A Multicentre Randomised Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Allergoid Preparation of Birch Pollen Allergens
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
253
1 country
1
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2007
Actual (reported)Study Completion
March 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2010
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
December 8, 2005
Actual (reported)December 9, 2005
Actual (reported)June 2007
Actual (reported)March 2010
Actual (reported)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
Adverse events (AEs)
Entrire study period.
Well days
Entire diary period
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.
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.
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.
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.
Allergopharma Joachim Ganzer KG
Reinbek, 21465, Germany
Annemie Narkus, M.D.
253 participants (actual enrollment reported by the registry).
First Submitted
December 8, 2005
First Posted
December 9, 2005
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR)(P04579)
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Primary Completion
June 2007
Actual (reported)Study Completion
March 2010
Actual (reported)Last Updated
July 3, 2014
Record last verified: 2013-11
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Source: ClinicalTrials.gov.
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