HATSJOE Study Symptomatic treatment of pollen-related allergic rhinoconjunctivitis in children: a randomized controlled trial.

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Presentation transcript:

HATSJOE Study Symptomatic treatment of pollen-related allergic rhinoconjunctivitis in children: a randomized controlled trial.

Background – Research Questions Allergic rhinitis/rhinoconjunctivitis (AR) ~12% prevalence in children Intranasal corticosteroids (INCS) VS Antihistamines Children (especially <12 years) Oculair symptoms INCS daily VS INCS on demand Physician advise vs patient use

Participants Children aged 6-18 years old From GP medical file: ICPC R97 ATC R01AC, R01AD, R06AA, R06AE, R06AX or S01GX Sensitization to grass pollen (determined by CAP RAST or Skin Prick test, positive test: class ≥2). A minimum retrospective AR symptom score of 7/21 Written informed consent

Intervention Cohort 1: April – June 2013 Cohort 2: April – July 2014 Randomization to: INCS daily (on a daily basis: Fluticasone propionate nasal spray, < 12 years old 100 mcg/day , ≥12 years old 200 mcg/day) INCS on demand (used when needed: Fluticasone propionate, as described in INCS continuous) Antihistamines on demand (used when needed: Levocetirizine dihydrochloride (diHCl) tablet, 5 mg/day)

Outcome measures Primary outcome measure Percentage of symptom free days (4 nose symptoms and 3 eye symptoms, recorded in the daily diary) Secondary outcomes measures 1) mean daily allergy symptom score 2) mean eye symptom score 3) mean nose symptom score 4) mean daily allergy symptom score per symptom (total of 7) 5) percentage of symptom free days for each symptom separately 6) proportion of rescue medication-free days and use of rescue medication 7) disease-specific quality of life 8) patient preference of medication over the total period of three months

Table 1. Baseline Characteristics INCS Continuous (n=50) INCS on demand (n=52) Antihistamines (n=48) Boys N(%) 22 (44) 30 (57.7) 26 (54.2) Age (y) Mean (SD) 12.1 (3.3) 11.8 (3.1) 11.0 Retrospective symptom score1 Total [mean (SD)]2 4.6 (3.2) 5.2 (2.6) 5.4 (3.6) Nose [mean (SD)]3 2.2 (2.3) 2.1 (2.2) 2.9 Eye [mean (SD)]4 2.4 (2.7) 3.1 (2.0) (2.5) Asthma N(%) 8 (17.4) 5 (9.8) Grass sensitization class >2 N(%) 31 (62) 36 (69.2) (62.5) Birch pollen sensitization N(%) (60) (59.6) 28 (58.3) HDM sensitization N(%) 25 (50) (53.8) 24 Current use of secondary care for AR5 N(%) 6 (12.5) 4 (7.8) (8.7) Cohort 1 N(%) 18 (36) 16 (30.8) 17 (35.4) Participants with evaluable days, ITT population N(%) 45 (90) 41 (88.5) 46 (85.4) 1 (n=12 missing) 2 (scale 0-21)3 (scale 0-12)4(scale 0-9) 5(n=5 missing)

Medication use Antihistamine: 43 tablets (on average for 91 days) INCS daily: 90% of the days (SD 16) 23.1 ml fluticasone (± 257 sprays) INCS on demand: 30% of the days (SD 21) 9.1 ml fluticasone (± 102 sprays)

Results % Symptom free days INCS daily: 22% INCS on demand : 30% Antihistamines: 15% Clinically relevant difference set at 10%-point in symptom free days INCS on the demand vs INCS daily 8% in favour of INCS on demand (95%CI: -5 to +21%) (due to significantly better score on eye symptoms) INCS daily vs Antihistamine 7% in favour of INCS daily (95%CI: -6% to +19%)

Conclusions INCS daily is not superior to INCS on demand Antihistamines are not superior to INCS daily On demand use of INCS leads to 61% less corticosteroid use

Questions?

Flowchart

Measurements Daily online diary PRQLQ/AdolRQLQ (Juniper et al.1,2) Patient preference questionnaire 1 Juniper E, Howland W, Roberts N, Thompson A, King D. Measuring quality of life in children with rhinoconjunctivitis. . J Allergy Clin Immunol 1998; 101: 163-70. 2 Juniper E, Guyatt G, Dolovich J. Assessment of quality of life in adolescents with allergic rhinoconjunctivitis: development and testing of a questionnaire for clinical trials. J Allergy Clin Immunol 1994; 93: 413-23.

Statistics Two comparisons: INCS daily vs INCS on demand INCS daily vs antihistamines on demand Treatment effects will be tested 2-sided with a significance level of 2,5% using an ANCOVA. Covariates Age Gender Grass sensitization class Birch pollen sensitization HDM sensitization Cohort Baseline symptom sum score at entry into study Current use of secondary care for their AR

INCS D vs Antihistamine Table 2. Results of the univariate analyses of the symptom free days (intention-to-treat in pollenseason) INCS daily INCS on demand INCS D vs INCS OD Antihistamine INCS D vs Antihistamine mean (95% CI) P-value P-Value Percentage symptom free days 22 (14-30) 30 (22-38) 0,062 15 ( 9 - 21) 0,815 Percentage well days 52 (43-62) 60 (51-69) 0,1 46 (38-54) 0,72 Percentage nose symptom free days total 31 (21-40) 36 (27-45) 0,431 19 (12 - 27) 0,151,3,7 sneezing 57 (47-67) 54 (44-64) 0,915 38 (29-47) 0,0171,2,3,6,7 nose blockage 62 (52-73) 58 (49-68) 0,932 50 (41-60) 0,359 runny nose 67 (58-76) 72 (65-79) 0,134 51 (43-60) 0,0711,3,7 itching nose 49 (40-59) 59 (49-69) 0,192 41 (32-49) 0,356 Percentage eye symptom free days 40 (31-50) 56 (47-65) 0,0051,2,4,6 0,0717 itching eyes 43 (33-53) 61 (52-69) 0,0021,2,3,4,6,7 52 (44-60) 0,0224,5,6 redness 71 (62-81) 80 (74-87) 0,0222,6 78 (70-86) 0,0544,5,6 tearing 68 (59-77) 73 (64-81) 0,165 70 (62-77) 0,382 P<0.05 in Other scenario’s: 1 Pollen season Per Protocol(PP); 2 Grass season Intention to Treat (I.T.T.); 3 Grass season P.P.; 4 Birch season I.T.T.; 5 Birch season P.P.; 6 All days I.T.T.; 7 All days P.P.

INCS D vs Antihistamine Table 3. Symptomscores Table 3. Diary allergic symptomscores, per randomization group INCS daily INCS on demand INCS D vs INCS OD Antihistamine INCS D vs Antihistamine Mean (95% CI) P-value Mean Daily Symptom Score (Range 0-21) 3,90 (3,03 - 4,7) 3,26 (2,51 - 4,01) 0,840 4,63 (3,81 – 5,4) 0,640 Mean Nose Symptom Score (Range 0-12) 2,20 (1,69 - 2,71) 2,08 (1,63 - 2,54) 0,416 3,14 (2,62 – 3,65) 0,0501,2,3,6,7 Mean Eye Symptom Score (Range 0-9) 1,69 (1,28 - 2,11) 1,18 (0,84 - 1,52) 0,0092,6 1,50 (1,09 – 1,90) 0,1174,5 P<0.05 in Other scenario’s: 1 Pollen season Per Protocol(PP); 2 Grass season Intention to Treat (I.T.T.); 3 Grass season P.P.; 4 Birch season I.T.T.; 5 Birch season P.P.; 6 All days I.T.T.; 7 All days P.P.