Mometasone furoate in the treatment of mild, moderate, or severe persistent allergic rhinitis: a non-inferiority study (PUMA)

Martti Anton Antila, Fabio Morato Castro, Flavio Sano, Adelmir Machado, Fatima Fernandes, Nelson Augusto Rosário Filho, Rafael Stelmach, Martti Anton Antila, Fabio Morato Castro, Flavio Sano, Adelmir Machado, Fatima Fernandes, Nelson Augusto Rosário Filho, Rafael Stelmach

Abstract

Introduction: Allergic rhinitis is considered the most prevalent respiratory disease in Brazil and worldwide, with great impact on quality of life, affecting social life, sleep, and also performance at school and at work.

Objective: To compare the efficacy and safety of two formulations containing mometasone furoate in the treatment of mild, moderate, or severe persistent allergic rhinitis after four weeks of treatment.

Methods: Phase III, randomized, non-inferiority, national, open study comparing mometasone furoate in two presentations (control drug and investigational drug). The primary endpoint was the percentage of patients with reduction of at least 0.55 in nasal index score (NIS) after four weeks of treatment. Secondary outcomes included total nasal index score score after four and 12 weeks of treatment; individual scores for symptoms of nasal obstruction, rhinorrhea, sneezing, and nasal pruritus; as well as score for pruritus, lacrimation, and ocular redness after four and 12 weeks of treatment. The study was registered at clinicaltrials.gov with the reference number NCT01372865.

Results: The efficacy primary analysis demonstrated non-inferiority of the investigational drug in relation to the control drug, since the upper limit of the confidence interval (CI) of 95% for the difference between the success rates after four weeks of treatment (12.6%) was below the non-inferiority margin provided during the determination of the sample size (13.7%). Adverse events were infrequent and with mild intensity in most cases.

Conclusion: The efficacy and safety of investigational drug in the treatment of persistent allergic rhinitis were similar to the reference product, demonstrating its non-inferiority.

Keywords: Furoato de mometasona; Mometasone furoate; Non-inferiority; Não inferioridade; Persistent allergic rhinitis; Rinite alérgica persistente.

Copyright © 2016 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

Figures

Figure 1
Figure 1
Flow of patients in the study (ITT, intent to treat population; PP, per-protocol population; RV, randomization visit).
Figure 2
Figure 2
Symptom score.
Figure 3
Figure 3
Primary analysis of efficacy in the PP population (n = 346).
Figure 4
Figure 4
Total NIS score over time based on patient diary, PP population (n = 308).

References

    1. Bousquet J., Khaltaev N., Cruz A.A., Denburg J., Fokkens W.J., Toqias A., et al. Allergic rhinitis and its impact on asthma (ARIA) 2008 update. Allergy. 2008;(Suppl. 86):8–160.
    1. Plaut M., Valentine M.D. Clinical practice: allergic rhinitis. N Engl J Med. 2005;353:1934–1944.
    1. Ibiapina Cda.C., Sarinho E.S., Camargos P.A., Andrade C.R., Cruz Filho A.A. Allergic rhinitis: epidemiological aspects, diagnosis and treatment. J Bras Pneumol. 2008;34:230–240.
    1. Dykewicz M.S., Fineman S. Executive summary of joint task force practice parameters on diagnosis and management of rhinitis. Ann Allergy Asthma Immunol. 1998;81:463–468.
    1. Lima R.G., Pastorino A.C., Casagrande R.R., Sole D., Leone C., Jacob C.M. Prevalence of asthma, rhinitis and eczema in 6–7 years old students from the western districts of São Paulo city, using the standardized questionnaire of the “International Study of Asthma and Allergies in Childhood” (ISAAC)-phase IIIB. Clinics. 2007;62:225–234.
    1. III Consenso brasileiro sobre rinites. Braz J Otorhinolaringol. 2012;75:6–51.
    1. Kay A.B. Allergy and allergic diseases: second of two parts. N Engl J Med. 2001;344:109–113.
    1. Brozek J.L., Bousquet J., Baena-Cagnani C.E., Bonini S., Canonica G.W., Casale T.B., et al. Allergic rhinitis and its impact on ashtma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol. 2010;126:466–476.
    1. Bousquet J., Reid J., van Weel C., Baena Cagnani C., Canonica G.W., Demoly P., et al. Allergic rhinitis management pocket reference 2008. Allergy. 2008;63:990–996.
    1. Weiner J.M., Abramson M.J., Puy R.M. Intranasal corticosteroids versus oral H1 receptor antagonists in allergic rhinitis: systematic review of randomised controlled trials. BMJ. 1998;317:1624–1629.
    1. Yanez A., Rodrigo G.J. Intranasal corticosteroids versus topical H1 receptor antagonists for the treatment of allergic rhinitis: a systematic review with meta-analysis. Ann Allergy Asthma Immunol. 2002;89:479–484.
    1. Taramarcaz P., Gibson P.G. Intranasal corticosteroids for asthma control in people with coexisting asthma and rhinitis. Cochrane Database Syst Rev. 2003;4:CD003570.
    1. Penagos M., Compalati E., Tarantini F., Baena-Cagnani C.E., Passalacqua G., Canonica G.W. Efficacy of mometasone furoate nasal spray in the treatment of allergic rhinitis: meta-analysis of randomized, double-blind, placebo-controlled, clinical trials. Allergy. 2008;63:1280–1291.
    1. Baldwin C.M., Scott L.J. Mometasone furoate: a review of its intranasal use in allergic rhinitis. Drugs. 2008;68:1723–1739.
    1. Barnes M.L., Vaidyanathan S., Williamson P.A., Lipworth B.J. The minimal clinically important difference in allergic rhinitis. Clin Exp Allergy. 2010;40:242–250.
    1. Munk Z.M., Gross G.N., Hampel F.C., Jr., Ratner P.H. Preseasonal, once daily triamcinolone acetonide nasal aerosol for seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 1997;78:325–331.
    1. Meltzer E.O. Clinical and antiinflammatory effects of intranasal budesonide aqueous pump spray in the treatment of perennial allergic rhinitis. Ann Allergy Asthma Immunol. 1998;81:128–134.
    1. Creticos P., Fireman P., Settipane G., Bernstein D., Casale T., Schwartz H., Rhinocort Aqua Study Group Intranasal budesonide aqueous pump spray (Rhinocort Aqua) for the treatment of seasonal allergic rhinitis. Allergy Asthma Proc. 1998;19:285–294.
    1. Bende M., Carrillo T., Vona I., da Castel-Branco M.G., Arheden L. A randomized comparison of the effects of budesonide and mometasone furoate aqueous nasal sprays on nasal peak flow rate and symptoms in perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2002;88:617–623.
    1. Baraniuk J.N. Subjective nasal fullness and objective congestion. Proc Am Thorac Soc. 2011;8:62–69.
    1. Derendorf H., Meltzer E.O. Molecular and clinical pharmacology of intranasal corticosteroids: clinical and therapeutic implications. Allergy. 2008;63:1292–1300.
    1. Petty D.A., Blaiss M.S. Intranasal corticosteroids topical characteristics: side effects, formulation, and volume. Am J Rhinol Allergy. 2013;27:510–513.
    1. Chong Neto H.J., Rosario N.A., Westphal G.L.C., Riedi C.A., Santos H.L.B.S. Allergic conjunctivitis in asthmatic children: as common as underreported. Ann Allergy Asthma Immunol. 2010;105:399–400.
    1. Lightman S., Scadding G.K. Should intranasal corticosteroids be used for the treatment of ocular symptoms of allergic rhinoconjunctivitis? A review of their efficacy and safety profile. Int Arch Allergy Immunol. 2012;158:317–325.
    1. Hochhaus G. Pharmacokinetic/pharmacodynamic profile of mometasone furoate nasal spray: potential effects on clinical safety and efficacy. Clin Ther. 2008;30:1–13.
    1. Minshall E., Ghaffar O., Cameron L., O’Brien F., Quinn H., Rowe-Jones J., et al. Assessment by nasal biopsy of long-term use of mometasone furoate aqueous nasal spray (Nasonex) in the treatment of perennial rhinitis. Otolaryngol Head Neck Surg. 1998;118:648–654.
    1. 2010. Allergies in Latin America: a landmark survey of nasal allergy sufferers. Available from: [October 2013]
    1. Meltzer E.O., Blaiss M.S., Derebery M.J., Mahr T.A., Gordon B.R., Sheth K.K., et al. Burden of allergic rhinitis: results from the pediatric allergies in America survey. J Allergy Clin Immunol. 2009;124(Suppl 3):S43–S70.
    1. Blaiss M.S., Allergic Rhinitis in Schoolchildren Consensus Group Allergic rhinitis and impairment issues in schoolchildren: a consensus report. Curr Med Res Opin. 2004;20:1937–1952.
    1. Lavie P., Gertner R., Zomer J., Podoshin L. Breathing disorders in sleep associated with “microarousals” in patients with allergic rhinitis. Acata Otolaryngol. 1981;92:529–533.
    1. Craig T.J., Teets S., Lehman E.B., Chinchilli V.M., Zwillich C. Nasal congestion secondary to allergic rhinitis as a cause of sleep disturbance and daytime fatigue and the response to topical nasal corticosteroids. J Allergy Clin Immunol. 1998;101:633–637.

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit