Table 1.

Overview of key selected studies with Oralair®.

	Population (n)a	Summary
Phase I–III
VO56.07A (NCT00619827) Horak et al.43	Adults (18–50 y) with moderate-severe ARC (n=45)	Phase I: Demonstrated rapid onset of action of the 300 IR dose with reductions in symptom scores seen as early as week 1.
VO34.04 (NCT00367640). Didier et al.28	Adults (18–45 y) with moderate-severe ARC ± mild asthma (n=472)	Phase IIb/III: Pivotal dose-ranging study in Europe. Demonstrated efficacy of the 300 IR dose in reducing ARC symptoms and use of rescue medications for symptomatic relief. Favorable safety and tolerability. Outcomes were consistent, regardless of sensitization status or presence of comorbid asthma.
VO52.06 (NCT00409409) Wahn et al.44	Children (5–17 y) with moderate-severe ARC ± mild asthma (n=139)	Phase III: Pivotal European pediatric study, which demonstrated efficacy in reducing ARC symptoms and use of rescue medications with good safety and tolerability profile. Outcomes were consistent, regardless of sensitization or asthma status.
VO61.08 (NCT00955825) Cox et al.45	Adults (18–65 y) with moderate-severe ARC ± mild asthma (n=133)	Phase III: Pivotal US study. Demonstrated efficacy of the 300 IR dose in reducing daily symptoms and medication use. Favorable safety and tolerability. Outcomes were consistent, regardless of sensitization status or presence of comorbid asthma.
VO53.06 (NCT00418379) Didier et al.46–48	Adults (18–50 y) with moderate-severe ARC ± mild asthma (n=414)	Phase III: Demonstrated benefit of 300IR dose when given across 3 consecutive seasons, with sustained efficacy seen for up to 2 y after treatment cessation. Outcomes were consistent, regardless of sensitization or asthma status.
Post-licensure studies
Post-approval safety studies (PASS) Pfaar et al.; Eberle et al.; Gerstlauer et al.49–51	Children and adults (5–65 y) with moderate-severe ARC ± mild asthma (n=1,911)	Confirmed safety of the 300 IR dose. Most ADRs were local, associated with sublingual administration in early treatment phase. Treatment discontinuation due to ADRs ranged from 5–9%. No anaphylaxis events were reported.
French 1-y, prospective, open-label, observational study Blin et al.52	Children and adults (>5 y) with moderate-severe ARC ± mild asthma (n=483)	Reduction in frequency and severity of symptom in children and adults.
German 2-y, prospective, open-label, observational study Shah-Hosseini et al.53,54	Children and adults (4–75 y) with moderate-severe ARC ± mild asthma (n=1,482)	Demonstrated sustained efficacy over 2 consecutive years of treatment, with reduction in symptom scores compared with pre-treatment scores and reduction in symptomatic medication use in both children and adult patients.
Spanish 2-y, prospective, open-label, observational study Antolin-Amerigo et al.55	Children and adults (≥6 y) with moderate-severe ARC ± mild asthma (n=591)	Reduction in frequency and severity of symptoms; reduction in medication use; high rate of treatment satisfaction.
German 1-y prospective, open-label, observational study Schafer et al.56	Adults (≥18 y) with moderate-severe ARC ± mild asthma (n=327)	Significant improvements in ARC symptoms and reduction in medication use; improved QoL and treatment satisfaction.
Netherlands prospective, open-label, observational study over 1 season Ras et al.57	Children and adults (≥5 years) with moderate-severe ARC ± mild asthma (n=196)	Reduction in frequency and severity of ARC symptoms; high persistence with treatment (70%) and intention to continue the following season (80%).
Italian prospective, open-label, observational study over 1 season Pastorello et al.58	Children and adults (12–45 y) with mild/moderate-severe ARC ± mild asthma (n=47)	Reduction in symptom severity and medication use.
German 1-y prospective, open-label, observational study Klein et al.59	Children and adults (≥5 y) with moderate-severe ARC ± mild asthma (n=883)	90% of subjects (children, adolescents and adults) reported benefit (as measured using the ‘Patient Benefit Index—Allergic Rhinitis (PBI-AR) score’. Benefits were similar in mono- and polyallergic children but higher in polyallergic adolescents and adults.
Longitudinal claims database studies (France/Germany) Devillier et al.; Zielen et al.60,61	Adults with moderate-severe ARC ± mild asthma (n=3,950)b	Demonstrated reduction in symptomatic medication use in patients receiving SLIT over 2 y (Oralair® or Grazax™) compared to controls; benefit was evident for up to 6 y after cessation of SLIT. Use of SLIT was associated with a reduction in prescriptions for new asthma cases, and if asthma did develop, onset was later with SLIT compared with controls; patients with asthma also required fewer asthma medications following SLIT treatment.

n = number of subjects receiving Oralair®.

n = number of subjects receiving Oralair® or Grazax™.