Birch Pollen Allergy Clinical Trial
Official title:
A Dose-response Evaluation of ALK Tree AIT
The primary aim of this trial is to evaluate the dose-response relationship for the ALK tree AIT administered once daily in order to define a dose-range that would be suitable for at-home administration.
Status | Completed |
Enrollment | 637 |
Est. completion date | September 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years to 65 Years |
Eligibility |
Inclusion Criteria: - A history of moderate to severe birch pollen allergy - Use of symptomatic medication for treatment of birch pollen allergy - Positive skin prick test to birch extract - Positive specific IgE against Bet v 1 Exclusion Criteria: - Overlapping perennial allergies - History of uncontrolled asthma within the last 3 months - FEV1 < 70% of predicted value in adults or FEV1 < 80% of predicted value in adolescents - Previous or ongoing treatment with immunotherapy |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Finland | Skin and Allergy Hospital, Helsinki University Central Hospital | Helsinki | HUS |
Netherlands | Slotervaart Ziekenhuis | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
ALK-Abelló A/S |
Finland, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Allergy symptom severity scores on a scale from 0-3 | Determine the dose-efficacy response relationship of the ALK tree AIT. This information will, in combination with the evaluation of the frequency and severity of adverse events, form the basis of the conclusion on the primary endpoint. | During the birch pollen season 2013, an expected average of 3 weeks | No |
Primary | Adverse events frequency | Determine the dose-safety response relationship of the ALK tree AIT. This information will, in combination with the evaluation of the allergy symptoms, form the basis of the conclusion on the primary endpoint. | Throughout the trial, an expected average of 8 months | Yes |
Secondary | Adverse events severity | Determine the dose-safety response relationship of the ALK tree AIT. This information will, in combination with the evaluation of the allergy symptoms, form the basis of the conclusion on the primary endpoint. | Throughout the trial, an expected average of 8 months | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06037148 -
Study to Evaluate Safety, Tolerability and Explorative Efficacy of DM-101PX in Birch Pollen Allergic Participants
|
Phase 1 | |
Completed |
NCT04912076 -
S.C. Immunotherapy With BM41 in Patients With Allergic Rhino-conjunctivitis Caused by Birch Pollen
|
Phase 1 | |
Recruiting |
NCT05346718 -
Threshold Concentrations for Ragweed and Birch Pollen in Seasonal Allergic Rhinitis
|
N/A | |
Completed |
NCT01137357 -
Probiotics for Reduction Of Markers In Subjects With Allergy
|
N/A | |
Active, not recruiting |
NCT05668390 -
Safety and Efficacy of STALORAL® Birch 300 IR in a Paediatric Population With Birch Pollen-induced ARC w/o Asthma
|
Phase 3 | |
Not yet recruiting |
NCT02146300 -
Effect of the Nasal Provocation on the Breathing Style
|
N/A | |
Completed |
NCT01449786 -
Sublingual Immunotherapy of Birch Pollen Associated Apple Allergy
|
Phase 2 | |
Completed |
NCT03969849 -
Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of a Single Dose of REGN5713-5714-5715 in Healthy Adult Participants
|
Phase 1 | |
Completed |
NCT04435678 -
Diagnostic Accuracy of the MADx Multi Array Xplorer (MAX 45k) Automated Laboratory System and the MADx Allergy Explorer Version 2 (ALEX²) - IgE Multiplex Test for the Diagnosis of Pre-defined Groups of Specific High-priority Allergens
|
N/A | |
Completed |
NCT01628484 -
Physiological Study to Determine the Allergic Skin Activity After Different Skin Preparation
|
Phase 1 | |
Completed |
NCT00932607 -
SUBLIVAC® Birch PROBE Study
|
Phase 2 | |
Completed |
NCT00266526 -
Specific Immunotherapy With Recombinant Birch Pollen Allergen rBet v1-FV
|
Phase 2 | |
Completed |
NCT02143583 -
Follow-up of Study AN004T to Assess the Persistence of AllerT Efficacy During the 2nd to 4th Season After Treatment
|
Phase 2 | |
Completed |
NCT02074930 -
Comparison of the Influence of Different Skin Conditions on the Allergic Skin Reactivity to Epicutanous Allergen Exposure
|
N/A | |
Completed |
NCT04266028 -
Study to Evaluate Safety and Tolerability of sc Immunotherapy With DM-101 in Adults With Birch Pollen Allergy
|
Phase 1 | |
Completed |
NCT00309062 -
Safety and Efficacy of Recombinant Birch Pollen Allergen in the Treatment of Allergic Rhinoconjunctivitis
|
Phase 3 |