A novel intranasal therapy of azelastine with fluticasone for the treatment of allergic rhinitis Warner Carr, MD, Jonathan Bernstein, MD, Phil Lieberman,

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A novel intranasal therapy of azelastine with fluticasone for the treatment of allergic rhinitis Warner Carr, MD, Jonathan Bernstein, MD, Phil Lieberman, MD, Eli Meltzer, MD, Claus Bachert, MD, PhD, David Price, MD, Ullrich Munzel, PD Dr rer nat, Jean Bousquet, MD, PhD Journal of Allergy and Clinical Immunology Volume 129, Issue 5, Pages 1282-1289.e10 (May 2012) DOI: 10.1016/j.jaci.2012.01.077 Copyright © 2012 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 1 Effect of MP29-02, FP (FLU), and azelastine (AZE) on overall rTNSSs (morning plus evening) in patients with moderate-to-severe SAR. Data are presented as least squares (LS) mean change from baseline derived by means of ANCOVA minus placebo. The precision of these estimates are indicated by the upper bounds of the respective 95% CIs. Study MP4002: n = 831, ∗P = .034 versus FP; †P = .001 versus AZE; Study MP4004: n = 776, ∗P = .038 versus FP; †P = .032 versus AZE; Study MP4006: n = 1791, ∗P = .029 versus FP; †P = .016 versus AZE; Meta-analysis: n = 3398, ∗P < .001 versus FP; †P < .001 versus AZE. Journal of Allergy and Clinical Immunology 2012 129, 1282-1289.e10DOI: (10.1016/j.jaci.2012.01.077) Copyright © 2012 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 Time-response curves showing the percentage of patients exhibiting 50% improvement in rTNSSs (A) or a score of 1 point or less (ie, complete or near-complete resolution) for each nasal symptom (B) by treatment day after treatment with MP29-02 (n = 834), FP (FLU; n = 846), azelastine (AZE; n = 847), or placebo (PLA; n = 857). Data are presented as mean proportion of patients for the meta-analysis dataset (studies MP4002, MP4004, and MP4006). Fig 2, A, MP29-02 versus FLU: P = .071; MP29-02 versus AZE: P < .001; MP29-02 versus PLA: P < .001. Fig 2, B, MP29-02 versus FLU: P = .033; MP29-02 versus AZE: P < .001; MP29-02 versus PLA: P < .001. Journal of Allergy and Clinical Immunology 2012 129, 1282-1289.e10DOI: (10.1016/j.jaci.2012.01.077) Copyright © 2012 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 3 Effect of MP29-02, FP (FLU), azelastine (AZE), and placebo (PLA) on rTNSSs (morning plus evening) by severity in patients with SAR. Patients were classified as having more or less severe disease based on median baseline rTNSSs or baseline RQLQ scores (ie, baseline rTNSS score ≤18.9 [MP29-02: n = 425; FP: n = 407; AZE: n = 417; PLA: n = 407] or >18.9 [MP29-02: n = 423; FP: n = 438; AZE: n = 427; PLA: n = 449] or baseline RQLQ score ≤3.9 [MP29-02: n = 374; FP: n = 382; AZE: n = 382; PLA: n = 364] or >3.9 [MP29-02: n = 363; FP: n = 356; AZE: n = 365; PLA: n = 373]). Data are presented as least squares (LS) mean change from baseline for the meta-analysis dataset (studies MP4002, MP4004, and MP4006). The precision of these estimates are indicated by the lower bounds of the respective 95% CIs. ∗P ≤ .001 versus all active treatments. †P < .040 versus MP29-02. ‡P < .010 versus MP29-02. Journal of Allergy and Clinical Immunology 2012 129, 1282-1289.e10DOI: (10.1016/j.jaci.2012.01.077) Copyright © 2012 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E1 Effect of MP29-02 (n = 848), FP (FLU; n = 846), azelastine (AZE; n = 847), and placebo (PLA; n = 857) on rTNSSs (morning plus evening) on each day of the treatment period in patients with moderate-to-severe SAR. Data are presented as least squares (LS) mean change from baseline ± SE for the meta-analysis dataset (studies MP4002, MP4004, MP4006). ∗P < .001 versus all active treatments. †P ≤ .015 versus MP29-02. ‡P ≤ .050 versus MP29-02. Mean baseline values (SDs): MP29-02, 18.8 (2.86); FP, 18.9 (2.78); AZE, 18.9 (3.00); PLA, 19.0 (2.80). Journal of Allergy and Clinical Immunology 2012 129, 1282-1289.e10DOI: (10.1016/j.jaci.2012.01.077) Copyright © 2012 American Academy of Allergy, Asthma & Immunology Terms and Conditions