A retrospective real-world data study, assessing the relationship between the timing of Budesonide/Glycopyrrolate/Formoterol initiation following an exacerbation and the occurrence of subsequent exacerbations, severe cardiopulmonary events and other real-world outcomes in Japan

Inclusion Criteria:

• Diagnosis of COPD (at any position) before or on the index date

  • 1 dispensation of BGF on or following the launch date of BGF in Japan

• Patients must have evidence of at least one qualifying COPD exacerbation event, which qualify the initiation of triple therapy. The exacerbation event must occur within the 12-month period preceding BGF initiation and on or after BGF launch in Japan (i.e., 04 September 2019). The earliest qualifying COPD exacerbation event will be set as the index date.

  • 12 months of continuous health plan enrollment preceding the qualifying COPD exacerbation date
  • 1 day of continuous enrollment following the qualifying COPD exacerbation date

• Age ≥ 40 years on the qualifying COPD exacerbation date

Exclusion Criteria:

• Presence of ≥ 2 records of respiratory cancer diagnoses occurring at least 1 month apart during the 12-month baseline period preceding the qualifying COPD exacerbation or during the follow-up period
• Presence of ≥ 1 dispensation of SITT during the 12-month baseline period preceding the index date through BGF initiation
• Patients who only have 1 moderate COPD exacerbation in 12-months period prior to BGF initiation with no dispensation of long-acting inhaled COPD maintenance treatment during the 12-months baseline period preceding the qualifying COPD exacerbation.

The overall study population will include adult patients (aged ≥ 40) with COPD in Japan who have experienced a qualifying COPD exacerbation (defining the index date) on or after the BGF launch in Japan (i.e., 04 September 2019) for which triple therapy (i.e., BGF) could have been initiated per local or global guidelines

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.

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.

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.