ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Perennial and Preseasonal Subcutaneous Immunotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01555736
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : March 21, 2012
Sponsor:
Collaborator:
Allergopharma GmbH & Co. KG
Information provided by (Responsible Party):
Piotr Kuna, MD, PhD, Medical Universtity of Lodz

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : January 2003
Actual Primary Completion Date : July 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever
Drug Information available for: Bee pollen
U.S. FDA Resources

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 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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: March 21, 2012
Last Verified: March 2012

Keywords provided by Piotr Kuna, MD, PhD, Medical Universtity of Lodz:
allergic rhinitis
perennial immunotherapy
preseasonal immunotherapy

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