TEV-56248: Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.
Albuterol sulfate: Oral inhalation powder
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
| Facility | City | Region | Status |
|---|---|---|---|
| Teva Investigational Site 15706 | Birmingham | Alabama | |
| Teva Investigational Site 15786 | Birmingham | Alabama | |
| Teva Investigational Site 15768 | Dothan | Alabama | |
| Teva Investigational Site 15581 | Paradise Valley | Arizona | |
| Teva Investigational Site 15710 | Scottsdale | Arizona | |
| Teva Investigational Site 15661 | Tucson | Arizona | |
| Teva Investigational Site 15685 | Bakersfield | California | |
| Teva Investigational Site 15721 | Fresno | California | |
| Teva Investigational Site 15788 | Huntington Beach | California | |
| Teva Investigational Site 15720 | La Jolla | California | |
| Teva Investigational Site 15687 | La Palma | California | |
| Teva Investigational Site 15708 | Long Beach | California | |
| Teva Investigational Site 15712 | Long Beach | California | |
| Teva Investigational Site 15643 | Los Angeles | California | |
| Teva Investigational Site 15695 | Napa | California | |
| Teva Investigational Site 15692 | Northridge | California | |
| Teva Investigational Site 15682 | Redondo Beach | California | |
| Teva Investigational Site 15629 | San Bernardino | California | |
| Teva Investigational Site 15709 | San Diego | California | |
| Teva Investigational Site 15704 | San Jose | California | |
| Teva Investigational Site 15620 | Stockton | California | |
| Teva Investigational Site 15621 | Westminster | California | |
| Teva Investigational Site 15612 | Aurora | Colorado | |
| Teva Investigational Site 15588 | Colorado Springs | Colorado | |
| Teva Investigational Site 15765 | Colorado Springs | Colorado | |
| Teva Investigational Site 15676 | Englewood | Colorado | |
| Teva Investigational Site 15781 | Washington D.C. | District of Columbia | |
| Teva Investigational Site 15660 | Aventura | Florida | |
| Teva Investigational Site 15624 | Cape Coral | Florida | |
| Teva Investigational Site 15598 | Cutler Bay | Florida | |
| Teva Investigational Site 15776 | Doral | Florida | |
| Teva Investigational Site 15579 | Greenacres City | Florida | |
| Teva Investigational Site 15582 | Hialeah | Florida | |
| Teva Investigational Site 15664 | Hialeah | Florida | |
| Teva Investigational Site 15657 | Homestead | Florida | |
| Teva Investigational Site 15713 | Jacksonville | Florida | |
| Teva Investigational Site 15632 | Leesburg | Florida | |
| Teva Investigational Site 15777 | Margate | Florida | |
| Teva Investigational Site 15602 | Miami | Florida | |
| Teva Investigational Site 15722 | Miami | Florida |
+ 353 more sites — see the full list on the official registry below.
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