Sublingual-oral administration of standardized allergenic extracts: Phase 1 safety and dosing results

Annals of Allergy, Asthma and Immunology

Volumn 100, Issue 5, 2008, Pages 475-481

  Esch, Robert E ^a   Bush, Robert K ^b   Peden, David ^c   Lockey, Richard F ^d  

^a Greer Laboratories   (United States)

^b UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

^c UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^d UNIVERSITY OF SOUTH FLORIDA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALLERGEN; CAT HAIR ALLERGENIC EXTRACT; HOUSE DUST ALLERGEN; PLACEBO; SHORT RAGWEED POLLEN EXTRACT; TIMOTHY GRASS POLLEN EXTRACT;

ADULT; ALLERGIC RHINITIS; ARTICLE; ASTHMA; CAT; CLINICAL TRIAL; CONTROLLED STUDY; DERMATOPHAGOIDES; DISEASE SEVERITY; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ELECTRONICS; FEMALE; GRASS POLLEN; HAIR; HUMAN; IMMUNOTHERAPY; MAJOR CLINICAL STUDY; MALE; PATIENT COMPLIANCE; PHASE 1 CLINICAL TRIAL; PHLEUM PRATENSE; PRIORITY JOURNAL; RAGWEED POLLEN; STANDARDIZATION; SUBLINGUAL ALLERGEN IMMUNOTHERAPY; TREATMENT OUTCOME; UNITED STATES; UNSPECIFIED SIDE EFFECT;

EID: 43449109484     PISSN: 10811206     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1081-1206(10)60474-7     Document Type: Article

References (36)

1. MS Dykewicz S Fineman DP Skoner Diagnosis and management of rhinitis: complete guidelines of the Joint Task Force on Practice Parameters in Allergy, Asthma and Immunology: American Academy of Allergy, Asthma, and Immunology Ann Allergy Asthma Immunol 81 1998 478 518
2. EO Meltzer Quality of life in adults and children with allergic rhinitis J Allergy Clin Immunol 108 2001 S45 S53
3. M Calderon B Alves M Jacobson B Hurwitz A Sheikh S Durham Allergen injection immunotherapy for seasonal allergic rhinitis Cochrane Database Syst Rev 1 2007 CD001936.
4. H Mosbech O Osterballe Does the effect of immunotherapy last after termination of treatment? follow-up study in patients with grass pollen rhinitis Allergy 43 1988 523 529
5. L Jacobsen B Nuchel Petersen JA Wihl H Lowenstein H Ipsen Immunotherapy with partially purified and standardized tree pollen extracts, IV: results from long-term (6-year) follow-up Allergy 52 1997 914 920
6. G Hedlin H Heilborn G Lilja Long-term follow-up of patients treated with a three-year course of cat or dog immunotherapy J Allergy Clin Immunol 96 1995 879 885
7. SR Durham SM Walker EM Varga Long-term clinical efficacy of grass-pollen immunotherapy N Engl J Med 341 1999 468 475
8. A Des Roches L Paradis JL Menardo S Bouges JP Daures J Bousquet Immunotherapy with a standardized Dermatophagoides pteronyssinus extract, VI: specific immunotherapy prevents the onset of new sensitizations in children J Allergy Clin Immunol 99 1997 450 453
9. PA Eng M Reinhold HP Gnehm Long-term efficacy of preseasonal grass pollen immunotherapy in children Allergy 57 2002 306 312
10. PA Eng M Borer-Reinhold IA Heijnen HP Gnehm Twelve-year follow-up after discontinuation of preseasonal grass pollen immunotherapy in childhood Allergy 61 2006 198 201
11. M Marogna M Bruno A Massolo P Falagiani Long-lasting effects of sublingual immunotherapy for house dust mites in allergic rhinitis with bronchial hyperreactivity: a long-term (13-year) retrospective study in real life Int Arch Allergy Immunol 142 2007 70 78
12. CM Reha A Ebru Specific immunotherapy is effective in the prevention of new sensitivities Allergol Immunopathol (Madr) 35 2007 44 51
13. B Niggemann L Jacobsen S Dreborg Five-year follow-up on the PAT study: specific immunotherapy and long-term prevention of asthma in children Allergy 61 2006 855 859
14. E Novembre E Galli F Landi Coseasonal sublingual immunotherapy reduces the development of asthma in children with allergic rhinoconjunctivitis J Allergy Clin Immunol 114 2004 851 857
15. C Moller S Dreborg HA Ferdousi Pollen immunotherapy reduces the development of asthma in children with seasonal rhinoconjunctivitis (the PAT-study) J Allergy Clin Immunol 109 2002 251 256
16. R Polosa WK Al-Delaimy C Russo G Piccillo M Sarva Greater risk of incident asthma cases in adults with allergic rhinitis and effect of allergen immunotherapy: a retrospective cohort study Respir Res 6 2005 153
17. HS Nelson Allergen immunotherapy: where is it now? J Allergy Clin Immunol 119 2007 769 779
18. L Cox JT Li H Nelson R Lockey Allergen immunotherapy: a practice parameter second update J Allergy Clin Immunol 120 2007 S25 S85
19. LS Cox DL Linnemann H Nolte D Weldon I Finegold HS Nelson Sublingual immunotherapy: a comprehensive review J Allergy Clin Immunol 117 2006 1021 1035
20. Z Calamita H Saconato AB Pela AN Atallah Efficacy of sublingual immunotherapy in asthma: systematic review of randomized-clinical trials using the Cochrane Collaboration method Allergy 61 2006 1162 1172
21. G Passalacqua L Guerra F Fumagalli GW Canonica Safety profile of sublingual immunotherapy Treat Respir Med 5 2006 225 234
22. J Bousquet P Demoly Specific immunotherapy: an optimistic future Allergy 61 2006 1155 1158
23. US Food and Drug Administration. Title 21, Part 312 - Investigational New Drug Application [cited June 13, 2007]. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312 .
24. C Lombardi F Gani M Landi Quantitative assessment of the adherence to sublingual immunotherapy J Allergy Clin Immunol 113 2004 1219 1220
25. G Passalacqua A Musarra S Pecora Quantitative assessment of the compliance with a once-daily sublingual immunotherapy regimen in real life (EASY Project: Evaluation of A novel SLIT formulation during a Year) J Allergy Clin Immunol 117 2006 946 948
26. SR Durham WH Yang MR Pedersen N Johansen S Rak Sublingual immunotherapy with once-daily grass allergen tablets: a randomized controlled trial in seasonal allergic rhinoconjunctivitis J Allergy Clin Immunol 117 2006 802 809
27. R Dahl A Kapp G Colombo Efficacy and safety of sublingual immunotherapy with grass allergen tablets for seasonal allergic rhinoconjunctivitis J Allergy Clin Immunol 118 2006 434 440
28. JE Edwards HJ McQuay RA Moore SL Collins Reporting of adverse effects in clinical trials should be improved: lessons from acute postoperative pain J Pain Symptom Manage 18 1999 427 437
29. EC Huskisson JA Wojtulewski Measurement of side effects of drugs BMJ 2 1974 698 699
30. C Caffarelli LG Sensi F Marcucci G Cavagni Preseasonal local allergoid immunotherapy to grass pollen in children: a double-blind, placebo-controlled, randomized trial Allergy 55 2000 1142 1147
31. F Purello-D'Ambrosio S Gangemi S Isola Sublingual immunotherapy: a double-blind, placebo-controlled trial with Parietaria judaica extract standardized in mass units in patients with rhinoconjunctivitis, asthma, or both Allergy 54 1999 968 973
32. F Ippoliti W De Santis A Volterrani Immunomodulation during sublingual therapy in allergic children Pediatr Allergy Immunol 14 2003 216 221
33. T Quirino E Iemoli E Siciliani S Parmiani F Milazzo Sublingual versus injective immunotherapy in grass pollen allergic patients: a double blind (double dummy) study Clin Exp Allergy 26 1996 1253 1261
34. NN Bahceciler U Isik IB Barlan MM Basaran Efficacy of sublingual immunotherapy in children with asthma and rhinitis: a double-blind, placebo-controlled study Pediatr Pulmonol 32 2001 49 55
35. AJ Frew Immunotherapy: how safe is safe? Clin Exp Allergy 36 2006 251 253
36. EH Dunsky MF Goldstein DJ Dvorin GA Belecanech Anaphylaxis to sublingual immunotherapy Allergy 61 2006 1235