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.

Timeline

Start

2007-11

Primary completion

2009-09

Completion

2009-09

Outcome

Met primary endpoint

registry SCH 697243 vs Placebo; p =0.001; Mean Difference (Final Values) -1.63 (95% CI -2.60 to -0.66) NCT00550550 ↗

paper TCS, DSS, DMS, and Rhinoconjunctivitis Quality of Life Questionnaire score versus placebo improved 26% (P = .001) PMID 21211642 ↗

Publications

• Results Blaiss M, Maloney J, Nolte H, Gawchik S, Yao R, Skoner DP. Efficacy and safety of timothy grass allergy immunotherapy tablets in North American children and adolescents. J Allergy Clin Immunol. 2011 Jan;127(1):64-71, 71.e1-4. doi: 10.1016/j.jaci.2010.11.034.
• Hebert J, Blaiss M, Waserman S, Kim H, Creticos P, Maloney J, Kaur A, Li Z, Nelson H, Nolte H. The efficacy and safety of the Timothy grass allergy sublingual immunotherapy tablet in Canadian adults and children. Allergy Asthma Clin Immunol. 2014 Oct 30;10(1):53. doi: 10.1186/1710-1492-10-53. eCollection 2014.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SCH 697243	Other / unclassified	2800 unknown	Other
Background	Fluticasone	Other / unclassified	44 ug	Inhaled
Background	Loratadine	Small molecule	5 mg	Oral
Background	Loratadine	Small molecule	10 mg	Oral
Background	Mometasone furoate	Other / unclassified	50 ug	Other
Background	Olopatadine	Other / unclassified	0.1 %	Other
Background	Prednisone	Other / unclassified	0.5 mg/kg	Oral
Background	Salbutamol	Unknown	108 ug	Inhaled

Indications