COPDNCT05062304
Replication of the IMPACT COPD Trial in Healthcare Claims Data
An observational study of COPD, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies. Read more about this study
- Who is it for?
- Ages 40 to 120 years
- Conditions the study is for
- COPD
- What is being tested?
- Fluticasone Furoate-Vilanterol Trifenatate and Furoate-umeclidinium-vilanterol
- How many people
- 17,281 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2020to 22 Jul 2021
- 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 40 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will involve a new user, parallel group, propensity score-matched, retrospective cohort study design comparing triple therapy to fluticasone furoate-vilanterol users. The patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of triple therapy or fluticasone furoate-vilanterol (index date). We will restrict the analyses to patients with a diagnosis of COPD who have been receiving daily maintenance therapy for at least 3 months prior to index date.
Who may be able to join
- 40 years of age
- Established clinical history of COPD in accordance with the definition by the ATS/ERS
- Receiving daily maintenance treatment for their COPD for at least 3 months prior to screening
- A post-bronchodilator FEV1 < 50% predicted normal and a documented history of ≥ 1 moderate or severe COPD exacerbation in the previous 12 months OR a post-bronchodilator 50% ≤FEV1 < 80% predicted normal and a documented history of ≥ 2 moderate exacerbations or a documented history of ≥1 severe COPD exacerbation (hospitalized) in the previous 12 months.
Who cannot join
- Pregnancy or child bearing potential without acceptable contraceptive method
- Subjects with α1-antitrypsin deficiency as the underlying cause of COPD
- Subjects with active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
- Subjects with lung volume reduction surgery within the 12 months prior to screening
- Immune suppression (e.g. HIV, Lupus) or other risk factors for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's Disease, Myasthenia Gravis)
- Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening and at least 30 days following the last dose of oral/systemic corticosteroids (if applicable). In addition, any subject that experiences pneumonia and/or moderate or severe COPD exacerbation during the run-in period will be excluded
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- Other Respiratory tract infections that have not resolved at least 7 days prior to screening
- Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices or persistent jaundice, cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). Note: Chronic stable hepatitis B and C are acceptable if the subject otherwise meets entry criteria
- Unstable or life threatening cardiac disease: subjects with any of the following at Screening (Visit 1) would be excluded: Myocardial infarction or unstable angina in the last 6 months
- Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months
- NYHA Class IV Heart failure
- Oxygen therapy: Use of long-term oxygen therapy (LTOT) described as resting oxygen therapy >3L/min (Oxygen use less than or equal to 3L/min flow is not exclusionary.)
- Pulmonary rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening or subjects who plan to enter the acute phase of a Pulmonary Rehabilitation Program during the study. Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program are not excluded
- Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse
- The use of any of the following medications under the given conditions:
- Long term antibiotic use (short term antibiotics are allowed if treating short-term acute infection or short-term exacerbation
- Use of a systemic, oral, or parenteral corticosteroid in the last 30 days (except unless treating COPD exacerbations/pneumonia)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
Official title: Once-Daily Single-Inhaler Triple Versus Dual Therapy in Patients With COPD (IMPACT Trial)
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Read the detailed description
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
- Conditions
- COPD
- Being tested
- Fluticasone Furoate-Vilanterol Trifenatate, Furoate-umeclidinium-vilanterol
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone Furoate-Vilanterol TrifenatateDrug
Fluticasone Furoate-Vilanterol Trifenatate dispensing claim is used as the reference group.
Furoate-umeclidinium-vilanterolDrug
Furoate-umeclidinium-vilanterol dispensing claim is used as the exposure group.
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone furoate-vilanterol | Reference group Receives: Drug: Fluticasone Furoate-Vilanterol Trifenatate | |
| Fluticasone furoate-umeclidinium-vilanterol | Exposure group Receives: Drug: Furoate-umeclidinium-vilanterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual rate of moderate or severe COPD exacerbations during treatment
Claims-based algorithm: see attached protocol for full definition
Measured: To study completion or censoring, up to 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start13 Dec 2020
- Primary completion22 Jul 2021
- Study completion22 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 17,281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirley Vichy Wang, Brigham and Women's Hospital
- Investigators
- Shirley Wang, PhD, ScM, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062304
- Sponsor's protocol ID
- 2018P002966-DUP-IMPACT
- Status last verified
- Jul 2023
- First submitted
- 21 Jun 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Once-Daily Single-Inhaler Triple Versus Dual Therapy in Patients With COPD (IMPACT Trial)
- ClinicalTrials.gov ID
- NCT05062304
- Acronym / sponsor ID
- 2018P002966-DUP-IMPACT
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,281 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 13 Dec 2020 (actual)
- Primary completion
- 22 Jul 2021 (actual)
- Study completion
- 22 Jul 2021 (actual)
- First posted
- 30 Sep 2021 (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.
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Detailed description
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluticasone furoate-vilanterol | – | Drug: Fluticasone Furoate-Vilanterol TrifenatateReference group |
| Fluticasone furoate-umeclidinium-vilanterol | – | Drug: Furoate-umeclidinium-vilanterolExposure group |
Who may qualify
- Ages
- 40 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will involve a new user, parallel group, propensity score-matched, retrospective cohort study design comparing triple therapy to fluticasone furoate-vilanterol users. The patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of triple therapy or fluticasone furoate-vilanterol (index date). We will restrict the analyses to patients with a diagnosis of COPD who have been receiving daily maintenance therapy for at least 3 months prior to index date.
Key inclusion criteria (4 listed)
- 40 years of age
- Established clinical history of COPD in accordance with the definition by the ATS/ERS
- Receiving daily maintenance treatment for their COPD for at least 3 months prior to screening
- A post-bronchodilator FEV1 < 50% predicted normal and a documented history of ≥ 1 moderate or severe COPD exacerbation in the previous 12 months OR a post-bronchodilator 50% ≤FEV1 < 80% predicted normal and a documented history of ≥ 2 moderate exacerbations or a documented history of ≥1 severe COPD exacerbation (hospitalized) in the previous 12 months.
Key exclusion criteria (17 listed)
- Pregnancy or child bearing potential without acceptable contraceptive method
- Subjects with α1-antitrypsin deficiency as the underlying cause of COPD
- Subjects with active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
- Subjects with lung volume reduction surgery within the 12 months prior to screening
- Immune suppression (e.g. HIV, Lupus) or other risk factors for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's Disease, Myasthenia Gravis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone Furoate-Vilanterol TrifenatateFluticasone Furoate-Vilanterol Trifenatate dispensing claim is used as the reference group. | Drug | Fluticasone furoate-vilanterol |
| Furoate-umeclidinium-vilanterolFuroate-umeclidinium-vilanterol dispensing claim is used as the exposure group. | Drug | Fluticasone furoate-umeclidinium-vilanterol |
Primary outcome
Annual rate of moderate or severe COPD exacerbations during treatment
Time frame: To study completion or censoring, up to 32 months
Claims-based algorithm: see attached protocol for full definition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
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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.
Shirley Wang, PhD, ScM principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Brigham and Women's Hospital at 1 site 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 4 inclusion and 17 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: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Annual rate of moderate or severe COPD exacerbations during treatment (time frame: To study completion or censoring, up to 32 months). 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 27 Jul 2023.