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NCT Number: NCT01555736

Comparison of Perennial and Preseasonal Subcutaneous Immunotherapy

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.

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Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Internal diseases, Asthma and Allergy

Lodz, 90-153, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

Other names: Allergovit

Primary outcomes

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

    Time frame: up to 3 months

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

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

    Time frame: up to 3 months

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

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

    Time frame: up to 3 months

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

Secondary outcomes

  1. frequency of adverse reactions during immunotherapy

    Time frame: up to 3 years of immunotherapy

  2. type of adverse reactions

    Time frame: up to 3 years of immunotherapy

  3. the differences from baseline in mean daily rhinoconjunctivitis symptoms score

    Time frame: up to 3 months/4 years

  4. the differences between study groups in mean daily rhinoconjunctivitis symptoms score

    Time frame: up to 3 months/4 years

  5. the differences from baseline in combined symptom medication score

    Time frame: up to 3 months/4 years

  6. the differences from baseline a in serum level of sIgG4

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

  7. the differences between study groups in combined symptom medication score

    Time frame: up to 3 months/4 years

  8. the differences between study groups in serum level of sIgG4

    Time frame: up to 3 months/4 years

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Collaborators

  • Allergopharma GmbH & Co. KG

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Mar 15, 2012
Registry last updated
Mar 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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