COPD Exacerbation Follow Up

NCT ID: NCT07118306

Last Updated: 2025-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

485 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-31

Study Completion Date

2026-12-31

Brief Summary

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The goal of this study is to evaluate the impact of implementing an AI-enabled clinical workflow tool (Viz COPD) on respiratory specialist follow up and clinical outcomes after an acute exacerbation.

Detailed Description

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Time perspective: This study will collect data prospectively for the Experimental cohort and retrospectively for the Control cohort. There is also an Exploratory cohort which will collect retrospective and prospective data.

Conditions

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COPD (Chronic Obstructive Pulmonary Disease)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Experimental Cohort

Prospective patients presenting to sites after implementation of the digital health tool.

No interventions assigned to this group

Control Cohort

Retrospective patients who presented to the same study sites under the standard of care clinical workflow before implementation of the digital health tool

No interventions assigned to this group

Exploratory Cohort

Patients who had no prior respiratory specialist follow up before implementation of the digital health tool and are re-assessed for follow up after implementation of the digital health tool.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients aged 40 years or older at the time of arrival to the emergency department.
* Patients with a clinical diagnosis of COPD who present to the emergency department for a moderate or severe COPD exacerbation.
* A moderate exacerbation is defined as an acute exacerbation requiring either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics.
* A severe exacerbation is defined as an acute exacerbation requiring hospitalization, or observation for \>24 hours in emergency department/urgent care facility or resulting in death.
* Patients on dual (LABA/LAMA, LABA/ICS, LAMA/ICS) or triple (LABA/LAMA/ICS) long-acting bronchodilator inhalers.

Exclusion Criteria

* Patients on bronchodilator inhaler monotherapy.
* Patients leaving against medical advice or expiring during hospitalization.
* Patients with tracheostomy.
* Patients with advanced cancer.
* Patients who have received a lung transplant.
* Discharge to hospice care.
* Transfer to another hospital.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Viz.ai, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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VIZCOPD03

Identifier Type: -

Identifier Source: org_study_id

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