Efficacy and Safety Trial of SLITone(TM) Birch in Subjects With Hayfever

Phase 3

Completed

• Conditions: Allergy
• Interventions: Biological: Sublingual immunotherapy; Biological: Placebo

• Registration Number: NCT00310466
• Lead Sponsor: ALK-Abelló A/S

Brief Summary

The trial is performed to assess the efficacy and safety of SLIT One birch for treatment of birch pollen induced allergy

Detailed Description

Daily rhinoconjunctivits symptom and medication scores from patient diaries, adverse events

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2006-04-02
• Study First Submitted QC: 2006-04-02
• Study First Posted: 2006-04-04
• Primary Completion: 2006-08
• Study Completion: 2007-01
• Results First Submitted: 2009-03-12
• Results First Submitted QC: 2009-06-19
• Results First Posted: 2009-08-06
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-29
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

Inclusion Criteria

• A history of birch pollen allergy
• Positive skin prick test to birch
• Positive conjunctival test to birch
• Positive specific Immunoglobulin E (IgE) to birch

Exclusion Criteria

• Forced expiratory volume in 1 second (FEV1)<70% of predicted value
• History of seasonal allergy interfering with study
• History of symptomatic perennial allergy
• History of emergency visit or admission for asthma in the previous 12 month

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sublingual immunotherapy	Sublingual immunotherapy	sublingual immunotherapy with drops applied once daily by single dose containers (200 STU per dose)
Placebo	Placebo	placebo sublingual drops

Primary Outcome Measures

Name	Time	Method
Daily Rhinoconjunctivitis Symptom Score	Birch pollen season 2006	A total of 6 rhinoconjunctivitis symptoms are recorded (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, watery eyes). Each symptoms is scored on a scale from 0-3 (no symptoms-severe symptoms). I.e. the total daily score can be 0-18.
Daily Rhinoconjunctivitis Rescue Medication Score	Birch pollen season 2006	Rescue medication (desloratadine tablets, budesonide nasal spray, prednisone tablets) used for treatment of rhinoconjunctivitis symptoms not controlled by the study medication, were recorded. The total daily score was 0-30 (No medication-Maximum use of medication).

Secondary Outcome Measures

Name	Time	Method
Global Improvement of Rhinoconjunctivitis Symptoms Assessed by the Subjects	Birch pollen season 2006	The number of participants who reported improved overall symptoms compared to the previous birch pollen season (each patient was asked to compare his/her symptoms in the 2006 birch pollen season with the symptoms in the 2005 birch pollen season).
Adverse Events	Birch pollen season 2006	An adverse event was defined as: Any untoward medical occurence in a patient or clinical trial subject administered a trial product and which does not necessarily have a causal relationship with this treatment (International Conference of Harmonisation (ICH) Harmonised Tripartite Guideline E2A, Step 5).

Trial Locations

Locations (1)

Charité Klinik für Dermatologie, Venerologie und Allergologie; 🇩🇪 Berlin, Germany