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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Yoichi Tamai
- Numero di telefono: 070-2453-4913
- Email: yoichi.tamai@astrazeneca.com
Backup dei contatti dello studio
- Nome: Hitomi Uchimura
- Numero di telefono: 06-4802-3600
- Email: hitomi.uchimura@astrazeneca.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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.
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from baseline in Asthma Control Questionnaire-5 (ACQ-5) score
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema immunitario
- Malattie delle vie respiratorie
- Malattie polmonari
- Malattie bronchiali
- Malattie polmonari, ostruttive
- Ipersensibilità respiratoria
- Ipersensibilità, immediata
- Ipersensibilità
- Asma
- Composti policiclici
- In gravidanza
- Steroidi
- Composti anelli fusi
- Gravideniones
- Incinta
- Budesonide
Altri numeri di identificazione dello studio
- D5980R00145
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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.
Periodo di condivisione 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.
Criteri di accesso alla condivisione 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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