Status:
COMPLETED
Safety Study of Ragweed Allergy Immunotherapy Tablet in Subjects 50 Years of Age and Older (Study P06081)
Lead Sponsor:
ALK-Abelló A/S
Conditions:
Rhinoconjunctivitis
Rhinitis
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The purpose of this study was to assess the safety and tolerability of a ragweed allergy immunotherapy tablet (AIT) administered sublingually (under-the tongue) in subjects 50 years of age and older w...
Eligibility Criteria
Inclusion
- Subject must be 50 years of age or older, of either sex, and of any race/ethnicity.
- Subject must have a clinical history of ragweed-induced allergic rhinoconjunctivitis with or without asthma.
- Subject must have a positive skin prick test response to Ambrosia artemisiifolia at the Screening Visit
- Subject must have a forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at the Screening Visit and at Randomization.
- A subject's clinical laboratory tests, electrocardiogram (ECG) and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator.
Exclusion
- Subject with asthma who requires inhaled corticosteroids for the treatment of their asthma during the study period.
- Subject requiring anti-allergy medications during the time period from randomization to study completion.
- Subject who has received an immunosuppressive treatment within 3 months prior to the Screening Visit (except steroids for allergic and asthma symptoms).
- Subject with a history of anaphylaxis with cardiorespiratory symptoms.
- Subject with a history of chronic urticaria or angioedema.
- Subject with current severe atopic dermatitis.
- Female subject who is breastfeeding, pregnant, or intending to become pregnant.
- Subject with a history of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (IMPs) (except for Ambrosia artemisiifolia), or self-injectable epinephrine.
- Subject with a history of self-injectable epinephrine use.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT00978029
Start Date
November 1 2009
End Date
February 1 2010
Last Update
March 3 2017
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