Replication of the INSPIRE Trial in Healthcare Claims Data

NCT05179512 | Completed FDA Drug

• 1 other identifier: 2018P002966-DUP-INSPIRE
• Study Type: observational
• Target: 98,278
• 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)

• Healthcare utilization exacerbation rate per year

  Claims-based algorithm: healthcare utilization exacerbation rate per year

  Through study completion or censoring, up to 193 days

Study Arms (2)

Tiotropium

Reference group

Drug: Tiotropium

Salmeterol/Fluticasone

Exposure group

Drug: salmeterol-fluticasone

Interventions

Tiotropium DRUG

Tiotropium dispensing claim is used as the reference group.

Tiotropium

salmeterol-fluticasone DRUG

Salmeterol/Fluticasone dispensing claim is used as the exposure group.

Salmeterol/Fluticasone

Eligibility Criteria

• Age: 40 Years - 80 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 tiotropium to salmeterol. The patients will be required to have continuous enrollment during baseline period of 180 days before initiation of SFC or tiotropium inhalers (cohort entry date).

You may qualify if:

• 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

You may not qualify if:

• 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

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

Tiotropium Bromide; Fluticasone-Salmeterol Drug Combination

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)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

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: January 5, 2022
• Study Start: September 22, 2020
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

US (1)