NCT00666341

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

A Double-blind Placebo-controlled Dose-response Study for Evaluation of Safety and Efficacy of Immunotherapy With a Cocktail of Recombinant Major Allergens of Timothy Grass Pollen (Phleum Pratense) Adsorbed to Aluminium Hydroxide in Patients With IgE-mediated Allergic Rhinitis/Rhinoconjunctivitis With or Without Bronchial Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Allergopharma GmbH & Co. KG · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Type I-Allergy

Interventions

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

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-01-01
• Completion: 2010-05-01
• First posted: 2008-04-24
• Last updated: 2013-11-08

Locations

1 site across 1 country: Germany