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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00666341

Enrollment

Registered

2008-04-24

Start date

2007-09-30

Completion date

2010-05-31

Last updated

2013-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type I-Allergy

Brief summary

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

Interventions

DRUGplacebo

Placebo: Al(OH)3-Placebos with histamine-dihydrochloride analogue Allergen-Adsorbate rPhleum strengthes 1 to 4.

BIOLOGICALrPhleum

Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 1 (20 μg)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026