Efficacy and Safety of Grass Sublingual Tablet in Children and Adolescents (P05239 AM3)(COMPLETED)

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.

Conditions

• Rhinoconjunctivitis
• Rhinitis
• Conjunctivitis
• Allergy

Interventions

DRUG

Placebo

Placebo sublingual tablet, once daily

BIOLOGICAL

SCH 697243

Grass sublingual tablet, once daily

DRUG

Loratadine Syrup 1 mg/mL Rescue Treatment

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.

DRUG

Loratadine 10 mg Rescue Treatment

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.

DRUG

Olopatadine 0.1% Rescue Treatment

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.

DRUG

Mometasone furoate 50 mcg Rescue Treatment

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.

DRUG

Albuterol 108 mcg Rescue Treatment

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 .

DRUG

Fluticasone 44 mcg Rescue Treatment

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.

DRUG

Prednisone 5 mg Rescue Treatment

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.

Sponsors & Collaborators

• ALK-Abelló A/S

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-11-30

Primary Completion

2009-09-30

Completion

2009-09-30