Replication of the INSPIRE Trial in Healthcare Claims Data

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Replication of the INSPIRE Trial in Healthcare Claims Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05179512
• Other study ID #: 2018P002966-DUP-INSPIRE
• Status: Completed
• Start date: September 22, 2020
• Est. completion date: August 30, 2021

Study information

• Verified date: July 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98278
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age between 40-80 years [0,0] days
• Diagnosis of COPD [all available data, 0] days
• Clinical history of at least 1 COPD exacerbation [all available data, -43] days

Exclusion Criteria:

• COPD exacerbation [-42, 0] days
• Asthma, eczema, atopic dermatitis, allergic rhinitis [-180, 0] days
• Known respiratory disorder other than COPD e.g. pulmonary fibrosis or interstitial lung disease (ILD), sarcoidosis, lymphangioleiomyomatosis, primary/pulmonary tuberculosis, cystic fibrosis, pulmonary hypertension/other pulmonary heart disease, lung/pulmonary malignancies, alpha-1 antitrypsin deficiency, pneumoconioses and other lung diseases due to external agents [all available data, 0] days
• Narrow angle glaucoma or prostatic hyperplasia or obstruction of the neck of the bladder [-180, 0] days
• At least one 30-day supply prescription claims for oral alfuzosin, doxazosin, tamsulosin, silodosin, finasteride 5 mg, dutasteride [-180,0] days
• Lung transplant or lung volume reduction surgery (LVRS) [all available data, 0] days
• Daily long term oxygen therapy (LTOT) [all available data, 0] days
• Beta-blockers (except eye drops) [-180, 0] days
• Evidence of alcohol, drug or solvent abuse [-180, 0] days
• Use of salmeterol, tiotropium and fluticasone containing inhaler use [-180, 0] days

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium
Tiotropium dispensing claim is used as the reference group.
• salmeterol-fluticasone
Salmeterol/Fluticasone dispensing claim is used as the exposure group.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healthcare utilization exacerbation rate per year	Claims-based algorithm: healthcare utilization exacerbation rate per year	Through study completion or censoring, up to 193 days