Phase 2 Completed N=196 Randomized Triple-blind Treatment

Safety Study of Ragweed Allergy Immunotherapy Tablet in Subjects 50 Years of Age and Older (Study P06081)

Rhinoconjunctivitis · Rhinitis · Conjunctivitis · allergy

Source: ClinicalTrials.gov NCT00978029 ↗

Enrolled (actual)

196

Serious AEs

0.5%

Results posted

May 2014

Primary outcomePrimary: The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs) — 0.446; 0.515; 0.615 Proportion of Participants — p=0.486

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 with ragweed-induced rhinoconjunctivitis, with or without asthma.

Outcome Measures

Outcome	Result	p-value
PRIMARY The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs)	0.446; 0.515; 0.615	0.486
SECONDARY Proportion of Participants Reporting Oral Pruritus	0.015; 0.167; 0.169	—
SECONDARY Proportion of Participants Reporting Ear Pruritus	0; 0.061; 0.077	—
SECONDARY Proportion of Participants Reporting Throat Irritation	0.015; 0.121; 0.077	—
SECONDARY Proportion of Participants Reporting Mouth Oedema	0; 0.015; 0	—
SECONDARY Proportion of Participants Who Discontinued Due to Adverse Events.	0.015; 0.03; 0.077	—

Eligibility Criteria

Inclusion Criteria

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 Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00978029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.