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

Completed · Phase 3 · Has a placebo group

Conditions studied: Allergy

In brief

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.

Key facts

Study ID

NCT01353079

Run by

Greer Laboratories

People needed

429

Starts

2011-04-01

Expected to finish

2012-04-01

Last updated by the study team

2015-02-05

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• allergic to ragweed

You may not qualify if…

• 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

Where it is running

• Site 7 — Warrenton, Virginia, United States

Full record on ClinicalTrials.gov

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