- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05062304
Replication of the IMPACT COPD Trial in Healthcare Claims Data
Once-Daily Single-Inhaler Triple Versus Dual Therapy in Patients With COPD (IMPACT Trial)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02120
- Brigham and Women's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.
All 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).
Eligible Cohort Entry Dates:
Market availability of fluticasone furoate-umeclidinium-vilanterol in the U.S. for management of COPD was approved by FDA on September 18, 2017.
- For Marketscan: September 18, 2017 - December 31, 2018 (end of available data)
- For Optum: September 18, 2017 - June 30, 2020 (end of available data)
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Fluticasone furoate-vilanterol
Reference group
|
Fluticasone Furoate-Vilanterol Trifenatate dispensing claim is used as the reference group.
|
Fluticasone furoate-umeclidinium-vilanterol
Exposure group
|
Furoate-umeclidinium-vilanterol dispensing claim is used as the exposure group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
To study completion or censoring, up to 32 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shirley Wang, PhD, ScM, Brigham and Women's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018P002966-DUP-IMPACT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COPD
-
University Medical Center GroningenCompleted
-
Istituto Nazionale di Ricovero e Cura per AnzianiRecruiting
-
Bio-Sensing Solutions S.L. (DyCare)Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Centre...Not yet recruiting
-
Sir Run Run Shaw HospitalRecruiting
-
University Hospital, BrestRecruiting
-
The First Affiliated Hospital of Guangzhou Medical...Recruiting
-
Association des Réseaux BronchioliteLaboratoire Système et Matériaux pour la Mécatronique (SYMME)Recruiting
-
Baylor Research InstituteNot yet recruiting
-
Polytechnic Institute of PortoNippon Gases PortugalRecruiting
Clinical Trials on Fluticasone Furoate-Vilanterol Trifenatate
-
GlaxoSmithKlineCompletedAsthmaUnited States, Argentina, Germany, Romania, Russian Federation, Ukraine, Chile, Sweden, Mexico, Netherlands, Poland
-
GlaxoSmithKlineCompletedAsthmaKorea, Republic of, China, Philippines
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited States, Argentina, Japan, Poland, Romania, Russian Federation, Spain, Ukraine, Germany, Taiwan, Bulgaria, Hungary, France, Philippines, South Africa, Thailand, Israel, Korea, Republic of, Australia, Mexico, Slovakia, United... and more
-
Bispebjerg HospitalRigshospitalet, DenmarkCompletedPharmacokineticsDenmark
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited States, Germany, Japan, Ukraine, Estonia, Belgium, France, Sweden, Netherlands, Philippines, Denmark, Hungary, Norway, Slovakia
-
Morten Hostrup, PhDRecruiting
-
GlaxoSmithKlineNot yet recruitingAsthmaUnited States, Argentina, Japan, Taiwan, Canada, Korea, Republic of, Australia
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited States, Germany, Japan, Poland, Romania, Russian Federation, Ukraine, Taiwan, Bulgaria, South Africa, Korea, Republic of
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited States, Germany, Spain, Netherlands, Canada