Clinical trial NCT00550550
Conditions: Rhinoconjunctivitis Rhinitis Conjunctivitis Allergy
Keywords: rhinoconjunctivitis rhinitis conjunctivitis allergy allergen immunotherapy
Sponsor: ALK-Abelló A/S
Start date: 2007-11-01; Completion date: 2009-09-01
Enrollment: 345 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to investigate the efficacy and safety of a grass sublingual tablet in children and adolescents with a history of grass-pollen induced rhinoconjunctivitis with or without asthma.

Detailed description:
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in participants aged 5 to \<18 years 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 rhinoconjunctivitis 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/parent/guardian.

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.

Arms: arm 1: Matching Placebo arm 2: Grass Sublingual Tablet (Phleum pratense extract)
Interventions: intervention 1: Placebo intervention 2: SCH 697243 intervention 3: Loratadine Syrup 1 mg/mL Rescue Treatment intervention 4: Loratadine 10 mg Rescue Treatment intervention 5: Olopatadine 0.1% Rescue Treatment intervention 6: Mometasone furoate 50 mcg Rescue Treatment intervention 7: Albuterol 108 mcg Rescue Treatment intervention 8: Fluticasone 44 mcg Rescue Treatment intervention 9: Prednisone 5 mg Rescue Treatment
Intervention descriptions: intervention 1: Placebo sublingual tablet, once daily intervention 2: Grass sublingual tablet, once daily intervention 3: Loratadine Syrup 1 mg/mL was dosed orally once daily at a dose of 5 mg for children aged 5 to \<6 years of age and at a dose of 10 mg for children aged 6 to \<18 years of age as rescue medication for symptoms of rhinoconjunctivitis among participants with a total symptom score ≥4. intervention 4: Loratadine 10 mg RediTabs tablets were dosed orally once daily at a dose of 10 mg for children aged 6 to \<18 years of age as rescue medication for symptoms of rhinoconjunctivitis among participants with a total symptom score ≥4. intervention 5: Olopatadine hydrochloride 0.1% ophthalmic solution was dosed intraocularly at a dose of 1 drop in each affected eye twice daily, in addition to loratadine, as rescue medication for participants with persistent eye symptoms due to rhinoconjunctivitis. intervention 6: Mometasone furoate monohydrate nasal spray 50 mcg was dosed intranasally at a dose of one spray in each nostril once daily for participants aged 5 to \<12 years and a dose of 2 sprays in each nostril once daily for participants aged 12 to \<18 years as rescue medication for nasal symptoms of rhinoconjunctivitis among participants with a total symptom score of ≥4 despite loratadine and mometasone furoate nasal spray. intervention 7: Albuterol sulfate inhalation aerosol 108 mcg/inhalation was administered via inhalation at a dose of 2 inhalations every 4 to 6 hours as rescue medication among participants aged 5 to \<18 years with asthma symptoms . intervention 8: Fluticasone propionate inhalation aerosol 44 mcg/inhalation was administered via inhalation at a dose of 2 inhalations twice daily among participants aged 12 to \<18 years up to a maximum dose of 10 inhalations twice daily, in combination with albuterol, among participants with ≥4 albuterol sulfate inhalations/day for 2 days as rescue medication for nocturnal asthma or shortness of breath. intervention 9: Prednisone tablet 5 mg was administered orally at a dose of 1 mg/kg/day once daily up to a maximum of 50 mg/day on Day 1, and at a dose of 0.5 mg/kg/day once daily up to a maximum of 25 mg/day on Days 2, 3, 5, and 7 as rescue medication for asthma exacerbation at the discretion of the investigator.

Protocol documents: