Replication of the POET-COPD Trial in Healthcare Claims Data

NCT05083429 | Completed FDA Drug

• 1 other identifier: 2018P002966-DUP-POET-COPD
• Study Type: observational
• Target: 8,716
• 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

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Time to first COPD exacerbation

  Time to first COPD exacerbation

  [Time Frame: To censoring or study completion, up to 365 days]

Secondary Outcomes (1)

• All-cause death

  [Time Frame: To censoring or study completion, up to 365 days]

Study Arms (2)

Salmeterol inhaler

Reference group

Drug: Salmeterol

Tiotropium

Exposure group

Drug: Tiotropium

Interventions

Salmeterol DRUG

Salmeterol inhaler dispensing claim is used as the reference

Salmeterol inhaler

Tiotropium DRUG

Tiotropium dispensing claim is used as the reference

Tiotropium

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

Patients with chronic obstructive pulmonary disease (COPD)

You may qualify if:

• 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 \[-365, -28\]

You may not qualify if:

• 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 \[-180, 0\]

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

Salmeterol Xinafoate; Tiotropium Bromide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

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: September 20, 2021
• First Posted: October 19, 2021
• Study Start: September 22, 2020
• Primary Completion: August 9, 2021
• Study Completion: August 9, 2021
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

US (1)