Changes in Symptom and Quality of Life in Patients With Uncontrolled Asthma Treated With Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) (BENTEN)
BENTEN Study: Changes in Symptom and Quality of Life in Patients With Uncontrolled Asthma Treated With Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI): a Prospective, Multi-centers, Observational Study
This is a single arm, prospective non-interventional study with primary data collection in patients initiated BGF MDI treatment as part of routine clinical care. In this study, 200 patients will be enrolled from approximately 20 sites mainly in general hospitals with respiratory/allergy/asthma specialists in Japan.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Yoichi Tamai
- Número de telefone: 070-2453-4913
- E-mail: yoichi.tamai@astrazeneca.com
Estude backup de contato
- Nome: Hitomi Uchimura
- Número de telefone: 06-4802-3600
- E-mail: hitomi.uchimura@astrazeneca.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
The study population will be composed of 200 patients with asthma who are newly initiated BGF MDI treatment and who can regularly visit the study site in Japan.
Descrição
Inclusion Criteria:
- Patients aged >=18 years at enrollment
- Patients diagnosed with asthma with an ACQ -5 score ≥1.5 at enrollment
- Patients who are judged to newly initiate BGF MDI (320/28.8/9.6 ug) treatment as per the investigator's decision and are able to initiate inhalation on the same day as the prescription or, if they have already used another inhaled medication on that day, on the following day.
- Patients who are capable to fill PRO physically and mentally as judged by investigator
- Patients who are assessed as able to visit the study site during the 8-week follow-up period
- Patients who provide written informed consent
Exclusion Criteria:
- Patients who have been treated with ICS/LABA/LAMA within 6 months before enrollment
- Patients who have participated in any interventional studies within 1 year before enrollment
- Patients who have history of asthma exacerbation within 4 weeks before enrollment
- Patients who have history of respiratory infection within 4 weeks before enrollment
- Patients who are prescribed systemic corticosteroids within 4 weeks before enrollment
- Patients who have been treated with any biologic therapy for asthma (e.g., anti-IgE, anti-IL-5/IL-5R, anti-IL-4R, anti-TSLP) within 1 year before enrollment
- Patients who are pregnant, lactating or intending to become pregnant during the study period
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Patients with asthma newly initiated on BGF MDI
The study population will include approximately 200 adult patients with asthma in Japan who are newly initiated BGF MDI treatment, have an ACQ-5 score ≥1.5 at enrollment. |
Initiation of BGF MDI treatment in routine clinical practice.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from baseline in Asthma Control Questionnaire-5 (ACQ-5) score
Prazo: at Week 8
|
To evaluate the change in asthma control at 8 weeks from baseline in patients with asthma initiated on BGF MDI, as measured by ACQ-5. |
at Week 8
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in asthma control measured by ACQ-5 at 8 weeks from baseline in the asthma patients initiated with BGF MDI, separately in patients with and without prior inhaled maintenance treatment
Prazo: at week 8 from baseline
|
To evaluate changes in asthma control measured by ACQ-5 at 8 weeks from baseline in the asthma patients initiated with BGF MDI, separately in patients with and without prior inhaled maintenance treatment (defined in 3.5) |
at week 8 from baseline
|
|
Changes in asthma control measured by ACQ-5
Prazo: at week 2 and 4 from baseline
|
To evaluate changes in asthma control measured by ACQ-5 at 2 and 4 weeks from baseline in the asthma patients initiated with BGF MDI |
at week 2 and 4 from baseline
|
|
Changes in the disease specific Health-related Quality of Life (HRQoL) measured by Mini Asthma Quality of Life Questionnaire (Mini AQLQ)
Prazo: at weeks 2, 4 and 8 from baseline
|
To evaluate changes in the disease specific Health-related Quality of Life (HRQoL) measured by Mini Asthma Quality of Life Questionnaire (Mini AQLQ) at 2, 4 and 8 weeks from baseline in the asthma patients initiated with BGF MDI |
at weeks 2, 4 and 8 from baseline
|
|
Proportion of patients initiated with BGF MDI who achieve the minimal clinically important difference (MCID) in ACQ-5
Prazo: at weeks 2, 4 and 8 from baseline
|
To evaluate proportion of patients initiated with BGF MDI who achieve the minimal clinically important difference (MCID) in ACQ-5 at 2, 4 and 8 weeks from baseline in the asthma patients initiated with BGF MDI |
at weeks 2, 4 and 8 from baseline
|
|
Proportion of patients treated with BGF MDI who achieve the MCID in global Mini AQLQ score
Prazo: at weeks 2, 4, 8 from baseline
|
To evaluate proportion of patients treated with BGF MDI who achieve the MCID in global Mini AQLQ score at 2, 4 and 8 weeks from baseline in the asthma patients initiated with BGF MDI |
at weeks 2, 4, 8 from baseline
|
|
Onset of action of BGF MDI measured by the Onset of Effect Questionnaire (OEQ)
Prazo: 5 and 30 minutes after the first administration
|
To evaluate the onset of action of BGF MDI measured by the Onset of Effect Questionnaire (OEQ) at 5 and 30 minutes after the first administration |
5 and 30 minutes after the first administration
|
|
Changes in the cough and sputum symptoms measured by Cough And Sputum Assessment Questionnaire (CASA-Q)
Prazo: 2, 4 and 8 weeks from baseline
|
To evaluate changes in the cough and sputum symptoms measured by Cough And Sputum Assessment Questionnaire (CASA-Q) at 2, 4 and 8 weeks from baseline in the asthma patients initiated with BGF MDI |
2, 4 and 8 weeks from baseline
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do sistema imunológico
- Doenças Respiratórias
- Doenças pulmonares
- Doenças brônquicas
- Doenças Pulmonares Obstrutivas
- Hipersensibilidade Respiratória
- Hipersensibilidade, Imediata
- Hipersensibilidade
- Asma
- Compostos policíclicos
- Pregnas
- Esteróides
- Compostos de anel fundido
- Greattenenes
- Gestenos
- Budesonida
Outros números de identificação do estudo
- D5980R00145
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Qualified researchers can request access to anonymized individual patient level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Prazo de Compartilhamento de IPD
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Critérios de acesso de compartilhamento IPD
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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