CompletedPhase 3

Study of Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Adult Patients With Allergic Grass Pollen Rhinoconjunctivitis

United States473 participantsStarted 2008-10

Plain-language summary

The purpose of the study is to assess the efficacy and safety of 300 IR sublingual tablet of grass pollen allergen extract compared to placebo in adult patient with allergic rhinoconjunctivitis.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
✓. Positive SPT to grasses
✓. Total symptoms score for the previous pollen season more than 12 out of 18.
✓. Patients with FEV1 ≥ 80% of the predicted value.

Exclusion criteria

✕. Positive SPT to other grasses present during the grass pollen season and if endemic to the region
✕. Patients with clinically significant confounding symptoms of allergy to other allergens potentially overlapping the grass pollen season
✕. Asthma requiring treatment with medications other than beta-2 inhaled agonists.
✕. Patients who have received any desensitization treatment for grass pollen in the past 5 years.
✕. Ongoing immunotherapy with any other allergen.
✕. Patients with any nasal or oral condition that could confound the efficacy or safety assessments
✕. Patients with known history of hypersensitivity or intolerance to any of the excipients in the investigational product (such as lactose intolerance).
✕. Patients with any past or current clinically significant condition which as judged by the investigator, may affect the patient's participation or the outcome of the study.

What they're measuring

Combined Score (CS)

Timeframe: Pollen period (average of 42.8 days)

Trial details

NCT IDNCT00955825

SponsorStallergenes Greer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-08

Results submitted2016-01-25

View on ClinicalTrials.gov More Allergic Rhinitis Due to Grass Pollens trials