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

Summary

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

Conditions

• Rhinoconjunctivitis
• Rhinitis
• Conjunctivitis
• Allergy

Interventions

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.

Sponsors & Collaborators

• ALK-Abelló A/S

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-11-30

Primary Completion

2009-09-30

Completion

2009-09-30