A Study of Patients With Chronic Disease

Terminated

• Conditions: COPD; Chronic Obstructive Pulmonary Disease; IPF; Asthma; Idiopathic Pulmonary Fibrosis; Respiratory Disease

• Registration Number: NCT04263727
• Lead Sponsor: Target PharmaSolutions, Inc.

Brief Summary

TARGET-RWE is a 10-year, international, longitudinal, observational study of patients with chronic disease designed to specifically address important clinical questions that remain incompletely answered from registration trials. The protocol will follow a master protocol design in which a shared study infrastructure supports progressive development of the registry across the spectrum of chronic diseases.

Detailed Description

The TARGET-RWE master protocol design allows shared study parameters and operational components to be organized within a centralized platform. Utilizing this platform, therapeutic area-aligned Communities with associated Disease-Specific Cohorts (DSC) can be added according to scientific merit and need to address specific research questions in patients diagnosed with chronic diseases. This design capitalizes on a shared, sustainable infrastructure across a diverse patient population, which allows for more efficient coordination and conduct than can be achieved in traditional stand-alone, independently-conducted research studies with narrowly-focused target patient populations. This master protocol design will ultimately support a dynamic program that adapts to the changing landscape of chronic disease management and allows for rapid enrollment and collection of retrospective and long-term prospective data from participants in specific disease areas of interest.

TARGET-RWE currently includes the TARGET-RWE.LUNG Community, with open DSCs for Asthma, COPD and Idiopathic Pulmonary Fibrosis.

Study Timeline

• Study First Submitted: 2020-02-03
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-11
• Study Start: 2020-02-27
• Status Verified: 2024-11
• Primary Completion: 2024-11-21
• Study Completion: 2024-11-21
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 579

Inclusion Criteria

• Adults and children being managed or treated for a chronic disease under study. Diagnosis is based on the clinical judgement of the care provider.
• Patient is anticipated to have continued management of their chronic disease at the participating site.

Exclusion Criteria

• Inability to provide informed assent/consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Natural history of chronic disease under study: Participant demographics	Up to 10 years
Natural history of chronic disease under study: Disease progression	Up to 10 years
Adverse event frequency and severity	Up to 10 years
Natural history of chronic disease under study: Characteristics of chronic diseases under study.	Up to 10 years
Natural history of chronic disease under study: Treatment use	Up to 10 years

Secondary Outcome Measures

Name	Time	Method
Natural history of chronic disease under study: Treatment response	Up to 10 years
Reasons for treatment discontinuation	Up to 10 years
Self-reported patient health measures: Asthma Control Test	Every 12 months for 10 years
Time point of clinical response	Every 12 months for 10 years

Trial Locations

Locations (5)

Asthma and Allergy Associates, PC; 🇺🇸 Colorado Springs, Colorado, United States

University of Michigan Allergy Specialty Clinic & Food Allergy; 🇺🇸 Ann Arbor, Michigan, United States

St. Francis Medical Institute; 🇺🇸 Clearwater, Florida, United States

Family Allergy & Asthma Research Institution; 🇺🇸 Louisville, Kentucky, United States

Coastal Carolina Healthcare, P.A.; 🇺🇸 New Bern, North Carolina, United States