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 AM3) - Full Text View

Purpose

This study will evaluate the efficacy and safety of ragweed sublingual tablet compared with placebo in participants with ragweed-induced rhinoconjunctivitis over a one year period. It is expected that ragweed allergic participants on one of the active arms of the trial will have decreased allergic rhinoconjunctivitis symptoms and require less allergy rescue medications during ragweed pollen season.

Condition	Intervention	Phase
Rhinitis Allergic, Conjunctivitis	Biological: 6 Amb a 1-U Biological: 12 Amb a 1-U Biological: Placebo	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 39641) in Adult Subjects With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma Pinkeye

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Combined (sum of) rhinoconjunctivitis daily symptom score (DSS) and daily medication score (DMS) averaged over the peak ragweed season (RS) [ Time Frame: The period during the ragweed season with the highest moving pollen average ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Average combined rhinoconjunctivitis DSS and DMS over the entire RS [ Time Frame: Approximately 5 weeks ] [ Designated as safety issue: No ]
Average rhinoconjunctivitis DSS for the peak RS [ Time Frame: The period during the ragweed season with the highest moving pollen average ] [ Designated as safety issue: No ]
Average rhinoconjunctivitis DSS for the entire RS [ Time Frame: The period during the ragweed season with the highest moving pollen average ] [ Designated as safety issue: No ]
Average rhinoconjunctivitis DMS for the peak RS [ Time Frame: The period during the ragweed season with the highest moving pollen average ] [ Designated as safety issue: No ]

Enrollment:	565
Study Start Date:	September 2009
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 6 Amb a 1-U	Biological: 6 Amb a 1-U Ambrosia artemisiifolia allergen extract, 6 Amb a 1-U, rapidly dissolving tablet, administered once daily sublingually Other Name: SCH 39641
Experimental: 12 Amb a 1-U	Biological: 12 Amb a 1-U Ambrosia artemisiifolia allergen extract, 12 Amb a 1-U, rapidly dissolving tablet, administered once daily sublingually Other Name: SCH 39641
Placebo Comparator: Placebo	Biological: Placebo Placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablet, administered once daily sublingually

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00783198 History of Changes
Other Study ID Numbers:	P05233, 2008-003863-38
Study First Received:	October 30, 2008
Last Updated:	July 7, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Conjunctivitis
Rhinitis
Conjunctival Diseases
Eye Diseases

Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013