Dose-Response-Study With a Recombinant Cocktail of Phleum (rPhleum) Allergens

Phase 2

Completed

• Conditions: Type I-Allergy
• Interventions: Biological: rPhleum; Drug: placebo

• Registration Number: NCT00666341
• Lead Sponsor: Allergopharma GmbH & Co. KG

Brief Summary

Dose-response trial with a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense)

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-04-21
• Study First Submitted QC: 2008-04-23
• Study First Posted: 2008-04-24
• Primary Completion: 2009-01
• Study Completion: 2010-05
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• main symptoms of allergic rhinitis/rhinoconjunctivitis with or without controlled asthma against grass pollen allergens
• positive SPT
• positive EAST
• positive specific provocation test

Exclusion Criteria

• serious chronic diseases
• other perennial allergies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
20 μg rPhleum Immunotherapy	rPhleum	Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 1 (20 μg)
40 μg rPhleum Immunotherapy	rPhleum	Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg)
80 μg rPhleum Immunotherapy	rPhleum	Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg)
120 μg rPhleum Immunotherapy	rPhleum	Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg)
Placebo	placebo	Placebo: Al(OH)3-Placebos with histamine-dihydrochloride analogue Allergen-Adsorbate rPhleum strengthes 1 to 4.

Primary Outcome Measures

Name	Time	Method
Systemic reaction (according to Tryba)	uptitration phase	Number of patients with at least one systemic reaction (according to Tryba Grade 1-4) with possible, probable or definite relationship to the study medication determined at the end of the uptitration phase.

Secondary Outcome Measures

Name	Time	Method
Late Phase Reactions	before and at the end of the double-blind phase	Changes of the Late Phase Reactions in specific intracutaneous test with natural allergen before and at the end of the double-blind placebo controlled phase before grass pollen season.

Trial Locations

Locations (1)

Prof. Dr. med. Ludger Klimek; 🇩🇪 Wiesbaden, Baden-W., Germany