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Trial registered on ANZCTR


Registration number
ACTRN12613000315718
Ethics application status
Approved
Date submitted
13/03/2013
Date registered
20/03/2013
Date last updated
20/03/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of dust mite sublingual immunotherapy in children with allergic rhinitis.
Scientific title
Sublingual immunotherapy in children with allergic rhinoconjunctivitis mono-sensitized to house dust mites: A Double-Blind-Placebo-Controlled Randomised Trial
Secondary ID [1] 282112 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic Rhinitis 288555 0
Allergic conjunctivitis 288556 0
Bronchial hyper-responsiveness 288557 0
Condition category
Condition code
Inflammatory and Immune System 288885 288885 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects were randomized to receive active sublingual immunotherapy or placebo using a double-blind method. Active Sublingual immunotherapy containing 300 Index of Reactivity/mL of Dermatophagoides pteronyssinus and Dermatophagoides farinae 50:50% or placebo. Both active sublingual immunotherapy and placebo were administered sublingually with 8 drops/once a day 3 times a week, for a 12 months treatment duration.
Intervention code [1] 286667 0
Treatment: Drugs
Comparator / control treatment
Placebo group act as a control. Placebo contained solution as in the active immunotherapy without active allergen extract (Dermatophagoides pteronyssinus and Dermatophagoides farinae 50:50%). Given as sublingual drops.
Control group
Placebo

Outcomes
Primary outcome [1] 289017 0
Total rhinitis symproms scores. Using symptoms scores questionnaire evaluating sneezing, itchy, rhinorhea and blockage according to its severity. None=0, mild=1, moderate=2 and severe=3.
Timepoint [1] 289017 0
12 months after randomisation
Primary outcome [2] 289081 0
Conjunctivitis symptom scores. Using symptom scores questionnaire evaluating, eye redness, itchy and watery.
Timepoint [2] 289081 0
12 months after randomisation
Primary outcome [3] 289082 0
Medication scores. Using medication scores questionnaire.
Timepoint [3] 289082 0
12 months after randomisation
Secondary outcome [1] 301573 0
Pulmonary function tests. Using spirometry to assess lung function.
Timepoint [1] 301573 0
12 months after randomisation
Secondary outcome [2] 301711 0
Allergen specific nasal provocation test. Using house dust mite allergen extract, patients were provoked producing rhinitis symptoms.
Timepoint [2] 301711 0
12 months after randomisation
Secondary outcome [3] 301712 0
Bronchial reactivity. Using methacholine provocation test.
Timepoint [3] 301712 0
12 months after randomisation

Eligibility
Key inclusion criteria
Children aged between 5-10 years of both genders with the history of persistent allergic rhinitis without asthmatic symptoms.
Minimum age
5 Years
Maximum age
10 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergic asthma, previous allergen immunotherapy, chronic disease, malignancy.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4898 0
Turkey
State/province [1] 4898 0

Funding & Sponsors
Funding source category [1] 286843 0
University
Name [1] 286843 0
Marmara University medical faculty
Address [1] 286843 0
Marmara Universitesi Rektorluk Binasi BAPKO 34722 Goztepe Istanbul
Country [1] 286843 0
Turkey
Primary sponsor type
University
Name
Marmara University medical faculty
Address
Marmara Universitesi Rektorluk Binasi BAPKO 34722 Goztepe Istanbul
Country
Turkey
Secondary sponsor category [1] 285632 0
None
Name [1] 285632 0
Address [1] 285632 0
Country [1] 285632 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288908 0
Marmara University Ethical Comittee
Ethics committee address [1] 288908 0
Marmara Universitesi Tip Fakultesi Deontoloji BD Haydarpasa 34668
Ethics committee country [1] 288908 0
Turkey
Date submitted for ethics approval [1] 288908 0
Approval date [1] 288908 0
Ethics approval number [1] 288908 0

Summary
Brief summary
Double-blind randomized placebo controlled trial of children with persistant rhinitis, allergic to dust mites were included. All evaluationwas done at baseline and 12 months after randomisation as for clinical status, bronchial and nasal hyper-reactivity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38294 0
Dr Metin Aydogan
Address 38294 0
Marmara University Pendik EAH Fevzi cakmak Mh Pendik Istanbul 34890
Country 38294 0
Turkey
Phone 38294 0
+90568963256
Fax 38294 0
Email 38294 0
mmetinaydogan@hotmail.com
Contact person for public queries
Name 38295 0
Dr Metin Aydogan
Address 38295 0
Marmara University Pendik EAH Fevzi cakmak Mh Pendik Istanbul 34890
Country 38295 0
Turkey
Phone 38295 0
+90568963256
Fax 38295 0
Email 38295 0
mmetinaydogan@hotmail.com
Contact person for scientific queries
Name 38296 0
Dr Metin Aydogan
Address 38296 0
Marmara University Pendik EAH Fevzi cakmak Mh Pendik Istanbul 34890
Country 38296 0
Turkey
Phone 38296 0
+90568963256
Fax 38296 0
Email 38296 0
mmetinaydogan@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary