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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Yoichi Tamai
- Puhelinnumero: 070-2453-4913
- Sähköposti: yoichi.tamai@astrazeneca.com
Tutki yhteystietojen varmuuskopiointi
- Nimi: Hitomi Uchimura
- Puhelinnumero: 06-4802-3600
- Sähköposti: hitomi.uchimura@astrazeneca.com
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
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.
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: COHORT
- Aikanäkymät: PROSPECTIVE
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
|
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.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change from baseline in Asthma Control Questionnaire-5 (ACQ-5) score
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- D5980R00145
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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.
IPD-jaon aikakehys
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.
IPD-jaon käyttöoikeuskriteerit
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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