A Study of Patients With Chronic Disease

A Longitudinal Observational Study of Patients With Chronic Disease

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 579

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Asthma and Allergy Associates, PC
  • Florida
    • Clearwater, Florida, United States, 33765
      • St. Francis Medical Institute
  • Kentucky
    • Louisville, Kentucky, United States, 40215
      • Family Allergy & Asthma Research Institution
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • University of Michigan Allergy Specialty Clinic & Food Allergy
  • North Carolina
    • New Bern, North Carolina, United States, 28562
      • Coastal Carolina Healthcare, P.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults and children with chronic disease in the United States and Europe.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Asthma; Non-Interventional. Patients with asthma will be screened and enrolled into the active Asthma disease-specific cohort.
Chronic Obstructive Pulmonary Disease (COPD); Non-Interventional. Patients with COPD will be screened into the inactive COPD disease-specific cohort.
Idiopathic Pulmonary Fibrosis (IPF); Non-Interventional. Patients with IPF will be screened into the inactive IPF disease-specific cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Natural history of chronic disease under study: Characteristics of chronic diseases under study.	Up to 10 years
Natural history of chronic disease under study: Participant demographics	Up to 10 years
Natural history of chronic disease under study: Treatment use	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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Target PharmaSolutions, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2020
• Primary Completion (Actual): November 21, 2024
• Study Completion (Actual): November 21, 2024

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Asthma; COPD; IPF; Respiratory Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Respiratory Tract Diseases; Respiration Disorders; Chronic Disease
• Other Study ID Numbers: TARGET-RWE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No