A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
Condition(s) studied
Investigational drug(s) / intervention(s)
TEV-56248: Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.
Albuterol sulfate: Oral inhalation powder
Study summary
The primary objective of the study is to assess the efficacy of high dose fluticasone propionate (Fp)/albuterol sulfate (ABS) integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS eMDPI in decreasing severe clinical asthma exacerbation (CAEs).
Secondary Objectives:
To evaluate the efficacy of Fp/ABS low dose compared to ABS and the effect on systemic corticosteroid (SCS) exposure
To evaluate the safety and tolerability of Fp/A BS
The duration for each participant will be a minimum of 28 weeks including 2 weeks of screening, 2-4 weeks of run-in period and a double blind treatment period of minimum 24 weeks, however due to the event-driven nature of this study, the duration may range up to approximately 42 months depending on the timing when the participant was enrolled to the study, and when the study reaches its completion criteria
Eligibility
Primary outcome measure(s)
- Time to First Severe Clinical Asthma Exacerbation (CAE) with High Dose (HD) Fp/ABS eMDPI — Up to 42 months
Trial sites (391)
| Facility | City | Region | Status |
|---|---|---|---|
| AllerVie Clnical Research | Birmingham | Alabama | |
| The University of Alabama at Birmingham | Birmingham | Alabama | |
| SEC Clinical Research | Dothan | Alabama | |
| One of a Kind Clinical Research Center LLC | Paradise Valley | Arizona | |
| Mayo Clinic | Scottsdale | Arizona | |
| Novak Clinical Research | Tucson | Arizona | |
| Kern Research, Inc | Bakersfield | California | |
| Clinical Research of Central California, LLC | Fresno | California | |
| Allergy and Asthma Specialists Medical Group | Huntington Beach | California | |
| Orso Health | La Jolla | California | |
| IMAX Clinical Trials | La Palma | California | |
| Long Beach Clinical Trials | Long Beach | California | |
| Ark Clinical Research, LLC | Long Beach | California | |
| Ricardo Antonio Tan Inc | Los Angeles | California | |
| One of a Kind Clinical Research Center LLC | Napa | California | |
| California Medical Research Associates Inc. | Northridge | California | |
| Riviera Allergy Medical Center | Redondo Beach | California | |
| Velocity Clinical Research, Banning | San Bernardino | California | |
| Institute of HealthCare Assessment, Inc | San Diego | California | |
| Allergy and Asthma Associates | San Jose | California | |
| Bensch Clinical Research LLC | Stockton | California | |
| Allianz Research Institute | Westminster | California | |
| Allianz Research Institute | Aurora | Colorado | |
| CRN Clinical Research Network LLC/Asthma and Allergy Associates P.C. | Colorado Springs | Colorado | |
| OptumCare Colorado Springs LLC | Colorado Springs | Colorado | |
| Velocity Clinical Research | Englewood | Colorado | |
| Emerson Clinical Research Institute | Washington D.C. | District of Columbia | |
| Florida Center for Allergy and Asthma Research | Aventura | Florida | |
| Renaissance Research and Medical Group | Cape Coral | Florida | |
| Cenara Clinical Research | Cutler Bay | Florida | |
| D & H Doral Research Centers | Doral | Florida | |
| Finlay Medical Research Corp | Greenacres City | Florida | |
| Direct Helpers Research Center, Inc. | Hialeah | Florida | |
| New Life Research Institute, LLC | Hialeah | Florida | |
| Homestead Medical Research | Homestead | Florida | |
| Nemours Children Clinic | Jacksonville | Florida | |
| Clinical Site Partner, LLC DBA Flourish Research | Leesburg | Florida | |
| D & H Pompano Research Centers, Inc. | Margate | Florida | |
| EMDA Clinical Research | Miami | Florida | |
| Finlay Medical Research | Miami | Florida |
+ 351 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06052267 on ClinicalTrials.gov ↗ ← All trials in the USA