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Changes in Symptom and Quality of Life in Patients With Uncontrolled Asthma Treated With Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI)

Key facts

Who runs it
AstraZeneca
Trial code
Status
Not yet recruiting
People taking part
200 people, planned
Starts
29 Jan 2027
Expected to end
31 Aug 2027
Type of study
Observational
Treatments tested
  • Budesonide/Glycopyrronium/Formoterol fumarate metered dose inhaler
Record updated
12 November 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patients who have been treated with ICS/LABA/LAMA within 6 months 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 have participated in any interventional studies within 1 year before enrollment
  • Patients who are pregnant, lactating or intending to become pregnant during the study period

About the trial

What the trial wants to find out

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.

The group in the trial

  • 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.

    Treatment: Budesonide/Glycopyrronium/Formoterol fumarate metered dose inhaler

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Record updated
12 November 2026