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Comparison of Perennial and Preseasonal Subcutaneous Immunotherapy

Primary Purpose

Seasonal Allergic Rhinitis

Status

Completed

Phase

Phase 4

Locations

Poland

Study Type

Interventional

Intervention

grass (80%) and rye (20%) pollens allergoids

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring allergic rhinitis, perennial immunotherapy, preseasonal immunotherapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Department of Internal diseases, Asthma and Allergy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

preseasonal immunotherapy scheme

perennial immunotherapy scheme

Arm Description

Outcomes

Primary Outcome Measures

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

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

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

Secondary Outcome Measures

frequency of adverse reactions during immunotherapy

type of adverse reactions

the differences from baseline in mean daily rhinoconjunctivitis symptoms score

the differences between study groups in mean daily rhinoconjunctivitis symptoms score

the differences from baseline in combined symptom medication score

the differences from baseline a in serum level of sIgG4

the differences between study groups in combined symptom medication score

the differences between study groups in serum level of sIgG4

Full Information

NCT ID

NCT01555736

First Posted

March 6, 2012

Last Updated

March 19, 2012

Sponsor

Medical University of Lodz

Collaborators

Allergopharma GmbH & Co. KG

1. Study Identification

Unique Protocol Identification Number

NCT01555736

Brief Title

Comparison of Perennial and Preseasonal Subcutaneous Immunotherapy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

July 2006 (Actual)

Study Completion Date

September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Lodz

Collaborators

Allergopharma GmbH & Co. KG

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Seasonal Allergic Rhinitis

Keywords

allergic rhinitis, perennial immunotherapy, preseasonal immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

preseasonal immunotherapy scheme

Arm Type

Active Comparator

Arm Title

perennial immunotherapy scheme

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

grass (80%) and rye (20%) pollens allergoids

Other Intervention Name(s)

Allergovit

Intervention Description

comparison of two schemes of immunotherapy - preseasonal and perennial immunotherapy.

Primary Outcome Measure Information:

Title

difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 1st year of immunotherapy

Description

combined symptom medication score was calculated as a sum of rhinoconjunctivitis symptoms and use of rescue medications during pollen season

Time Frame

up to 3 months

Title

difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 2nd year of immunotherapy

Description

combined symptom medication score was calculated as a sum of rhinoconjunctivitis symptoms and use of rescue medications during pollen season

Time Frame

up to 3 months

Title

difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 3rd year of immunotherapy

Description

combined symptom medication score was calculated as a sum of rhinoconjunctivitis symptoms and use of rescue medications during pollen season

Time Frame

up to 3 months

Secondary Outcome Measure Information:

Title

frequency of adverse reactions during immunotherapy

Time Frame

up to 3 years of immunotherapy

Title

type of adverse reactions

Time Frame

up to 3 years of immunotherapy

Title

the differences from baseline in mean daily rhinoconjunctivitis symptoms score

Time Frame

up to 3 months/4 years

Title

the differences between study groups in mean daily rhinoconjunctivitis symptoms score

Time Frame

up to 3 months/4 years

Title

the differences from baseline in combined symptom medication score

Time Frame

up to 3 months/4 years

Title

the differences from baseline a in serum level of sIgG4

Time Frame

the peak of each pollen season (June) during 4 years of study

Title

the differences between study groups in combined symptom medication score

Time Frame

up to 3 months/4 years

Title

the differences between study groups in serum level of sIgG4

Time Frame

up to 3 months/4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Piotr Kuna, MD, PhD

Organizational Affiliation

Department of Internal Diseases, Asthma and allergy, Medical University of Lodz

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Internal diseases, Asthma and Allergy

City

Lodz

ZIP/Postal Code

90-153

Country

Poland

12. IPD Sharing Statement

Citations:

PubMed Identifier

23636036

Citation

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.

Results Reference

derived

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Comparison of Perennial and Preseasonal Subcutaneous Immunotherapy

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