A Study of Patients With Chronic Disease

NCT04263727 | Terminated

• 1 other identifier: TARGET-RWE
• Study Type: observational
• Target: 579
• Locations: 1 country
• Sites: 5

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.

Conditions

Asthma; Chronic Obstructive Pulmonary Disease; Idiopathic Pulmonary Fibrosis; IPF; COPD; Respiratory Disease

Keywords

IPF; COPD; Respiratory Disease; Asthma

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Inability to provide informed assent/consent.

Sponsors & Collaborators

• Target PharmaSolutions, Inc.: lead

Study Sites (5)

Asthma and Allergy Associates, PC

Colorado Springs, Colorado, 80907, United States

Location

St. Francis Medical Institute

Clearwater, Florida, 33765, United States

Location

Family Allergy & Asthma Research Institution

Louisville, Kentucky, 40215, United States

Location

University of Michigan Allergy Specialty Clinic & Food Allergy

Ann Arbor, Michigan, 48106, United States

Location

Coastal Carolina Healthcare, P.A.

New Bern, North Carolina, 28562, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Patients enrolled in TARGET-RWE may be invited to participate in the Biorepository Bank (BSB). Blood samples for biomarker and DNA assays will be collected on a voluntary basis and participation in this project will not affect participation in the main study. These samples will be shipped to a central repository for storage to use in future studies. Samples stored at the biorepository will be identified only with the participant's unique study ID number and the date the sample was obtained.

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Idiopathic Pulmonary Fibrosis; Respiration Disorders

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pulmonary Fibrosis; Lung Diseases, Interstitial

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 11, 2020
• Study Start: February 27, 2020
• Primary Completion: November 21, 2024
• Study Completion: November 21, 2024
• Last Updated: April 3, 2025

Record last verified: 2024-11

Locations

US (5)