NCT06742736Completed
EXACERBATIONS AND REAL-WORLD OUTOMES INCLUDING CARDIOPULMONARY EVENTS AMONG PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (MITOS: EROS+CP US Study)
EXACERBATIONS AND REAL-WORLD OUTOMES INCLUDING CARDIOPULMONARY EVENTS AMONG PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE INITIATING BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL (MITOS: EROS+CP US Study)
Source: ClinicalTrials.gov · Last updated 7 Aug 2025
Brief summary (registry, in English)
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 the United States
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 13000 (actual)
- First submitted
- 16 Dec 2024
- Start date
- 31 May 2024
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- AstraZeneca
- Diseases
- COPD
- NCT number
- NCT06742736
What you commit to
- Study type: Observational
- Participants enrolled: 13000
- From 31 May 2024 to the primary completion date, 30 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of triple therapy SITT during the baseline period through BGF initiation
Other illness
- Presence of cancer diagnoses other than basal or squamous cell skin cancer during the baseline or follow-up periods
Other
- Presence of interstitial fibrosis, sarcoidosis, or pulmonary embolism diagnoses during the baseline or follow-up periods
Who the study is looking for
- 1 prescription(s) fill for BGF on or following July 24, 2020 (date of BGF approval in the United States)
- Patients must have evidence a qualifying exacerbation events which, per local or global guidelines, would qualify a patient to have treatment escalated or initiated to triple therapy. The qualifying exacerbation event must occur within the 12-month period preceding the initiation of BGF but occurring on or following local BGF commercial availability (July 24, 2020) and includes either of the following
- 12 months of continuous health plan enrollment preceding the qualifying index exacerbation event date ('baseline' period)
- 1 day of continuous enrollment following the qualifying index exacerbation date
- Age ≥ 40 years on the qualifying index exacerbation event
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AstraZeneca Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.