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

Allergopharma

Status and phase: Completed; Phase 2

Conditions: Type I-Allergy

Treatments: Biological: rPhleum; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00666341

2007-002808-18 (EudraCT Number)

AL0701rP

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo

20 μg rPhleum Immunotherapy

Experimental group

Description:

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

Treatment:

Biological: rPhleum

Biological: rPhleum

Biological: rPhleum

Biological: rPhleum

40 μg rPhleum Immunotherapy

Experimental group

Description:

Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg)

Treatment:

Biological: rPhleum

Biological: rPhleum

Biological: rPhleum

Biological: rPhleum

80 μg rPhleum Immunotherapy

Experimental group

Description:

Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg)

Treatment:

Biological: rPhleum

Biological: rPhleum

Biological: rPhleum

Biological: rPhleum

120 μg rPhleum Immunotherapy

Experimental group

Description:

Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg)

Treatment:

Biological: rPhleum

Biological: rPhleum

Biological: rPhleum

Biological: rPhleum