NCT00310466

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

August 6, 2009

Completed
Last Updated

May 14, 2013

Status Verified

April 1, 2013

Enrollment Period

1.2 years

First QC Date

April 2, 2006

Results QC Date

March 12, 2009

Last Update Submit

April 29, 2013

Conditions

Allergy

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (2)

  • Global Improvement of Rhinoconjunctivitis Symptoms Assessed by the Subjects

    Birch pollen season 2006

  • Adverse Events

    Birch pollen season 2006

Study Arms (2)

Sublingual immunotherapy

ACTIVE COMPARATOR

sublingual immunotherapy with drops applied once daily by single dose containers (200 STU per dose)

Biological: Sublingual immunotherapy

Placebo

PLACEBO COMPARATOR

placebo sublingual drops

Biological: Placebo

Interventions

Sublingual immunotherapyBIOLOGICAL

once daily intake of sublingual drops

Also known as: SLITone(TM) Birch
Sublingual immunotherapy
PlaceboBIOLOGICAL

once daily intake of sublingual drops

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Klinik für Dermatologie, Venerologie und Allergologie

Berlin, State of Berlin, D-10117, Germany

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Sublingual Immunotherapy

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Desensitization, ImmunologicImmunosuppression TherapyImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Limitations and Caveats

Clinical improvement following SLIT is thought to be due to immunological mechanisms that develop over time. Even though clear immunological changes were observed in this trial it appears that the treatment was too short to reach full clinical effect

Results Point of Contact

Title
Kim Simonsen, Senior Director
Organization
ALK-Abelló A/S
+4545747576

Study Officials

  • Hendrik Wolf, PhD

    ALK-SCHERAX Arzneimittel GmbH

    STUDY DIRECTOR

  • Margitta Worm, MD, Prof.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2006

First Posted

April 4, 2006

Study Start

June 1, 2005

Primary Completion

August 1, 2006

Study Completion

January 1, 2007

Last Updated

May 14, 2013

Results First Posted

August 6, 2009

Record last verified: 2013-04

Locations

DE(1)