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NCT00671268 Clinical Trial

Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma

Rhinoconjunctivitis Clinical Trial

— AMETHYST  

Official title:
Multicentre, Multinational Randomised DBPC Clinical Trial for Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00671268
Other study ID # AL0704rP
Secondary ID 2007-003208-37
Status Completed
Phase Phase 3
First received April 23, 2008
Last updated November 7, 2013
Start date March 2008
Est. completion date March 2013

Study information
Verified date November 2013
Source Allergopharma GmbH & Co. KG
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial Summary

Efficacy and Safety from a high-dosed subcutaneous recombinant preparation

Recruitment information / eligibility
Status Completed
Enrollment 256
Est. completion date March 2013
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Allergic rhinoconjunctivitis attributable to grass pollen

- Positive SPT

- Positive EAST

- Positive provocation test

Exclusion Criteria:

- serious disease

- other perennial allergies

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• AL0704rP
strict subcutaneous
• Placebo
strict subcutaneous

Locations
Country Name City State
Germany Allergopharma GmbH & Co. KG Reinbek

Sponsors (1)
Lead Sponsor Collaborator
Allergopharma GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of Symptom and Medication score during the baseline and the following two pollen seasons No
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