Efficacy and Safety of Grass Pollen Sublingual Immunotherapy | NCT00567346 | Trialant

Efficacy and Safety of Grass Pollen Sublingual Immunotherapy | NCT00567346 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
grass pollen extract twice weekly	Active Comparator	Current standard dose regimen of grass pollen immunotherapy (9,500 BU), given twice weekly. Note: patients in twice weekly dosing regimen will also receive placebo on days no active treatment is given.	Drug: Oralgen
Grass pollen extract, daily	Active Comparator	Grass pollen immunotherapy, 9,500 BU, given daily	Drug: Oralgen
Increased dose of grass pollen extract	Active Comparator	Increased dose of grass pollen immunotherapy, 19,000 BU, given daily	Drug: Oralgen
Placebo control	Placebo Comparator	Patients randomized to placebo will receive placebo daily.	Drug: grass pollen extract

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oralgen	Drug	Patients will receive drops of grass pollen immunotherapy sublingually	Grass pollen extract, daily Increased dose of grass pollen extract

Outcomes Module

Secondary Outcomes

Measure	Description	Time Frame
Diarised Period RTSS on severity of rhinoconjunctivitis scores and rescue medication usage will be calculated to assess efficacy. Safety will be assessed through AE profile, the assessment of routine safety tests.		one year

Eligibility Module

Contacts/Locations Module