Comparison of Perennial and Preseasonal Subcutaneous Immunotherapy

Seasonal Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01555736
• Other study ID #: Ne0103AV
• Status: Completed
• Phase: Phase 4
• First received: March 6, 2012
• Last updated: March 19, 2012
• Start date: January 2003
• Est. completion date: September 2006

Study information

• Verified date: March 2012
• Source: Medical Universtity of Lodz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• grass (80%) and rye (20%) pollens allergoids
comparison of two schemes of immunotherapy - preseasonal and perennial immunotherapy.

Locations

Country	Name	City	State
Poland	Department of Internal diseases, Asthma and Allergy	Lodz

Sponsors (2)

Lead Sponsor	Collaborator
Medical Universtity of Lodz	Allergopharma GmbH & Co. KG

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	frequency of adverse reactions during immunotherapy		up to 3 years of immunotherapy	Yes
Secondary	type of adverse reactions		up to 3 years of immunotherapy	Yes
Secondary	the differences from baseline in mean daily rhinoconjunctivitis symptoms score		up to 3 months/4 years	No
Secondary	the differences between study groups in mean daily rhinoconjunctivitis symptoms score		up to 3 months/4 years	No
Secondary	the differences from baseline in combined symptom medication score		up to 3 months/4 years	No
Secondary	the differences from baseline a in serum level of sIgG4		the peak of each pollen season (June) during 4 years of study	No
Secondary	the differences between study groups in combined symptom medication score		up to 3 months/4 years	No
Secondary	the differences between study groups in serum level of sIgG4		up to 3 months/4 years	No