NCT00263627

Brief Summary

The aim of this clinical trial is to show safety and efficacy of the allergoid preparation of birch pollen allergens in the treatment of birch allergic patients in a representative number of patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
253

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_3

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

July 3, 2014

Status Verified

November 1, 2013

Enrollment Period

2 years

First QC Date

December 8, 2005

Last Update Submit

July 2, 2014

Conditions

Pollen Allergy

Keywords

specific immunotherapybirch pollen allergyAllergovit

Outcome Measures

Primary Outcomes (1)

  • Symptom Medication Score (SMS)

    The primary endpoint was the area under the curve (AUC) of the daily sum of the Symptom Medication Score (SMS) after two years of double-blind treatment. Each patient recorded the information used for deriving the SMS over a period of eight to twelve weeks during the two double-blind pollen seasons in 2006 and 2007.

    over a period of eight to twelve weeks during the two pollen seasons in

Secondary Outcomes (1)

  • Adverse events (AEs)

    Entrire study period.

Other Outcomes (1)

  • Well days

    Entire diary period

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Sterile aluminium hydroxide suspension for subcutaneous injection were applied in the upper arm. Vials with strength A contained 0.0125 mg/mL and with strength B 0.125 mg/mL histamine-dihydrochloride and strength 0 was produced by dilution of strength A. The vials containing the placebo solution were identical in their outer appearance with the active study preparation of the birch pollen allergoids.

Other: Placebo

Specific Immunotherapy

EXPERIMENTAL

Subcutaneous injections with birch pollen allergoid were applied in the upper arm. Vials with three different concentrations were used: Strength A (1000 TU/mL), strength B (10 000 TU/mL) and strength 0 (100 TU/mL) by dilution of strength A.

Biological: Birch pollen allergoid

Interventions

Birch pollen allergoidBIOLOGICAL

Subcutaneous injections were applied in the upper arm. Vials with three different concentrations were used: Strength A (1000 TU/mL), strength B (10 000 TU/mL) and strength 0 (100 TU/mL) by dilution of strength A.

Also known as: specific immunotherapy
Specific Immunotherapy
PlaceboOTHER

Sterile aluminium hydroxide suspension for subcutaneous injection were applied in the upper arm. Vials with strength A contained 0.0125 mg/mL and with strength B 0.125 mg/mL histamine-dihydrochloride and strength 0 was produced by dilution of strength A. The vials containing the placebo solution were identical in their outer appearance with the active study preparation of the birch pollen allergoids.

Also known as: Comparator
Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Rhinitis
  • Rhinoconjunctivitis
  • Positive skin prick test to birch pollen
  • Positive radioallergosorbent test (RAST) to birch pollen
  • Positive provocation test result to birch pollen

You may not qualify if:

  • Serious chronic diseases
  • Other perennial allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allergopharma Joachim Ganzer KG

Reinbek, 21465, Germany

Location

Related Links

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Annemie Narkus, M.D.

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 8, 2005

First Posted

December 9, 2005

Study Start

June 1, 2005

Primary Completion

June 1, 2007

Study Completion

March 1, 2010

Last Updated

July 3, 2014

Record last verified: 2013-11

Locations

DE(1)