Clinical trial NCT00978029: Safety Study of Ragweed Allergy Immunotherapy Tablet in Subjects 50 Years of Age and Older (Study P06081)
Official title: A 28-Day Study Evaluating the Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 39641) in Adult Subjects 50 Years of Age and Older With Ragweed-Induced Rhinoconjunctivitis (Protocol No. P06081)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhinoconjunctivitis
Rhinitis
Conjunctivitis
Allergy
Keywords: immunotherapy
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2009-09-16
Enrollment: 203
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 with ragweed-induced rhinoconjunctivitis, with or without asthma.


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.

Primary outcomes:
measure: The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs)
timeFrame: Up to Day 42
Secondary outcomes:
measure: Proportion of Participants Reporting Oral Pruritus
timeFrame: Up to Day 42
measure: Proportion of Participants Reporting Ear Pruritus
timeFrame: Up to Day 42
measure: Proportion of Participants Reporting Throat Irritation
timeFrame: Up to Day 42
measure: Proportion of Participants Reporting Mouth Oedema
timeFrame: Up to Day 42
measure: Proportion of Participants Who Discontinued Due to Adverse Events.
timeFrame: Up to Day 28
Other outcomes:
Locations:
Study officials:
References:
citation: Nolte H, Amar N, Bernstein DI, Lanier BQ, Creticos P, Berman G, Kaur A, Hebert J, Maloney J. Safety and tolerability of a short ragweed sublingual immunotherapy tablet. Ann Allergy Asthma Immunol. 2014 Jul;113(1):93-100.e3. doi: 10.1016/j.anai.2014.04.018. Epub 2014 May 14.