AsthmaNCT04263727
A Study of Patients With Chronic Disease
An observational study of Asthma and Chronic Obstructive Pulmonary Disease, run by Target PharmaSolutions, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis
- How many people
- 579 participants
- Where
- 5 sitesUnited States
- Study dates
- 27 Feb 2020to 21 Nov 2024
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults and children with chronic disease in the United States and Europe.
Who may be able to join
- 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.
Who cannot join
- Inability to provide informed assent/consent.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan Allergy Specialty Clinic & Food Allergy
Ann Arbor, Michigan, 48106
St. Francis Medical Institute
Clearwater, Florida, 33765
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, 80907
Family Allergy & Asthma Research Institution
Louisville, Kentucky, 40215
Coastal Carolina Healthcare, P.A.
New Bern, North Carolina, 28562
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis, IPF, COPD, Respiratory Disease
- Keywords
- IPF, COPD, Respiratory Disease, Asthma
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Idiopathic Pulmonary Fibrosis, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Natural history of chronic disease under study: Characteristics of chronic diseases under study.
Measured: Up to 10 years
Natural history of chronic disease under study: Participant demographics
Measured: Up to 10 years
Natural history of chronic disease under study: Treatment use
Measured: Up to 10 years
Natural history of chronic disease under study: Disease progression
Measured: Up to 10 years
Adverse event frequency and severity
Measured: Up to 10 years
Secondary outcomes (4)
Natural history of chronic disease under study: Treatment response
Measured: Up to 10 years
Time point of clinical response
Measured: Every 12 months for 10 years
Reasons for treatment discontinuation
Measured: Up to 10 years
Self-reported patient health measures: Asthma Control Test
Measured: Every 12 months for 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start27 Feb 2020
- Primary completion21 Nov 2024
- Study completion21 Nov 2024
Why it stopped: Sponsor decision to terminate study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 579 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Target PharmaSolutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263727
- Sponsor's protocol ID
- TARGET-RWE
- Status last verified
- Nov 2024
- First submitted
- 3 Feb 2020
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Observational Study of Patients With Chronic Disease
- ClinicalTrials.gov ID
- NCT04263727
- Acronym / sponsor ID
- TARGET-RWE
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis, IPF, COPD, Respiratory Disease
- Keywords
- IPF, COPD, Respiratory Disease, Asthma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor decision to terminate study
- Enrolment
- 579 participants (actual)
- Lead sponsor
- Target PharmaSolutions, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 21 Nov 2024 (actual)
- Study completion
- 21 Nov 2024 (actual)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and children with chronic disease in the United States and Europe.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Inability to provide informed assent/consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Natural history of chronic disease under study: Characteristics of chronic diseases under study.
Time frame: Up to 10 years
Natural history of chronic disease under study: Participant demographics
Time frame: Up to 10 years
Natural history of chronic disease under study: Treatment use
Time frame: Up to 10 years
Natural history of chronic disease under study: Disease progression
Time frame: Up to 10 years
Adverse event frequency and severity
Time frame: Up to 10 years
4 secondary outcomes
Natural history of chronic disease under study: Treatment response
Time frame: Up to 10 years
Time point of clinical response
Time frame: Every 12 months for 10 years
Reasons for treatment discontinuation
Time frame: Up to 10 years
Self-reported patient health measures: Asthma Control Test
Time frame: Every 12 months for 10 years
Results and safety
The study was stopped early (reason given: Sponsor decision to terminate study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Chronic Obstructive Pulmonary Disease, run by Target PharmaSolutions, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision to terminate study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Natural history of chronic disease under study: Characteristics of chronic diseases under study. (time frame: Up to 10 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.