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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05083429
Other study ID # 2018P002966-DUP-POET-COPD
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 22, 2020
Est. completion date August 9, 2021

Study information

Verified date July 2023
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
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 8716
Est. completion date August 9, 2021
Est. primary completion date August 9, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years to 120 Years
Eligibility Inclusion Criteria: - Age greater or equal than 40: days [0,0] - Diagnosis of COPD: days [-All Data, 0] - History of at least 1 COPD exacerbation within the past year requiring treatment with antibiotics and/or systemic steroids and/or requiring hospitalization: days [-365, -28] Exclusion Criteria: - Patients with 3 diagnosis of asthma: days [-180, 0] - Patients with current severe cardiovascular disorders (Heart Transplantation, LVAD/Implantable heart, Pulmonary hypertension/other pulmonary disease) and use of systemic corticosteroid medication at unstable doses: days [-365, 0] - Patients with any respiratory infection (Acute respiratory infections, pneumonia and influenza) or COPD exacerbation: days [-28, 0] - Exclude use of salmeterol or tiotropium containing inhaler use [-180, 0]

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Salmeterol
Salmeterol inhaler dispensing claim is used as the reference
Tiotropium
Tiotropium dispensing claim is used as the reference

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 Time to first COPD exacerbation Time to first COPD exacerbation [Time Frame: To censoring or study completion, up to 365 days]
Secondary All-cause death All-cause death [Time Frame: To censoring or study completion, up to 365 days]
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