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

Allergy Clinical Trial

Official title:

A Multicentre, Randomised, Double-blind, Placebo-controlled Parallel Group Clinical Trial to Investigate the Efficacy and Safety of Specific Sublingual Immunotherapy With SLITone Birch in Patients With Seasonal Birch Pollen Induced Rhinoconjunctivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310466
• Other study ID #: SHX0712
• Status: Completed
• Phase: Phase 3
• First received: April 2, 2006
• Last updated: April 29, 2013
• Start date: June 2005
• Est. completion date: January 2007

Study information

• Verified date: April 2013
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: January 2007
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Allergy

Intervention

Biological:
• Sublingual immunotherapy
once daily intake of sublingual drops
• Placebo
once daily intake of sublingual drops

Locations

Country	Name	City	State
Germany	Charité Klinik für Dermatologie, Venerologie und Allergologie	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Rhinoconjunctivitis Symptom Score	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.	Birch pollen season 2006	No
Primary	Daily Rhinoconjunctivitis Rescue Medication Score	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).	Birch pollen season 2006	No
Secondary	Global Improvement of Rhinoconjunctivitis Symptoms Assessed by the Subjects	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).	Birch pollen season 2006	No
Secondary	Adverse Events	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).	Birch pollen season 2006	Yes