NCT00562159

Efficacy and Safety of Grass Sublingual Tablet in Adults (P05238 AM3)(COMPLETED)

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Grass (Phleum Pratense) Sublingual Tablet (SCH 697243) in Adult Subjects With a History of Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 439 (actual)
• Sponsor: ALK-Abelló A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This purpose of this study is to determine the efficacy and safety of a grass sublingual (under-the-tongue) tablet.

Detailed description

This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study in participants 18 to 65 years of age, of either sex, and of any race with a history of grass pollen induced rhinoconjunctivitis with or without asthma. While receiving treatment, participants will receive either grass sublingual tablet or placebo. Open-label rescue medications for the hinoconjunctivitis and asthma symptoms will be provided. Participants will visit the study site for at least 12 visits. A total of 10 allergic symptoms, 6 rhinoconjunctivitis and 4 lung symptoms, will be recorded daily on an electronic diary by the participant. The start and end of the grass pollen season (GPS) was determined based on the regional grass pollen count, and lasted up to 162 days. For each region, the GPS is defined as the first day of 3 consecutive recorded days with a grass pollen count of ≥ 10 grains/m\^3, to the last day of the last occurrence of 3 consecutive recorded days with a grass pollen count ≥ 10 grains/m\^3, inclusively.

Conditions

• Rhinoconjunctivitis
• Rhinitis
• Conjunctivitis
• Allergy

Interventions

Type	Name	Description
DRUG	Placebo	Placebo sublingual tablet
BIOLOGICAL	SCH 697243	SCH 697243 (2800 Bioequivalent Allergen Units \[BAU\] of Phleum pratense extract, containing approximately 15 mcg Phl p 5), administered sublingually once daily.
DRUG	Loratadine 10 mg Rescue Treatment	Loratadine 10 mg RediTabs tablets were dosed orally once daily as rescue medication among participants with a total symptom score ≥ 4 during the GPS.
DRUG	Olopatadine 0.1% Rescue Treatment	Olopatadine hydrochloride 0.1% ophthalmic solution was administered intraocularly at a dose of 1 drop in each affected eye twice daily as rescue medication for rhinoconjunctivitis, as needed.
DRUG	Mometasone 50 mcg Rescue Treatment	Mometasone furoate monohydrate nasal spray 50 mcg was admininstered intranasally at a dose of 2 sprays in each nostril once daily as rescue medication for rhinoconjunctivitis, as needed.
DRUG	Prednisone 5 mg Rescue Treatment	Prednisone 5 mg tablets were administered orally at a dose of 1 mg/kg/day (maximum 50 mg/day) on Day 1 and 0.5 mg/kg/day (maximum 25 mg/day) on Days 2, 3, 5 and 7 as rescue medication for rhinoconjunctivitis among participants with a total symptom score of ≥ 4 despite treatment with loratadine and mometasone furoate nasal spray.
DRUG	Albuterol sulfate 108 mcg	Albuterol sulfate inhalation aerosol 108 mcg/inhalation was administed via inhalation at a dose of 2 inhalations every 4 to 6 hours, as needed, as rescue medication for asthma.
DRUG	Fluticasone propionate 44 mcg	Fluticasone propionate inhalation aerosol 44 mcg/inhalation was administered via inhalation at a dose of two inhalations twice daily, to a maximum dose of 10 inhalations twice daily, as rescue medication for asthma among participants utilizing four or more albuterol sulfate inhalations/day for 2 days for nocturnal asthma or shortness of breath.
DRUG	Prednisone 5 mg	Prednisone 5 mg tablets were administered orally at a dose of 1 mg/kg/day (maximum 50 mg/day) on Day 1 and 0.5 mg/kg/day (maximum 25 mg/day) on Days 2, 3, 5 and 7 as rescue medication for asthma at the discretion of the investigator for the treatment of asthma exacerbation.

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2007-11-21
• Last updated: 2017-03-03
• Results posted: 2012-09-07