Double-blind, placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device

Hampel, Frank C.; Ratner, Paul H.; Bavel, Julius van; Amar, Niran J.; Daftary, Pramila; Wheeler, William J.; Sacks, H.

doi:10.1016/j.anai.2010.06.008

Cited by 136 publications

(135 citation statements)

References 19 publications

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“…MP29-02, a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP), has previously been shown to be more effective than INS [22,23]. We have taken the first of these studies, which compared MP29-02 to commercially available active comparators (i.e.…”

Section: Background and Objectivesmentioning

confidence: 99%

“…and others), without having access to the data. The methods of the study have been previously published [22] and are presented in the online supplementary material (for all online supplementary material, see www.karger.com/doi/10.1159/000351404).…”

Section: Background and Objectivesmentioning

confidence: 99%

“…We have taken the first of these studies, which compared MP29-02 to commercially available active comparators (i.e. Astelin® and generic Flonase®) [22] to assess the data in a more clinically relevant way using several new analyses. Many of these analyses had not previously been developed at the time of study protocol submission and so were introduced post hoc.…”

Section: Background and Objectivesmentioning

confidence: 99%

“…This is a post hoc analysis of a phase III, multicenter, randomized, double-blind, parallel group trial [MP4001 (NCT00660517)] [22]. The aim was to firstly introduce new and more clinically meaningful efficacy analyses to gauge the efficacy of AR therapies, and secondly to assess the efficacy of MP29-02 and currently available first-line AR therapies using these new analyses.…”

Section: Background and Objectivesmentioning

confidence: 99%

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Clinically Relevant Effect of a New Intranasal Therapy (MP29-02) in Allergic Rhinitis Assessed by Responder Analysis

Meltzer

Ratner

Bachert

et al. 2013

Int Arch Allergy Immunol

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105

137

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Background: It is unclear what constitutes a clinically meaningful response for allergic rhinitis (AR) outcomes. The objectives of these post hoc analyses were (1) to define a clinically meaningful response using novel efficacy analyses (including a responder analysis), and (2) to compare the efficacy of MP29-02 [a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP)] with commercially available FP, AZE and placebo in seasonal AR (SAR) patients, using these novel analyses. Methods: 610 moderate-to-severe SAR patients (≥12 years old) were randomized into a double-blind, placebo-controlled, 14-day, parallel-group trial. Change from baseline in the reflective total nasal symptom score (rTNSS) over 14 days was the primary outcome. Post hoc endpoints included the sum of nasal and ocular symptoms (rT7SS), efficacy by disease severity and by predominant nasal symptom, and a set of responder analyses. Results: MP29-02 most effectively reduced rT7SS (relative greater improvement: 52% to FP; 56% to AZE) and both nasal and ocular symptoms irrespective of severity. More MP29-02 patients achieved a ≥30, ≥50, ≥60, ≥75 and ≥90% rTNSS reduction, which occurred days faster than with either active comparator; MP29-02 alone was superior to placebo at the ≥60% (or higher) threshold. One in 2 MP29-02 patients achieved a ≥50% rTNSS reduction and 1 in 6 achieved complete/near-to-complete response. Only MP29-02 was consistently superior to placebo for all patients, whatever their predominant symptom. Conclusions: MP29-02 provided faster and more complete symptom control than first-line therapies. It was consistently superior irrespective of severity, response criteria or patient-type, and may be considered the drug of choice for moderate-to-severe AR. These measures define a new standard for assessing relevance in AR.

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Section: Background and Objectivesmentioning

confidence: 99%

Section: Background and Objectivesmentioning

confidence: 99%

Section: Background and Objectivesmentioning

confidence: 99%

Section: Background and Objectivesmentioning

confidence: 99%

See 2 more Smart Citations

Clinically Relevant Effect of a New Intranasal Therapy (MP29-02) in Allergic Rhinitis Assessed by Responder Analysis

Meltzer

Ratner

Bachert

et al. 2013

Int Arch Allergy Immunol

Self Cite

105

137

View full text Add to dashboard Cite

show abstract

“…Although they did not perform new clinical trials, they were able to test, based upon predefined criteria of success, the a priori hypothesis of a more relevant clinical effect of the new therapeutic entity against placebo. They re-analyzed a patient population suffering from severe rhinitis, which also included a SCUAD population [8]. Their responder sensitivity analyses are innovative, yet necessary, owing to the fact that EMA (European Medicines Agency) as regulatory body questions the clinical relevance of a simple change from baseline in the total nasal symptom score.…”

mentioning

confidence: 99%