Replication of the IMPACT COPD Trial in Healthcare Claims Data

NCT05062304 | Completed FDA Drug

• 1 other identifier: 2018P002966-DUP-IMPACT
• Study Type: observational
• Target: 17,281
• Locations: 1 country
• Sites: 1

Brief 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

COPD

Outcome Measures

Primary Outcomes (1)

• Annual rate of moderate or severe COPD exacerbations during treatment

  Claims-based algorithm: see attached protocol for full definition

  To study completion or censoring, up to 32 months

Study Arms (2)

Fluticasone furoate-vilanterol

Reference group

Drug: Fluticasone Furoate-Vilanterol Trifenatate

Fluticasone furoate-umeclidinium-vilanterol

Exposure group

Drug: Furoate-umeclidinium-vilanterol

Interventions

Fluticasone Furoate-Vilanterol Trifenatate DRUG

Fluticasone Furoate-Vilanterol Trifenatate dispensing claim is used as the reference group.

Fluticasone furoate-vilanterol

Furoate-umeclidinium-vilanterol DRUG

Furoate-umeclidinium-vilanterol dispensing claim is used as the exposure group.

Fluticasone furoate-umeclidinium-vilanterol

Eligibility Criteria

• Age: 40 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

fluticasone furoate-vilanterol trifenatate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shirley Wang, PhD, ScM

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: September 30, 2021
• Study Start: December 13, 2020
• Primary Completion: July 22, 2021
• Study Completion: July 22, 2021
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

US (1)