Loading clinical trials...

EXACERBATIONS AND REAL-WORLD OUTOMES INCLUDING CARDIOPULMONARY EVENTS AMONG PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (MITOS: EROS+CP US Study) | Clinical Trials | Clareo Health

COMPLETED

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)

NCT06742736•AstraZeneca

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•Presence of cancer diagnoses other than basal or squamous cell skin cancer during the baseline or follow-up periods
•Presence of interstitial fibrosis, sarcoidosis, or pulmonary embolism diagnoses during the baseline or follow-up periods
•Presence of triple therapy SITT during the baseline period through BGF initiation

Locations (1)

AstraZeneca

Wilmington, Delaware, United States

Key Dates

Start Date

May 31, 2024

Primary Completion Date

September 30, 2024

Completion Date

September 30, 2024

Last Updated

August 7, 2025

Enrollment

13,000

ACTUAL participants

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

BGF

DRUG

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

NCT06831994

Asthma BronchialeBreast Neoplasms+11 more

View study

RECRUITING

The London COPD Exacerbation Cohort

NCT02755974

Pulmonary Disease, Chronic Obstructive

View study

ACTIVE_NOT_RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

EXACERBATIONS AND REAL-WORLD OUTOMES INCLUDING CARDIOPULMONARY EVENTS AMONG PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (MITOS: EROS+CP US Study)

Inclusion Criteria

Exclusion Criteria

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

The London COPD Exacerbation Cohort

Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent

Air Filtration for COPD in VA Population of Veterans

A Study of the Effect of a Nurse Navigator Program on High Risk Patients

PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)