ASPIRE Study: Prescription Pattern and Healthcare Utilization after SABA-Challenged Environment Implementation

PHRR220713-004876

An Observational Study Evaluating Changes in Prescription Patterns of Reliever Therapy on Healthcare Resource Utilization and Asthma-Related Medical Cost in Asthma Patients after the Implementation of a SABA-Challenged

Environment (ASPIRE)

It is a multi-centre, multi-country, observational study, the primary objective of this study are the following:

 

  1. To evaluate the proportion of SABA reduction from 3 or more canisters to less than 3 canisters per year in chronic asthma patients with SABA overuse and pre-index exacerbations, 12 months before and over 12 months after the implementation of the program.
  2. Given the prior objective achieves threshold of 20% of subjects reducing SABA to less than 3 canisters per year, then to evaluate the asthma related HRU and associated cost in chronic asthma patients with SABA overuse and pre-index exacerbations, 12 months before and over 12 months after the implementation of the program.

Regime Classification Priority
2017 - 2022 Research to enhance and extend healthy lives Health behaviors
Start Date Duration in Months Target Completion Date Actual Completion Date
2022-08-01 12 2023-08-01 0000-00-00

Ongoing

Institution Classification Region LTO #
AstraZeneca Pharmaceuticals (Philippines) Inc. Private Business NCR
Institution Region
AstraZeneca Pharmaceuticals (Philippines) Inc. NCR
Name E-Mail Institution and Institution Address
Francis Dominic Jardin francisdominic.jardin@astrazeneca.com AstraZeneca Pharmaceuticals (Phils) Inc.
Name E-Mail Institution and Institution Address
Francis Dominic Jardin francisdominic.jardin@astrazeneca.com AstraZeneca Pharmaceuticals (Phils) Inc.
Name Expertise Affiliation
Adelito N/A Posas Pulmonology Posas Medical Clinic
Anjuli May Jaen Pulmonology Iloilo Doctor's Hospital
Jessie Orcasitas, MD Pulmonology Metro Davao Medical and Research Center
Marie Grace Dawn Isidro Pulmonology West Visayas State University
Reinalyn Cartago Luceno Pulmonology Perpetual Help Medical Center Las Pinas
Ronaldo Panganiban Jr., MD Pulmonology Green City Medical Center
Name of Trial Site Address Principal Investigator Research Ethics Committee
NAME EXPERTISE REC Name Status of Approval
Posas Medical Clinic Puerto Princesa Palawan Adelito N/A Posas Pulmonology
Iloilo Doctor's Hospital Infante St. Molo Iloilo City Anjuli May Jaen Pulmonology
Metro Davao Medical and Research Center Davao Jessie Orcasitas, MD Pulmonology
West Visayas State University E. Lopez St. Jaro Iloilo City Marie Grace Dawn Isidro Pulmonology
Perpetual Help Medical Center Las Pinas Zapote Road Las pInas Metro Manila Reinalyn Cartago Luceno Pulmonology
Green City Medical Center Interchange San Fernando Pampanga Ronaldo Panganiban Jr., MD Pulmonology

Non-clinical Studies

Bronchial Asthma

Primary Objectives
1. To evaluate the proportion of SABA reduction from 3 or more canisters to less than 3 canisters per year in chronic asthma patients with SABA overuse and pre-index exacerbations, 12 months before and over 12 months after the implementation of the program.
2. Given the prior objective achieves threshold of 20% of subjects reducing SABA to less than 3 canisters per year, then to evaluate the asthma-related HRU and associated cost in chronic asthma patients with SABA overuse and pre-index exacerbations, 12 months before and over 12 months after the implementation of the program.

Secondary Objective
1. To evaluate the frequency of severe acute exacerbations in chronic asthma patients with SABA overuse and pre-index exacerbations, 12 months before and over 12 months after the implementation of the program.
2. To evaluate the treatment pattern of AIR prescription in chronic asthma patients with SABA overuse and pre-index exacerbations, 12 months before and over 12 months after the implementation of the program
3. To quantify the primary and secondary outcomes among enrolled patients who switched reliver therapy from SABA to budesonide-formoterol, 12 months before and over 12 months after the implementation of the program
Exploratory Objectives
1. To evaluate the symptom control using GINA assessment for asthma control of enrolled subjects at baseline and at 12 months after baseline
2. To explore the effect of drug-switching of reliever therapy on primary outcomes and severe acute exacerbations of participating hospitals with different switcher rate (subgroup by institution-level)
3. To explore the effect of healthcare system/ payer types on primary outcomes and severe acute exacerbations of participating hospitals (subgroup by institution-level)
4. To explore the percentage of controller and reliever use in enrolled patients according to different asthma severity, 12 months before and over 12 months after the implementation of the program
5. To explore the potential effect of coronavirus disease 2019 (COVID-19) on prescription patterns, asthma-related HRU and respective cost using data 12 months prior to the pandemic

Pending

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