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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
Scientific title
Short-term preseasonal grass pollen allergoid immunotherapy in patients with allergic rhinitis sensitized to grass pollens: Clinical and immunological effects
Secondary ID [1] 282334 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic Rhinitis 288881 0
Condition category
Condition code
Inflammatory and Immune System 289224 289224 0 0
Allergies

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 286949 0
Treatment: Drugs
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.
Control group
Placebo

Outcomes
Primary outcome [1] 289338 0
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.
Timepoint [1] 289338 0
Monitored on a daily basis for 6 months during the pollen period after intervention (1-7 months after intervention commencement)
Primary outcome [2] 289339 0
Allergen induced basophil activation assessed by measurement of CD203c expression
Timepoint [2] 289339 0
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)
Primary outcome [3] 289340 0
Frequency of CD4+CD25high forkhead box P3+ (FoxP3) regulatory T cells analyzed in peripheral blood using a three-color staining method by Flow Cytometer
Timepoint [3] 289340 0
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)
Secondary outcome [1] 302265 0
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.
Timepoint [1] 302265 0
Monitored on a daily basis for 6 months during the pollen period after intervention (1-7 months after intervention commencement)
Secondary outcome [2] 302266 0
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.
Timepoint [2] 302266 0
Monitored on a daily basis for 6 months during the pollen period after intervention (1-7 months after intervention commencement)
Secondary outcome [3] 302267 0
Severity of allergic symptoms for each month during the pollen period on a visual analogue scale
Timepoint [3] 302267 0
Monitored on a monthlty basis for 6 months during the pollen period after intervention (1-7 months after intervention commencement)
Secondary outcome [4] 302268 0
Quality of life, assessed by using Turkish version of the Juniper rhinoconjunctivitis quality-of-life questionnaire
Timepoint [4] 302268 0
At the peak pollen period before end after intervention and at the end of pollen period before and after intervention
Secondary outcome [5] 302269 0
Levels of Phleum pratense-specific Immunoglobulin G4 using CAP fluoroenzyme immunoassay system
Timepoint [5] 302269 0
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)
Secondary outcome [6] 302270 0
Levels of Phleum pratense-specific Immunoglobulin E using CAP fluoroenzyme immunoassay system
Timepoint [6] 302270 0
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)

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
Minimum age
17 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of asthma, previous allergen immunotherapy, inhalant allergen sensitization other than pollens, pregnant women, presence of severe systemic disease

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2009
Actual
25/05/2009
Date of last participant enrolment
Anticipated
Actual
29/05/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
31
Accrual to date
Final
Recruitment outside Australia
Country [1] 5018 0
Turkey
State/province [1] 5018 0
Ankara

Funding & Sponsors
Funding source category [1] 287091 0
Government body
Name [1] 287091 0
The Scientific and Technological Research Council of Turkey
Country [1] 287091 0
Turkey
Funding source category [2] 287092 0
University
Name [2] 287092 0
The Scientific Research Projects Office of Ankara University
Country [2] 287092 0
Turkey
Funding source category [3] 287093 0
Commercial sector/Industry
Name [3] 287093 0
Allergopharma
Country [3] 287093 0
Germany
Primary sponsor type
Individual
Name
Zeynep Misirligil
Address
Ankara Universitesi Tip Fakultesi, Tip Fakultesi Caddesi, Gogus Hastaliklari ABD, Allerji ve Immunoloji BD, 06100, Cebeci, Ankara, Turkiye
Country
Turkey
Secondary sponsor category [1] 285867 0
Individual
Name [1] 285867 0
Betul Ayse Sin
Address [1] 285867 0
Ankara Universitesi Tip Fakultesi, Tip Fakultesi Caddesi, Gogus Hastaliklari ABD, Allerji ve Immunoloji BD, 06100, Cebeci, Ankara, Turkiye
Country [1] 285867 0
Turkey
Secondary sponsor category [2] 285868 0
Individual
Name [2] 285868 0
Aydan Ikinciogullari
Address [2] 285868 0
Ankara Universitesi Tip Fakultesi, Tip Fakultesi Caddesi, Cocuk Sagligi ve Hastaliklari ABD, Pediatrik Allerji ve Immunoloji BD, 06100, Cebeci, Ankara, Turkiye
Country [2] 285868 0
Turkey
Secondary sponsor category [3] 285869 0
Individual
Name [3] 285869 0
Secil Kepil Ozdemir
Address [3] 285869 0
Ankara Universitesi Tip Fakultesi, Tip Fakultesi Caddesi, Gogus Hastaliklari ABD, Allerji ve Immunoloji BD, 06100, Cebeci, Ankara, Turkiye
Country [3] 285869 0
Turkey
Secondary sponsor category [4] 285870 0
Individual
Name [4] 285870 0
Deniz Guloglu
Address [4] 285870 0
Ankara Universitesi Tip Fakultesi, Tip Fakultesi Caddesi, Cocuk Sagligi ve Hastaliklari ABD, Pediatrik Allerji ve Immunoloji BD, 06100, Cebeci, Ankara, Turkiye
Country [4] 285870 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289107 0
Research Ethics Committee of Medical Faculty, Ankara University
Ethics committee address [1] 289107 0
Ethics committee country [1] 289107 0
Turkey
Date submitted for ethics approval [1] 289107 0
Approval date [1] 289107 0
25/05/2009
Ethics approval number [1] 289107 0

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

Contacts
Principal investigator
Name 39274 0
Prof Zeynep Misirligil
Address 39274 0
Ankara Universitesi Tip Fakultesi, Tip Fakultesi Caddesi, Gogus Hastaliklari ABD, Allerji ve Immunoloji BD, 06100, Cebeci, Ankara, Turkiye
Country 39274 0
Turkey
Phone 39274 0
+90 312 5956559
Fax 39274 0
Email 39274 0
zeynep.misirligil@medicine.ankara.edu.tr
Contact person for public queries
Name 39275 0
Secil Kepil Ozdemir
Address 39275 0
Ankara Universitesi Tip Fakultesi, Tip Fakultesi Caddesi, Gogus Hastaliklari ABD, Allerji ve Immunoloji BD, 06100, Cebeci, Ankara, Turkiye
Country 39275 0
Turkey
Phone 39275 0
+90 312 5956584
Fax 39275 0
Email 39275 0
secilkepil@gmail.com
Contact person for scientific queries
Name 39276 0
Secil Kepil Ozdemir
Address 39276 0
Ankara Universitesi Tip Fakultesi, Tip Fakultesi Caddesi, Gogus Hastaliklari ABD, Allerji ve Immunoloji BD, 06100, Cebeci, Ankara, Turkiye
Country 39276 0
Turkey
Phone 39276 0
+90 312 5956584
Fax 39276 0
Email 39276 0
secilkepil@gmail.com

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
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