Replication of the IMPACT COPD Trial in Healthcare Claims Data
NCT05062304 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 17281
Last updated 2023-07-27
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.
Conditions
Interventions
- DRUG
-
Fluticasone Furoate-Vilanterol Trifenatate
Fluticasone Furoate-Vilanterol Trifenatate dispensing claim is used as the reference group.
- DRUG
-
Furoate-umeclidinium-vilanterol
Furoate-umeclidinium-vilanterol dispensing claim is used as the exposure group.
Sponsors & Collaborators
-
Brigham and Women's Hospital
lead OTHER
Principal Investigators
-
Shirley Wang, PhD, ScM · Brigham and Women's Hospital
Eligibility
- Min Age
- 40 Years
- Max Age
- 120 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-13
- Primary Completion
- 2021-07-22
- Completion
- 2021-07-22
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study to Evaluate the 24 Hour Spirometric Effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate (FF)/25mcg Vilanterol (VI)) Compared With Salmeterol/Fluticasone Propionate Inhalation Powder (50mcg Salmeterol/500mcg Fluticasone Propionate (FP))
NCT01342913 ·Status: COMPLETED ·Phase: PHASE3
-
A Study in Asthmatic Patients to Determine if There is Any Difference in Dosing With Fluticasone Furoate/Vilanterol Inhalation Powder in the Morning or Evening on Lung Function
NCT01287065 ·Status: COMPLETED ·Phase: PHASE2
-
To Evaluate Real-World Effectiveness of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol (FF/UMEC/VI) in a Single Inhaler (Trelegy Ellipta) in Participants With Symptomatic COPD
NCT05535972 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once Daily Compared With Tiotropium Bromide Inhalation Powder 18mcg Once Daily in Subjects With COPD Who Have or Are At Risk for Co-morbid Cardiovascular Disease
NCT01627327 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Compare the Addition of Umeclidinium Bromide (UMEC) to Fluticasone Furoate (FF)/Vilanterol (VI), With Placebo Plus FF/VI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01957163 ·Status: COMPLETED ·Phase: PHASE3
-
12 / 48 wk Pivotal PFT vs PBO in COPD II
NCT00782509 ·Status: COMPLETED ·Phase: PHASE3
-
Study Evaluating the 24-Hour Pulmonary Function Profile of Fluticasone Furoate (FF) /GW642444 (Vilanterol) (VI) Inhalation Powder 100/25mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01323621 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Compare the Addition of Umeclidinium Bromide (UMEC) to Fluticasone Furoate (FF)/Vilanterol (VI), With Placebo Plus FF/VI in Subjects With Chronic Obstructive Pulmonary Disease (COPD) -Study 2
NCT02119286 ·Status: COMPLETED ·Phase: PHASE3
-
A Comparative Study Between Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy Versus Tiotropium Monotherapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT03474081 ·Status: COMPLETED ·Phase: PHASE4
-
A Randomized Study, Comparing Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC /VI) Single Inhaler Triple Therapy, Versus Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT03478696 ·Status: COMPLETED ·Phase: PHASE4
-
A Trial to Assess the Pharmacodynamic Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01168310 ·Status: COMPLETED ·Phase: PHASE2
-
A Study Comparing the Closed Triple Therapy, Open Triple Therapy and a Dual Therapy for Effect on Lung Function in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT02731846 ·Status: WITHDRAWN ·Phase: PHASE3
-
Dose-Ranging Study Of GSK233705B In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT00676052 ·Status: COMPLETED ·Phase: PHASE2
-
Symbicort in Chronic Obstructive Pulmonary Disease
NCT00611520 ·Status: COMPLETED
-
BI 1744 CL With Respimat Once Daily Versus Twice Daily in COPD
NCT00846768 ·Status: COMPLETED ·Phase: PHASE2
-
Comparative Effects of Triple Inhaled Therapy With Budesonide/Glycopyrronium/Formoterol Versus Fluticasone Furoate/Umeclidinium/Vilanterol on Small Airway Disease in COPD Patients: A Randomized Crossover Study
NCT06905483 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of ICS/LABA vs. LAMA/LABA in Patients With Different COPD Phenotypes.
NCT05342558 ·Status: COMPLETED ·Phase: PHASE4
-
A Safety, Pharmacokinetic and Pharmacodynamic Study of PUR0200 in COPD Patients
NCT01921712 ·Status: COMPLETED ·Phase: PHASE1
-
A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease
NCT01033487 ·Status: COMPLETED ·Phase: PHASE2
-
INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design
NCT03467425 ·Status: COMPLETED ·Phase: PHASE4
-
12 / 48 Week Pivotal PFT vs PBO in COPD I
NCT00782210 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol on Survival in Subjects With Chronic Obstructive Pulmonary Disease
NCT01313676 ·Status: COMPLETED ·Phase: PHASE3
-
Phase IV O2 Consumption Study in COPD Patients.
NCT02533505 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Assess the Efficacy of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01706328 ·Status: COMPLETED ·Phase: PHASE3
-
Changes in Cardiac Function in COPD Patients After Administration of Budesonide/Formoterol (Symbicort®) Versus Placebo
NCT01760304 ·Status: TERMINATED ·Phase: PHASE4