Clinical trial NCT04263727: A Study of Patients With Chronic Disease
Official title: A Longitudinal Observational Study of Patients With Chronic Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Asthma
Chronic Obstructive Pulmonary Disease
Idiopathic Pulmonary Fibrosis
IPF
COPD
Respiratory Disease
Keywords: IPF
COPD
Respiratory Disease
Asthma
Lead sponsor: Target PharmaSolutions, Inc.
Sponsor class: INDUSTRY
First posted: 2020-02-11
Enrollment: 579
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and children with chronic disease in the United States and Europe.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Natural history of chronic disease under study: Characteristics of chronic diseases under study.
timeFrame: Up to 10 years
measure: Natural history of chronic disease under study: Participant demographics
timeFrame: Up to 10 years
measure: Natural history of chronic disease under study: Treatment use
timeFrame: Up to 10 years
measure: Natural history of chronic disease under study: Disease progression
timeFrame: Up to 10 years
measure: Adverse event frequency and severity
timeFrame: Up to 10 years
Secondary outcomes:
measure: Natural history of chronic disease under study: Treatment response
timeFrame: Up to 10 years
measure: Time point of clinical response
timeFrame: Every 12 months for 10 years
measure: Reasons for treatment discontinuation
timeFrame: Up to 10 years
measure: Self-reported patient health measures: Asthma Control Test
timeFrame: Every 12 months for 10 years
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Asthma and Allergy Associates, PC
state: Colorado
city: Clearwater
country: United States
facility: St. Francis Medical Institute
state: Florida
city: Louisville
country: United States
facility: Family Allergy & Asthma Research Institution
state: Kentucky
city: Ann Arbor
country: United States
facility: University of Michigan Allergy Specialty Clinic & Food Allergy
state: Michigan
city: New Bern
country: United States
facility: Coastal Carolina Healthcare, P.A.
state: North Carolina
Study officials:
References: