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Comparison of Perennial and Preseasonal Subcutaneous Immunotherapy

This study has been completed.
Sponsor:
Collaborator:
Allergopharma GmbH & Co. KG
Information provided by (Responsible Party):
Piotr Kuna, MD, PhD, Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT01555736
First received: March 6, 2012
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: grass (80%) and rye (20%) pollens allergoids
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Medical Universtity of Lodz:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 3 years of immunotherapy ] [ Designated as safety issue: Yes ]
  • type of adverse reactions [ Time Frame: up to 3 years of immunotherapy ] [ Designated as safety issue: Yes ]
  • the differences from baseline in mean daily rhinoconjunctivitis symptoms score [ Time Frame: up to 3 months/4 years ] [ Designated as safety issue: No ]
  • the differences between study groups in mean daily rhinoconjunctivitis symptoms score [ Time Frame: up to 3 months/4 years ] [ Designated as safety issue: No ]
  • the differences from baseline in combined symptom medication score [ Time Frame: up to 3 months/4 years ] [ Designated as safety issue: No ]
  • the differences from baseline a in serum level of sIgG4 [ Time Frame: the peak of each pollen season (June) during 4 years of study ] [ Designated as safety issue: No ]
  • the differences between study groups in combined symptom medication score [ Time Frame: up to 3 months/4 years ] [ Designated as safety issue: No ]
  • the differences between study groups in serum level of sIgG4 [ Time Frame: up to 3 months/4 years ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: January 2003
Study Completion Date: September 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: preseasonal immunotherapy scheme Drug: grass (80%) and rye (20%) pollens allergoids
comparison of two schemes of immunotherapy - preseasonal and perennial immunotherapy.
Other Name: 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 Name: Allergovit

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555736

Locations
Poland
Department of Internal diseases, Asthma and Allergy
Lodz, Poland, 90-153
Sponsors and Collaborators
Medical Universtity of Lodz
Allergopharma GmbH & Co. KG
Investigators
Principal Investigator: Piotr Kuna, MD, PhD Department of Internal Diseases, Asthma and allergy, Medical University of Lodz
  More Information

No publications provided by Medical Universtity of Lodz

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Piotr Kuna, MD, PhD, Professor, Medical Universtity of Lodz
ClinicalTrials.gov Identifier: NCT01555736     History of Changes
Other Study ID Numbers: Ne0103AV
Study First Received: March 6, 2012
Last Updated: March 19, 2012
Health Authority: Poland: Ethics Committee

Keywords provided by Medical Universtity of Lodz:
allergic rhinitis
perennial immunotherapy
preseasonal immunotherapy

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 25, 2014