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Completed

NCT Number: NCT00310466

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

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

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Key information

Conditions

Allergy Hypersensitivity Immune System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Charité Klinik für Dermatologie, Venerologie und Allergologie

Berlin, State of Berlin, D-10117, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sublingual immunotherapy

Biological

once daily intake of sublingual drops

Other names: SLITone(TM) Birch

Placebo

Biological

once daily intake of sublingual drops

Primary outcomes

  1. Daily Rhinoconjunctivitis Symptom Score

    Time frame: 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.

  2. Daily Rhinoconjunctivitis Rescue Medication Score

    Time frame: 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 outcomes

  1. Global Improvement of Rhinoconjunctivitis Symptoms Assessed by the Subjects

    Time frame: 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).

  2. Adverse Events

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Apr 4, 2006
Registry last updated
May 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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