Status:
COMPLETED
Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet in Adults With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (Study P05233)(COMPLETED)
Lead Sponsor:
ALK-Abelló A/S
Conditions:
Rhinitis; Allergic, With Asthma
Conjunctivitis
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
PHASE3
Brief Summary
This study will evaluate the efficacy and safety of ragweed sublingual tablet (SCH 39641/MK-3641) compared with placebo in participants with ragweed-induced rhinoconjunctivitis over a one-year period....
Eligibility Criteria
Inclusion
- Must have a clinical history of significant ragweed-induced allergic rhinoconjunctivitis of at least 2 years duration, with or without asthma and have received treatment during the previous RS.
- Must have a positive skin prick test response to Ambrosia artemisiifolia at Screening Visit.
- Must be positive for specific immunoglobulin E (IgE) against Ambrosia artemisiifolia at Screening Visit.
- Must have an forced expiratory volume in 1 second (FEV1) of at least 70% of predicted at Screening Visit.
- Safety laboratory tests and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor
Exclusion
- Clinical history of symptomatic seasonal allergic rhinitis and/or asthma having received regular medication, due to another allergen during or potentially overlapping the RS.
- Clinical history of significant symptomatic perennial allergic rhinitis and/or asthma due to an allergen to which the participant is regularly exposed.
- Receipt of an immunosuppressive treatment within 3 months prior to the Screening Visit (except steroids for allergic and asthma symptoms).
- Clinical history of severe asthma.
- Asthma requiring medium or high dose inhaled corticosteroids.
- History of anaphylaxis with cardiorespiratory symptoms.
- History of chronic urticaria and angioedema.
- Clinical history of chronic sinusitis 2 years prior to the Screening Visit.
- Current severe atopic dermatitis.
- Breast-feeding, pregnant, or intending to become pregnant.
- Had previous treatment by immunotherapy with ragweed allergen or any other allergen 5 years prior to Screening Visit.
- History of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (except for Ambrosia artemisiifolia), rescue medications, or self-injectable epinephrine.
- History of self-injectable epinephrine use.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
565 Patients enrolled
Trial Details
Trial ID
NCT00783198
Start Date
September 1 2009
End Date
May 1 2011
Last Update
March 3 2017
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