Comparison of Perennial and Preseasonal Subcutaneous Immunotherapy
A Randomised Double-blind Clinical Trial for Evaluation of Efficacy and Safety of Perennial in Comparison to Preseasonal Grass/Rye Pollen Immunotherapy in Patients Suffering From Seasonal Allergic Rhinitis
1 other identifier
interventional
120
1 country
1
Brief Summary
Specific immunotherapy, which involves the administration of allergic extracts to patients with symptoms of allergic disorder, is the leading therapeutical tool of modern allergology. According to the latest studies immunotherapy not only reduces symptoms' severity but also may modify the course of allergic disease by reducing the risk of new sensitisations and development of more advanced stages of the disease.It has been hypothesized basing on clinical observation that perennial immunotherapy is more effective and safer in comparison to preseasonal immunotherapy. The aim of the study was to compare the effect of perennial and preseasonal immunotherapy on rhinoconjunctivitis symptoms and safety of both treatments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2003
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 6, 2012
CompletedFirst Posted
Study publicly available on registry
March 15, 2012
CompletedMarch 21, 2012
March 1, 2012
3.5 years
March 6, 2012
March 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 1st year of immunotherapy
combined symptom medication score was calculated as a sum of rhinoconjunctivitis symptoms and use of rescue medications during pollen season
up to 3 months
difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 2nd year of immunotherapy
combined symptom medication score was calculated as a sum of rhinoconjunctivitis symptoms and use of rescue medications during pollen season
up to 3 months
difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 3rd year of immunotherapy
combined symptom medication score was calculated as a sum of rhinoconjunctivitis symptoms and use of rescue medications during pollen season
up to 3 months
Secondary Outcomes (8)
frequency of adverse reactions during immunotherapy
up to 3 years of immunotherapy
type of adverse reactions
up to 3 years of immunotherapy
the differences from baseline in mean daily rhinoconjunctivitis symptoms score
up to 3 months/4 years
the differences between study groups in mean daily rhinoconjunctivitis symptoms score
up to 3 months/4 years
the differences from baseline in combined symptom medication score
up to 3 months/4 years
- +3 more secondary outcomes
Study Arms (2)
preseasonal immunotherapy scheme
ACTIVE COMPARATORperennial immunotherapy scheme
ACTIVE COMPARATORInterventions
comparison of two schemes of immunotherapy - preseasonal and perennial immunotherapy.
Eligibility Criteria
You may qualify if:
- IgE-mediated seasonal allergic rhinitis with symptoms during the grass and rye pollens season (May, June, July);
- Symptoms of allergic rhinoconjunctivitis requiring medication during the last season
- Positive skin prick test to grass and rye pollens only with wheal at least as large as histamine control reaction and diameter \> 5mm;
- For female patients effective contraception and negative pregnancy test results were necessary.
You may not qualify if:
- Previous course of immunotherapy with grass and rye pollens extracts or allergens which are unknown during the last 5 years
- FEV1 \< 80% of predicted
- Uncontrolled bronchial asthma according to GINA
- Non-allergic rhinoconjunctivitis
- Severe acute or chronic diseases, severe inflammatory diseases
- Autoimmune diseases, immunosuppression, neoplastic diseases
- Severe psychiatric and psychological disorders including alcohol or drug abuse
- Contraindication for application of adrenaline;
- Treatment with beta-blockers
- Pregnancy or lactation period
- Females patients seeking to become pregnant
- Low compliance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of Lodzlead
- Allergopharma GmbH & Co. KGcollaborator
Study Sites (1)
Department of Internal diseases, Asthma and Allergy
Lodz, 90-153, Poland
Related Publications (1)
Tworek D, Bochenska-Marciniak M, Kuprys-Lipinska I, Kupczyk M, Kuna P. Perennial is more effective than preseasonal subcutaneous immunotherapy in the treatment of seasonal allergic rhinoconjunctivitis. Am J Rhinol Allergy. 2013 Jul-Aug;27(4):304-8. doi: 10.2500/ajra.2013.27.3935. Epub 2013 Apr 29.
PMID: 23636036DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Piotr Kuna, MD, PhD
Department of Internal Diseases, Asthma and allergy, Medical University of Lodz
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 6, 2012
First Posted
March 15, 2012
Study Start
January 1, 2003
Primary Completion
July 1, 2006
Study Completion
September 1, 2006
Last Updated
March 21, 2012
Record last verified: 2012-03