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Statement of evidence: Strength of evidence Shekelle et al, BMJ 1999

Statement of evidence: Strength of evidence Shekelle et al, BMJ 1999 directly based on randomised controlled trials and meta-analyses evidence from at least one controlled study without randomisation or extrapolated recommendation from category A evidence

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Statement of evidence: Strength of evidence Shekelle et al, BMJ 1999

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  1. Statement of evidence: Strength of evidence Shekelle et al, BMJ 1999 • directly based on randomised controlled trials and meta-analyses • evidence from at least one controlled study without randomisation or extrapolated recommendation from category A evidence • evidence from at least one other type of quasi- experimental study or extrapolated recommendation from category A or B evidence • evidence from expert committee reports or opinions or clinical experience of respected authorities, ormore than one of these

  2. Effect of nasal inhalation of BDP in mild perennial asthma Watson, Becker & Simons, J Allergy Clin Immunol 1993 - 28 patients (7-17 yr, 10. ± 0.6 yr) - perennial rhinitis + mild asthma - double-blind, placebo-controlled study - intra-nasal BPD: 200 µg, 4 wks - significant improvement in nasal symptoms - no improvement in oral PEFR - significant improvement in PD20FEV1 methacholine (p<0.04) - some improvement in bronchial symptoms

  3. nasal congestion sneezing Effect of nasal and bronchial inhalation of FP in mild seasonal rhinitis and asthma Dahl et al, Allergy 2005 80 80 baseline treatment 60 60 40 40 % patients WITHOUT symptom 20 20 0 0 placebo IHFP placebo IHFP INFP INFP+IHFP INFP INFP+IHFP

  4. Effect of nasal and bronchial inhalation of FP in mild seasonal rhinitis and asthma Dahl et al, Allergy 2005 6 baseline 5 treatment 4 3 PD20 methacholine 2 1 0 placebo INFP IHFP INFP+IHFP

  5. Effect of inhaled budesonide in allergic rhinitis Greiff et al, Eur Respir J 1998 Symptoms Nasal eosinophils 50 3 placebo BUD 40 2 30 nasal eosinophils (%) mean symptom score 20 1 10 0 0 0 2 4 6 8 before during weeks season

  6. Treatment of rhinitis reduces emergency visits for asthma Adams et al, J Allergy Clin Immunol 2002 1,2 • retrospective cohort • study • members of a managed • care organization • aged > 5 years • 13,844 eligible persons • asthma + rhinitis • 1031 (7.4%) had an ED • visit for asthma 1 0,8 ED visit for asthma (OD) 0,6 0,4 0,2 0 H1-blockers ICS 1/yr ICS 3/yr Rhinitis treatment

  7. Strength of evidence 1-Intra-nasal CS have a small and inconsistent effect on bronchial symptoms and BHR : Evidence A 2- Intra-bronchial CS have an unknown effect on nasal symptoms: Evidence B 3- Intra-nasal CS reduce asthma exacerbations: Evidence B

  8. Oral anti-allergic compounds in asthma GINA 2002 H1-histamine antagonists: • High dose of new generation H1-blockers inconstantly found to be effective in asthma • Objective measures of asthma control rarely improved • "Generally not recommended for the treatment of asthma"

  9. Treatment of seasonal allergic airway disease Berger et al, Ann Allergy Asthma Immunol 2002 15 Desloratadine Placebo 10 Instantaneous TSS 5 0 baseline 2 3 4 2-15 2-29 days

  10. Treatment of seasonal allergic airway disease Berger et al, Ann Allergy Asthma Immunol 2002 0,5 Desloratadine 0 Placebo -0,5 -1 AM/PM reflective symptom score change from baseline -1,5 -2 -2,5 -3 total nasal total non "asthma" nasal nasal congestion

  11. Treatment of seasonal asthma with loratadine and pseudoephredine Corren et al, J Allergy Clin Immunol 1997 6 Lora + PseudoE 5 placebo 4 AM asthma severity score 3 2 1 0 0 1 2 3 4 5 6 weeks of treatment

  12. Treatment of seasonal asthma with loratadine and pseudoephredine Corren et al, J Allergy Clin Immunol 1997 0,25 Lora + PseudoE 0,2 placebo 0,15 mean change from baseline 0,1 (liters) 0,05 0 1 -0,05 FEV 1 2 4 6 weeks of treatment

  13. Role of leukotrienes in rhinitis and asthma 1- Release of cyst-LT: - release of cyst-LT in nasal secretions during - early and late phase reaction following allergen challenge - seasonal and perennial allergic rhinitis - release of cyst-LT - in BAL after allergen or ASA challenge - in blood and urine during challenge or asthma exacerbation

  14. Baseline score Baseline score 2.08 1.40 1.65 3.15 Effect of Montelukast in seasonal allergic rhinitis Meltzer et al, J Allergy Clin Immunol 2000 0 placebo -0,25 Loratadine * MNT 10 * -0,5 Lora + MNT ** ** ** Mean evolution ofscore -0,75 -1 * * ** -1,25 combined combined composite QOL score nasal eye score

  15. Montelukast Spring Allergic Rhinitis Daytime Symptoms Scores Malmstrom K et al. J Allergy Clin Immunol 2001: 107(2):S157 0 -0.1 Change from baseline score (LS Mean) -0.2 Placebo Montelukast 10 mg -0.3 Loratadine 10 mg -0.4 P<0.01 vs. Placebo P<0.01 vs. Placebo -0.5 LS = Least Squares. Baseline daytime symptoms score values were 2.09 Montelukast, 2.06 Loratadine, 2.10 Placebo.

  16. Montelukast in Pollen Allergic Rhinitis Rhinitis Symptoms ScoresChervinski et al, Ann Allergy Asthma Immunol 2004 0 MK -0,1 placebo -0,2 change from baseline -0,3 -0,4 -0,5 day time congestion itching sneezing rhinorrhea nasal symptoms

  17. Montelukast in Pollen Allergic Rhinitis Rhinitis Symptoms ScoresChervinski et al, Ann Allergy Asthma Immunol 2004 0 MK -0,05 placebo -0,1 -0,15 change from baseline -0,2 -0,25 -0,3 -0,35 night time nasal cong. difficulty nightime nasal symptoms

  18. Montelukast in Pollen Allergic Rhinitis Rhinitis Symptoms ScoresChervinski et al, Ann Allergy Asthma Immunol 2004 0 MK -0,1 placebo -0,2 change from baseline -0,3 -0,4 -0,5 low medium high pollen counts

  19. Montelukast in Pollen Allergic Rhinitis Rhinitis Symptoms ScoresChervinski et al, Ann Allergy Asthma Immunol 2004 0 MK -0,05 placebo -0,1 -0,15 change from baseline -0,2 -0,25 -0,3 -0,35 day time tearing itchy red puffy eye symptoms

  20. Montelukast in Pollen-induced rhinitis and asthmaPhilip et al, Curr Med Res Opinion 2004 Nasal symptoms 0 placebo -0,1 montelukast -0,2 (0-3 scale) change from baseline -0,3 -0,4 -0,5 day SX night SX

  21. Strength of evidence 1-Intra-nasal CS have a small and inconsistent effect on bronchial symptoms and BHR : Evidence A 2- Intra-bronchial CS have an unknown effect on nasal symptoms: B 3- Intra-nasal CS reduce asthma exacerbations: B 4- LTRAs improve seasonal rhinitis and asthma: A

  22. Allergen immunotherapy for asthma Abramson MJ, Puy RM, Weiner JM, Allergy 1999

  23. Allergen SIT vs placebo increased asthma medications

  24. WHO Position Paper 1997 • The indications of immunotherapy in asthma and rhinitis have been separated in some guidelines[WHO-NHLBI GINA, 1995, International Consensus on Rhinitis, 1994] • this artificial separation has lead to unresolved discussions[Norman, 1996; Barnes, 1996] possibly because the IgE-mediated reaction has not been considered as a multi-organ involvement. • It is therefore important to consider immunotherapy depending on the allergen sensitization rather than depending on the disease itself."

  25. moderate rhinitis ± conjunctivitis severe rhinitis ± conjunctivitis Specific immunotherapy in patients with persitent asthma and rhinitis mild rhinitis allergen avoidance (when possible) pharmacotherapy consider immunotherapy severe persistent asthma moderate persistent asthma intermittent asthma mild persistent asthma pharmacotherapy consider immunotherapy

  26. Immunotherapy with house dust mites in children Warner et al, Lancet 1978 100 p<0.01 p<0.05 NS placebo SIT 75 % patients with improvement 50 25 0 asthma rhinitis eczema

  27. Efficacy of immunotherapy with placebo, allergoids and a standardized allergen extract Bousquet J et al, J Allergy Clin Immunol 1989 35 placebo 30 allergoid 25 HMW-allergoid rush IT with a 20 standardized allergen Days of symptoms 15 10 5 0 rhinitis asthma conjunctivitis

  28. Immunotherapy in Alternaria allergic patients Horst et al, J Allergy Clin Immunol 1990 5 placebo SIT 4 3 mean symptom-medication scoree *** *** 2 1 0 rhinitis asthma

  29. % patients 75 Efficacy of immunotherapy in severe pollinosis Walker et al, J Allergy Clin Immunol 2001 50 SIT 25 placebo 0 worse -25 -50 -75 -100 better total total chest symptoms medications symptoms

  30. Definition of prevention WHO, 2000 • Primary prevention: prevention of the onset of asthma or the immunological sensitization • Secondary prevention: prevention of the development of asthma, e.g. prevention of the development of asthma following sensitization • Tertiary prevention: treatment of asthma (and allergic diseases).

  31. Development of new sensitivities in monosensitized children Des Roches et al, J Allergy Clin Immunol 1997 • case control study • 44 children with HDM allergy • 22 SIT for 3 yrs • 22 matched controls • 3 yr follow up with SPT and • RAST 100 p<0.01 80 60 Percent new sensitizations 40 20 0 SIT control

  32. PAT (Preventive Allergy Treatment) Moller et al, J Allergy Clin Immunol 2002 Aims of the study: To assess whether SIT to pollen in children without asthma may prevent the onset of persistent asthma duration of the trial: 3 yrs Methods: 208 children randomized after 3 yrs: - 94 children in the control group - 97 children under SIT

  33. PAT (Preventive Allergy Treatment) Moller et al, J Allergy Clin Immunol 2002 100 OR=2.52 no asthma 80 asthma 60 % patients 40 20 0 SIT control

  34. Strength of evidence 1-Intra-nasal CS have a small and inconsistent effect on bronchial symptoms and BHR : Evidence A 2- Intra-bronchial CS have an unknown effect on nasal symptoms: B 3- Intra-nasal CS reduce asthma exacerbations: B 4- LTRAs improve seasonal rhinitis and asthma: A 5- SIT is effective in the treatment of rhinitis and asthma induced by pollens and mites: A

  35. 1,5 Omalizumab in moderate-severe allergic asthma AQLQ (Juniper) at 12 weeks Milgrom et al, N Engl J Med 1999 placebo E25 low dose E25 high dose Mean increase in score at 12 wks 1 0,5 0 overall activities asthma emotions environment

  36. 1,5 E25 Efficacy of anti-IgE in birch pollen rhinitis Adelroth et al, J Allergy Clin Immunol 2000 1,25 placebo 1 Average daily nasal symptom score 0,75 0,5 0,25 peak of birch pollen season 0 April 21 May 1 May 7 May 14 May 21 May 28 June 5 June 12

  37. 4 E25 Efficacy of omalizumab in birch pollen rhinitis (RQLQ) Adelroth et al, J Allergy Clin Immunol 2000 placebo 3 RQLQ scores at wks 3-4 2 1 0 total activities sleep non hay practical nasal eye emotions RQLQ fever SX SX SX

  38. Omalizumab improves the control of asthma and rhinitis in the same patients (Wasserfallen score) Ayres et al, Allergy 2004 5 R-placebo R-E25 0 A-placebo A-E25 change from baseline score -5 total-placebo total-E25 -10 -15 baseline 3 6 9 12 time (months)

  39. Strength of evidence 1-Intra-nasal CS have a small and inconsistent effect on bronchial symptoms and BHR : Evidence A 2- Intra-bronchial CS have an unknown effect on nasal symptoms: B 3- Intra-nasal CS reduce asthma exacerbations: B 4- LTRAs improve seasonal rhinitis and asthma: A 5- SIT is effective in the treatment of rhinitis and asthma induced by pollens and mites: A 6- Anti-IgE is effective in the treatment of rhinitis and asthma induced by pollens (rhinitis) and mites: A

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