drugset / Trial / NCT00550550
Efficacy and Safety of Grass Sublingual Tablet in Children and Adolescents (P05239 AM3)(COMPLETED)
RandomizedParallel-groupQuadruple-blindTreatment
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
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 |