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

Detalhes bibliográficos
Autor(a) principal: Antila,Martti Anton
Data de Publicação: 2016
Outros Autores: Castro,Fabio Morato, Sano,Flavio, Machado,Adelmir, Fernandes,Fatima, Rosário Filho,Nelson Augusto, Stelmach,Rafael
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Brazilian Journal of Otorhinolaryngology
Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1808-86942016000500580
Resumo: 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.
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spelling Mometasone furoate in the treatment of mild, moderate, or severe persistent allergic rhinitis: a non-inferiority study (PUMA)Persistent allergic rhinitisMometasone furoateNon-inferiorityABSTRACT 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.Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial.2016-10-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S1808-86942016000500580Brazilian Journal of Otorhinolaryngology v.82 n.5 2016reponame:Brazilian Journal of Otorhinolaryngologyinstname:Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial (ABORL-CCF)instacron:ABORL-CCF10.1016/j.bjorl.2015.11.009info:eu-repo/semantics/openAccessAntila,Martti AntonCastro,Fabio MoratoSano,FlavioMachado,AdelmirFernandes,FatimaRosário Filho,Nelson AugustoStelmach,Rafaeleng2016-11-09T00:00:00Zoai:scielo:S1808-86942016000500580Revistahttp://www.bjorl.org.br/https://old.scielo.br/oai/scielo-oai.phprevista@aborlccf.org.br||revista@aborlccf.org.br1808-86861808-8686opendoar:2016-11-09T00:00Brazilian Journal of Otorhinolaryngology - Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial (ABORL-CCF)false
dc.title.none.fl_str_mv Mometasone furoate in the treatment of mild, moderate, or severe persistent allergic rhinitis: a non-inferiority study (PUMA)
title Mometasone furoate in the treatment of mild, moderate, or severe persistent allergic rhinitis: a non-inferiority study (PUMA)
spellingShingle Mometasone furoate in the treatment of mild, moderate, or severe persistent allergic rhinitis: a non-inferiority study (PUMA)
Antila,Martti Anton
Persistent allergic rhinitis
Mometasone furoate
Non-inferiority
title_short Mometasone furoate in the treatment of mild, moderate, or severe persistent allergic rhinitis: a non-inferiority study (PUMA)
title_full Mometasone furoate in the treatment of mild, moderate, or severe persistent allergic rhinitis: a non-inferiority study (PUMA)
title_fullStr Mometasone furoate in the treatment of mild, moderate, or severe persistent allergic rhinitis: a non-inferiority study (PUMA)
title_full_unstemmed Mometasone furoate in the treatment of mild, moderate, or severe persistent allergic rhinitis: a non-inferiority study (PUMA)
title_sort Mometasone furoate in the treatment of mild, moderate, or severe persistent allergic rhinitis: a non-inferiority study (PUMA)
author Antila,Martti Anton
author_facet Antila,Martti Anton
Castro,Fabio Morato
Sano,Flavio
Machado,Adelmir
Fernandes,Fatima
Rosário Filho,Nelson Augusto
Stelmach,Rafael
author_role author
author2 Castro,Fabio Morato
Sano,Flavio
Machado,Adelmir
Fernandes,Fatima
Rosário Filho,Nelson Augusto
Stelmach,Rafael
author2_role author
author
author
author
author
author
dc.contributor.author.fl_str_mv Antila,Martti Anton
Castro,Fabio Morato
Sano,Flavio
Machado,Adelmir
Fernandes,Fatima
Rosário Filho,Nelson Augusto
Stelmach,Rafael
dc.subject.por.fl_str_mv Persistent allergic rhinitis
Mometasone furoate
Non-inferiority
topic Persistent allergic rhinitis
Mometasone furoate
Non-inferiority
description 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.
publishDate 2016
dc.date.none.fl_str_mv 2016-10-01
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format article
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dc.identifier.uri.fl_str_mv http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1808-86942016000500580
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dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 10.1016/j.bjorl.2015.11.009
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
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dc.format.none.fl_str_mv text/html
dc.publisher.none.fl_str_mv Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial.
publisher.none.fl_str_mv Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial.
dc.source.none.fl_str_mv Brazilian Journal of Otorhinolaryngology v.82 n.5 2016
reponame:Brazilian Journal of Otorhinolaryngology
instname:Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial (ABORL-CCF)
instacron:ABORL-CCF
instname_str Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial (ABORL-CCF)
instacron_str ABORL-CCF
institution ABORL-CCF
reponame_str Brazilian Journal of Otorhinolaryngology
collection Brazilian Journal of Otorhinolaryngology
repository.name.fl_str_mv Brazilian Journal of Otorhinolaryngology - Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial (ABORL-CCF)
repository.mail.fl_str_mv revista@aborlccf.org.br||revista@aborlccf.org.br
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