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

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.

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: grass (80%) and rye (20%) pollens allergoids

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Lodz, Poland, 90-153
    • Department of Internal diseases, Asthma and Allergy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. IgE-mediated seasonal allergic rhinitis with symptoms during the grass and rye pollens season (May, June, July);
2. Symptoms of allergic rhinoconjunctivitis requiring medication during the last season
3. Positive skin prick test to grass and rye pollens only with wheal at least as large as histamine control reaction and diameter > 5mm;
4. For female patients effective contraception and negative pregnancy test results were necessary.

Exclusion Criteria:

1. Previous course of immunotherapy with grass and rye pollens extracts or allergens which are unknown during the last 5 years
2. FEV1 < 80% of predicted
3. Uncontrolled bronchial asthma according to GINA
4. Non-allergic rhinoconjunctivitis
5. Severe acute or chronic diseases, severe inflammatory diseases
6. Autoimmune diseases, immunosuppression, neoplastic diseases
7. Severe psychiatric and psychological disorders including alcohol or drug abuse
8. Contraindication for application of adrenaline;
9. Treatment with beta-blockers
10. Pregnancy or lactation period
11. Females patients seeking to become pregnant
12. Low compliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: preseasonal immunotherapy scheme	Drug: grass (80%) and rye (20%) pollens allergoids; comparison of two schemes of immunotherapy - preseasonal and perennial immunotherapy.; Other Names: Allergovit
Active Comparator: perennial immunotherapy scheme	Drug: grass (80%) and rye (20%) pollens allergoids; comparison of two schemes of immunotherapy - preseasonal and perennial immunotherapy.; Other Names: Allergovit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
the differences from baseline a in serum level of sIgG4	the peak of each pollen season (June) during 4 years of study
the differences between study groups in combined symptom medication score	up to 3 months/4 years
the differences between study groups in serum level of sIgG4	up to 3 months/4 years

Collaborators and Investigators

• Sponsor: Medical University of Lodz
• Collaborators: Allergopharma GmbH & Co. KG
• Investigators: Principal Investigator: Piotr Kuna, MD, PhD, Department of Internal Diseases, Asthma and allergy, Medical University of Lodz

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): September 1, 2006

Study Registration Dates

• First Submitted: March 6, 2012
• First Submitted That Met QC Criteria: March 14, 2012
• First Posted (Estimate): March 15, 2012

Study Record Updates

• Last Update Posted (Estimate): March 21, 2012
• Last Update Submitted That Met QC Criteria: March 19, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: allergic rhinitis; perennial immunotherapy; preseasonal immunotherapy
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: Ne0103AV