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Trial registered on ANZCTR
Registration number
ACTRN12613000484741
Ethics application status
Approved
Date submitted
14/04/2013
Date registered
1/05/2013
Date last updated
6/05/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
The clinical and immunological effects of short-term preseasonal grass pollen immunotherapy in patients with allergic rhinitis sensitized to grass pollens
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Scientific title
Short-term preseasonal grass pollen allergoid immunotherapy in patients with allergic rhinitis sensitized to grass pollens: Clinical and immunological effects
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Secondary ID [1]
282334
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Nil
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Universal Trial Number (UTN)
Nil
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Allergic Rhinitis
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Condition category
Condition code
Inflammatory and Immune System
289224
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0
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Allergies
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Subjects were randomized to receive active preseasonal short-term grass pollen allergoid immunotherapy or placebo using a double-blind method. The immunotherapy product was a preparation of extracts of six-grass pollens treated with formaldehyde to produce an allergoid and adsorbed onto aluminium hydroxide. It was supplied in two concentrations, 1000 therapeutic units (TU)/ml and 10000 TU/ml. Subcutaneous injections commenced before the onset of the pollen season with 0.1 ml of 1000 TU/ml in February 2010 and followed by an approximate doubling of the dose weekly up to 0.6 ml of 10000 TU/ml. The standard regimen comprised of seven injections, once weekly, for seven weeks. Dose adjustments were made according to individual tolerance. The highest grass pollen grains are recorded between April and August in Turkey. Due to different times of pollination of the members of the Gramineae family, Gramineae pollens are usually found in the air during the whole year except a few months in Turkey. We used 01 March - 01 September as the pollen period in this trial and followed up participants for six months after the administration of the last injection.
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Intervention code [1]
286949
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Treatment: Drugs
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Comparator / control treatment
Placebo was used as the control treatment. Placebo solution contained physiological saline. Subcutaneous injections commenced with 0.1 ml in February 2010 and followed by an approximate doubling of the dose weekly up to 0.6 ml. The standard regimen comprised of seven injections. Dose adjustments were made according to individual tolerance.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Average combined (symptom and medication) score during the grass pollen season using symptom and medication diaries. All patients recorded their symptoms and medications daily during the pollen season in 2010. Nasal symptoms (itching, sneezing, discharge, obstruction) and ocular symptoms (itching, watery eyes) were recorded on a scale of 4. The average rhinoconjunctivitis total symptom score was calculated as the mean of the daily total symptom score. Patients were instructed to use a stepwise regimen for rescue medication (step-1 oral desloratadine 5 mg, step-2 fluticasone furoate nasal spray, step-3 oral metilprednisolone 4 mg). Medication scores were as follows: 0=no medication; 1=desloratadine; 2=nasal fluticasone furoate; 3=oral metilprednisolone taken. Average combined score was calculated as the mean of average rhinoconjunctivitis total symptom score and medication score.
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Assessment method [1]
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Timepoint [1]
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Monitored on a daily basis for 6 months during the pollen period after intervention (1-7 months after intervention commencement)
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Primary outcome [2]
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Allergen induced basophil activation assessed by measurement of CD203c expression
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Assessment method [2]
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Timepoint [2]
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Pre-intervention (immediately before the first intervention visit) and post-intervention (immediately after the last intervention visit) and at the peak pollen season after intervention (3 months after intervention commencement)
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Primary outcome [3]
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Frequency of CD4+CD25high forkhead box P3+ (FoxP3) regulatory T cells analyzed in peripheral blood using a three-color staining method by Flow Cytometer
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Assessment method [3]
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Timepoint [3]
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Pre-intervention (immediately before the first intervention visit) and post-intervention (immediately after the last intervention visit) and at the peak pollen season after intervention (3 months after intervention commencement)
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Secondary outcome [1]
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Average rhinoconjunctivitis total symptom score during the grass pollen season using symptom diaries. Nasal symptoms (itching, sneezing, discharge, obstruction) and ocular symptoms (itching, watery eyes) were recorded on a scale of 4. The average rhinoconjunctivitis total symptom score was calculated as the mean of the daily total symptom score.
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Assessment method [1]
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Timepoint [1]
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Monitored on a daily basis for 6 months during the pollen period after intervention (1-7 months after intervention commencement)
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Secondary outcome [2]
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Medication score during the grass pollen season using medication diaries. Patients were instructed to use a stepwise regimen for rescue medication (step-1 oral desloratadine 5 mg, step-2 fluticasone furoate nasal spray, step-3 oral metilprednisolone 4 mg). Medication scores were as follows: 0=no medication; 1=desloratadine; 2=nasal fluticasone furoate; 3=oral metilprednisolone taken.
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Assessment method [2]
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Timepoint [2]
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Monitored on a daily basis for 6 months during the pollen period after intervention (1-7 months after intervention commencement)
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Secondary outcome [3]
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Severity of allergic symptoms for each month during the pollen period on a visual analogue scale
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Assessment method [3]
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Timepoint [3]
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Monitored on a monthlty basis for 6 months during the pollen period after intervention (1-7 months after intervention commencement)
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Secondary outcome [4]
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Quality of life, assessed by using Turkish version of the Juniper rhinoconjunctivitis quality-of-life questionnaire
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Assessment method [4]
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Timepoint [4]
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At the peak pollen period before end after intervention and at the end of pollen period before and after intervention
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Secondary outcome [5]
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Levels of Phleum pratense-specific Immunoglobulin G4 using CAP fluoroenzyme immunoassay system
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Assessment method [5]
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Timepoint [5]
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Pre-intervention (immediately before the first intervention visit) and post-intervention (immediately after the last intervention visit) and at the peak pollen season after intervention (3 months after intervention commencement)
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Secondary outcome [6]
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Levels of Phleum pratense-specific Immunoglobulin E using CAP fluoroenzyme immunoassay system
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Assessment method [6]
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Timepoint [6]
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Pre-intervention (immediately before the first intervention visit) and post-intervention (immediately after the last intervention visit) and at the peak pollen season after intervention (3 months after intervention commencement)
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Eligibility
Key inclusion criteria
History of seasonal allergic rhinitis caused by grass pollens, positive skin prick test result (wheal diameter =3 mm) to grass pollen extract, no inhalant allergen sensitization other than pollens
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Minimum age
17
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Presence of asthma, previous allergen immunotherapy, inhalant allergen sensitization other than pollens, pregnant women, presence of severe systemic disease
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
Comparisons between groups were performed using the Student’s t-test or the Mann-Whitney test where applicable. Group-time comparisons were performed using a macro developed for F1-LD-F1 design. Anova-type statistics were used to evaluate the significancy of the factors. Pair-wise comparisons within the groups were performed by Wilcoxon signed-rank test. The sample size was estimated according to the number of eligible patients in the relevant time period.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/05/2009
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Actual
25/05/2009
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Date of last participant enrolment
Anticipated
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Actual
29/05/2009
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
31
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
5018
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Turkey
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State/province [1]
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Ankara
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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The Scientific and Technological Research Council of Turkey
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Address [1]
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TUBITAK Baskanlik, Tunus Caddesi No:80
06100 Kavaklidere, Ankara, Turkiye
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Country [1]
287091
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Turkey
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Funding source category [2]
287092
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University
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Name [2]
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The Scientific Research Projects Office of Ankara University
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Address [2]
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Ankara Universitesi Bilimsel Arastirma Projeleri Ofisi, Dogol Caddesi 06100 Tandogan, Ankara, Turkiye
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Country [2]
287092
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Turkey
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Funding source category [3]
287093
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Commercial sector/Industry
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Name [3]
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Allergopharma
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Address [3]
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Allergopharma GmbH & Co. KG Hermann-Korner-Strasse 52 21465 Reinbek, Deutschland/Germany
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Country [3]
287093
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Germany
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Primary sponsor type
Individual
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Name
Zeynep Misirligil
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Address
Ankara Universitesi Tip Fakultesi, Tip Fakultesi Caddesi, Gogus Hastaliklari ABD, Allerji ve Immunoloji BD, 06100, Cebeci, Ankara, Turkiye
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Country
Turkey
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Secondary sponsor category [1]
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Individual
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Name [1]
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Betul Ayse Sin
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Address [1]
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Ankara Universitesi Tip Fakultesi, Tip Fakultesi Caddesi, Gogus Hastaliklari ABD, Allerji ve Immunoloji BD, 06100, Cebeci, Ankara, Turkiye
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Country [1]
285867
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Turkey
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Secondary sponsor category [2]
285868
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Individual
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Name [2]
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Aydan Ikinciogullari
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Address [2]
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Ankara Universitesi Tip Fakultesi, Tip Fakultesi Caddesi, Cocuk Sagligi ve Hastaliklari ABD, Pediatrik Allerji ve Immunoloji BD, 06100, Cebeci, Ankara, Turkiye
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Country [2]
285868
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Turkey
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Secondary sponsor category [3]
285869
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Individual
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Name [3]
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Secil Kepil Ozdemir
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Address [3]
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Ankara Universitesi Tip Fakultesi, Tip Fakultesi Caddesi, Gogus Hastaliklari ABD, Allerji ve Immunoloji BD, 06100, Cebeci, Ankara, Turkiye
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Country [3]
285869
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Turkey
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Secondary sponsor category [4]
285870
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Individual
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Name [4]
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Deniz Guloglu
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Address [4]
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Ankara Universitesi Tip Fakultesi, Tip Fakultesi Caddesi, Cocuk Sagligi ve Hastaliklari ABD, Pediatrik Allerji ve Immunoloji BD, 06100, Cebeci, Ankara, Turkiye
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Country [4]
285870
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Turkey
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289107
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Research Ethics Committee of Medical Faculty, Ankara University
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Ethics committee address [1]
289107
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Ankara Universitesi Tip Fakultesi Etik Kurulu, Ankara Universitesi Tip Fakultesi Morfoloji Yerleskesi, 06100, Sihhiye, Ankara, Turkiye
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Ethics committee country [1]
289107
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Turkey
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Date submitted for ethics approval [1]
289107
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Approval date [1]
289107
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25/05/2009
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Ethics approval number [1]
289107
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Summary
Brief summary
The present randomized, double-blind, placebo-controlled study aimed to investigate the immunological and clinical effects of short-term preseasonal grass pollen allergoid immunotherapy in allergic rhinitis.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Zeynep Misirligil
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Address
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Ankara Universitesi Tip Fakultesi, Tip Fakultesi Caddesi, Gogus Hastaliklari ABD, Allerji ve Immunoloji BD, 06100, Cebeci, Ankara, Turkiye
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Country
39274
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Turkey
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Phone
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+90 312 5956559
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Fax
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Email
39274
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[email protected]
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Contact person for public queries
Name
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Dr Secil Kepil Ozdemir
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Address
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Ankara Universitesi Tip Fakultesi, Tip Fakultesi Caddesi, Gogus Hastaliklari ABD, Allerji ve Immunoloji BD, 06100, Cebeci, Ankara, Turkiye
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Country
39275
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Turkey
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Phone
39275
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+90 312 5956584
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Fax
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Email
39275
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[email protected]
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Contact person for scientific queries
Name
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Dr Secil Kepil Ozdemir
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Address
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Ankara Universitesi Tip Fakultesi, Tip Fakultesi Caddesi, Gogus Hastaliklari ABD, Allerji ve Immunoloji BD, 06100, Cebeci, Ankara, Turkiye
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Country
39276
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Turkey
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Phone
39276
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+90 312 5956584
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Fax
39276
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Email
39276
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[email protected]
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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.
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