Efficacy and Safety Study Of Short Ragweed Pollen Sublingual-Oral Immunotherapy

Stallergenes Greer

Status and phase: Completed; Phase 3

Conditions: Allergy

Treatments: Biological: Short Ragweed Pollen Allergenic Extract; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01353079

SLIT10-01

Details and patient eligibility

About

The primary objective of this study is to demonstrate that SLIT administered pre-and co-seasonally is effective in reducing rhinoconjunctivitis symptoms during the entire short ragweed pollen season.

Enrollment: 429 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• allergic to ragweed

Exclusion criteria

• not allergic to ragweed
• history of anaphylaxis
• subject with chronic sinusitis, unstable angina, significant arrhythmia, uncontrolled hypertension, or other chronic or immunological disease
• Asthmatic subjects with FEV1 or PEF less than or equal to 80% predicted
• Subjects who have received experimental drug within 30 days prior to study admission
• Subjects who have received anit-IgE medications in the last 12 months
• Subjects who have received ragweed immunotherapy in the last 3 years
• Subjects who are currently users of inhaled, intramuscular, or intravenous corticosteroids, tricyclic anti-depressants, beta blockers, and MAO inhibitors
• Subjects refusing to sign epi-pen training form
• Females who are pregnant or breast feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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429 participants in 2 patient groups, including a placebo group

Short Ragweed Pollen Allergenic Extract

Experimental group

Treatment:

Biological: Short Ragweed Pollen Allergenic Extract

Glycero-COCAs

Placebo Comparator group

Treatment:

Biological: Placebo