Study: NCT00562159

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo sublingual tablet

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: SCH 697243
Description: SCH 697243 (2800 Bioequivalent Allergen Units \[BAU\] of Phleum pratense extract, containing approximately 15 mcg Phl p 5), administered sublingually once daily.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Loratadine 10 mg Rescue Treatment
Description: Loratadine 10 mg RediTabs tablets were dosed orally once daily as rescue medication among participants with a total symptom score ≥ 4 during the GPS.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Loratadine 10 mg Rescue Treatment
Description: Loratadine 10 mg RediTabs tablets were dosed orally once daily as rescue medication among participants with a total symptom score ≥ 4 during the GPS.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Olopatadine 0.1% Rescue Treatment
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Olopatadine 0.1% Rescue Treatment
Description: 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.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Mometasone 50 mcg Rescue Treatment
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mometasone 50 mcg Rescue Treatment
Description: 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.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Prednisone 5 mg Rescue Treatment
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prednisone 5 mg Rescue Treatment
Description: 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.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Albuterol sulfate 108 mcg
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Albuterol sulfate 108 mcg
Description: 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.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Fluticasone propionate 44 mcg
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fluticasone propionate 44 mcg
Description: 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.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Prednisone 5 mg
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prednisone 5 mg
Description: 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.