
Contact person for scientific queries
Name 8375 0
Elif Aydiner
Address 8375 0
Marmara University Pendik EAH
Fevzi cakmak Mh Pendik Istanbul 34890
Country 8375 0
Turkey
Phone 8375 0
+905323517683
Fax 8375 0
Email 8375 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.