ClinicalTrials.gov record
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
ClinicalTrials.gov ID: NCT06052267
Public ClinicalTrials.gov record NCT06052267. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Fixed-Dose Combination on Severe Asthma Exacerbations in Patients With Asthma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT06052267
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,772 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 4 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 30, 2023 (Actual)
- Primary completion
- Oct 31, 2026 (Estimated)
- Completion
- Oct 31, 2026 (Estimated)
- Last update posted
- Oct 14, 2026
2023 – 2026
United States locations
- U.S. sites
- 157
- U.S. states
- 33
- U.S. cities
- 116
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Teva Investigational Site 15706 | Birmingham | Alabama | 35209 | — |
| Teva Investigational Site 15786 | Birmingham | Alabama | 35233 | — |
| Teva Investigational Site 15768 | Dothan | Alabama | 36305 | — |
| Teva Investigational Site 15581 | Paradise Valley | Arizona | 85258 | — |
| Teva Investigational Site 15710 | Scottsdale | Arizona | 85259 | — |
| Teva Investigational Site 15661 | Tucson | Arizona | 85741 | — |
| Teva Investigational Site 15685 | Bakersfield | California | 93301 | — |
| Teva Investigational Site 15721 | Fresno | California | 93704 | — |
| Teva Investigational Site 15788 | Huntington Beach | California | 92647-6853 | — |
| Teva Investigational Site 15720 | La Jolla | California | 92037 | — |
| Teva Investigational Site 15687 | La Palma | California | 90623 | — |
| Teva Investigational Site 15708 | Long Beach | California | 90806-2613 | — |
| Teva Investigational Site 15712 | Long Beach | California | 90815 | — |
| Teva Investigational Site 15643 | Los Angeles | California | 90025 | — |
| Teva Investigational Site 15695 | Napa | California | 94558 | — |
| Teva Investigational Site 15692 | Northridge | California | 91324 | — |
| Teva Investigational Site 15682 | Redondo Beach | California | 90277-5720 | — |
| Teva Investigational Site 15629 | San Bernardino | California | 92408 | — |
| Teva Investigational Site 15709 | San Diego | California | 92120 | — |
| Teva Investigational Site 15704 | San Jose | California | 95117 | — |
| Teva Investigational Site 15620 | Stockton | California | 95207 | — |
| Teva Investigational Site 15621 | Westminster | California | 92683 | — |
| Teva Investigational Site 15612 | Aurora | Colorado | 80014 | — |
| Teva Investigational Site 15588 | Colorado Springs | Colorado | 80907 | — |
| Teva Investigational Site 15765 | Colorado Springs | Colorado | 80922 | — |
| Teva Investigational Site 15676 | Englewood | Colorado | 80110 | — |
| Teva Investigational Site 15781 | Washington D.C. | District of Columbia | 20009 | — |
| Teva Investigational Site 15660 | Aventura | Florida | 33180 | — |
| Teva Investigational Site 15624 | Cape Coral | Florida | 33914 | — |
| Teva Investigational Site 15598 | Cutler Bay | Florida | 33189 | — |
| Teva Investigational Site 15776 | Doral | Florida | 33122 | — |
| Teva Investigational Site 15579 | Greenacres City | Florida | 33476 | — |
| Teva Investigational Site 15582 | Hialeah | Florida | 33012 | — |
| Teva Investigational Site 15664 | Hialeah | Florida | 33012 | — |
| Teva Investigational Site 15657 | Homestead | Florida | 33030 | — |
| Teva Investigational Site 15713 | Jacksonville | Florida | 32207 | — |
| Teva Investigational Site 15632 | Leesburg | Florida | 34748 | — |
| Teva Investigational Site 15777 | Margate | Florida | 33063 | — |
| Teva Investigational Site 15602 | Miami | Florida | 33126 | — |
| Teva Investigational Site 15722 | Miami | Florida | 33126 | — |
| Teva Investigational Site 15724 | Miami | Florida | 33126 | — |
| Teva Investigational Site 15655 | Miami | Florida | 33130 | — |
| Teva Investigational Site 15605 | Miami | Florida | 33142-2946 | — |
| Teva Investigational Site 15634 | Miami | Florida | 33143 | — |
| Teva Investigational Site 15596 | Miami | Florida | 33144 | — |
| Teva Investigational Site 15654 | Miami | Florida | 33144 | — |
| Teva Investigational Site 15773 | Miami | Florida | 33155 | — |
| Teva Investigational Site 15585 | Miami | Florida | 33173 | — |
| Teva Investigational Site 15639 | Miami | Florida | 33173 | — |
| Teva Investigational Site 15645 | Miami | Florida | 33173 | — |
| Teva Investigational Site 15772 | Miami | Florida | 33175 | — |
| Teva Investigational Site 15592 | Miami | Florida | 33176 | — |
| Teva Investigational Site 15769 | Miami | Florida | 33176 | — |
| Teva Investigational Site 15644 | Miami | Florida | 33186 | — |
| Teva Investigational Site 15589 | Miami Lakes | Florida | 33014 | — |
| Teva Investigational Site 15599 | Miami Lakes | Florida | 33014 | — |
| Teva Investigational Site 15595 | Miami Lakes | Florida | 33016 | — |
| Teva Investigational Site 15665 | Oldsmar | Florida | 34677 | — |
| Teva Investigational Site 15659 | Orlando | Florida | 32806 | — |
| Teva Investigational Site 15617 | Orlando | Florida | 32819 | — |
| Teva Investigational Site 15625 | Orlando | Florida | 32825 | — |
| Teva Investigational Site 15597 | Pembroke Pines | Florida | 33025 | — |
| Teva Investigational Site 15767 | Sweetwater | Florida | 33182 | — |
| Teva Investigational Site 15587 | Tamarac | Florida | 33321 | — |
| Teva Investigational Site 15611 | Tampa | Florida | 33604 | — |
| Teva Investigational Site 15619 | Tampa | Florida | 33607-6327 | — |
| Teva Investigational Site 15653 | Tampa | Florida | 33607 | — |
| Teva Investigational Site 15652 | Virginia Gardens | Florida | 33166 | — |
| Teva Investigational Site 15606 | Winter Park | Florida | 32789 | — |
| Teva Investigational Site 15717 | Atlanta | Georgia | 30329 | — |
| Teva Investigational Site 15711 | Conyers | Georgia | 30012 | — |
| Teva Investigational Site 15626 | Savannah | Georgia | 31406-2668 | — |
| Teva Investigational Site 15604 | Boise | Idaho | 83706 | — |
| Teva Investigational Site 15669 | Chicago | Illinois | 60607 | — |
| Teva Investigational Site 15616 | Chicago | Illinois | 60612 | — |
| Teva Investigational Site 15716 | Chicago | Illinois | 60637 | — |
| Teva Investigational Site 15600 | Skokie | Illinois | 60077 | — |
| Teva Investigational Site 15674 | Evansville | Indiana | 47715 | — |
| Teva Investigational Site 15580 | Overland Park | Kansas | 66210 | — |
| Teva Investigational Site 15627 | Lexington | Kentucky | 40509 | — |
| Teva Investigational Site 15770 | Lafayette | Louisiana | 70508 | — |
| Teva Investigational Site 15667 | Bangor | Maine | 04401 | — |
| Teva Investigational Site 15689 | Rockville | Maryland | 20852 | — |
| Teva Investigational Site 15583 | White Marsh | Maryland | 21162 | — |
| Teva Investigational Site 15628 | Boston | Massachusetts | 02115 | — |
| Teva Investigational Site 15686 | Fall River | Massachusetts | 02723 | — |
| Teva Investigational Site 15663 | North Dartmouth | Massachusetts | 02747 | — |
| Teva Investigational Site 15764 | South Dartmouth | Massachusetts | 02747 | — |
| Teva Investigational Site 15702 | Detroit | Michigan | 48202 | — |
| Teva Investigational Site 15701 | Flint | Michigan | 48507 | — |
| Teva Investigational Site 15593 | Ypsilanti | Michigan | 48197 | — |
| Teva Investigational Site 15648 | Kansas City | Missouri | 66160 | — |
| Teva Investigational Site 15640 | St Louis | Missouri | 63110 | — |
| Teva Investigational Site 15650 | St Louis | Missouri | 63123 | — |
| Teva Investigational Site 15633 | St Louis | Missouri | 63141-7068 | — |
| Teva Investigational Site 15790 | Hastings | Nebraska | 68901 | — |
| Teva Investigational Site 15679 | Las Vegas | Nevada | 89123-2875 | — |
| Teva Investigational Site 15725 | North Bergen | New Jersey | 07047 | — |
| Teva Investigational Site 15688 | Hawthorne | New York | 10532 | — |
| Teva Investigational Site 15603 | Horseheads | New York | 14845 | — |
| Teva Investigational Site 15666 | Hyde Park | New York | 11042 | — |
| Teva Investigational Site 15675 | New Windsor | New York | 12553 | — |
| Teva Investigational Site 15618 | Asheville | North Carolina | 28803 | — |
| Teva Investigational Site 15601 | Chapel Hill | North Carolina | 27599 | — |
| Teva Investigational Site 15697 | Charlotte | North Carolina | 28277 | — |
| Teva Investigational Site 15610 | Elizabeth City | North Carolina | 27909-3465 | — |
| Teva Investigational Site 15651 | High Point | North Carolina | 27260 | — |
| Teva Investigational Site 15771 | Statesville | North Carolina | 28625 | — |
| Teva Investigational Site 15631 | Wilmington | North Carolina | 28401 | — |
| Teva Investigational Site 15584 | Winston-Salem | North Carolina | 27157 | — |
| Teva Investigational Site 15607 | Cincinnati | Ohio | 45236 | — |
| Teva Investigational Site 15613 | Columbus | Ohio | 43205 | — |
| Teva Investigational Site 15784 | Dayton | Ohio | 45404 | — |
| Teva Investigational Site 15791 | Dayton | Ohio | 45429 | — |
| Teva Investigational Site 15780 | Toledo | Ohio | 43606 | — |
| Teva Investigational Site 15662 | Toledo | Ohio | 43617 | — |
| Teva Investigational Site 15577 | Oklahoma City | Oklahoma | 73120-9389 | — |
| Teva Investigational Site 15594 | Tulsa | Oklahoma | 74133 | — |
| Teva Investigational Site 15775 | Yukon | Oklahoma | 73099 | — |
| Teva Investigational Site 15646 | Grants Pass | Oregon | 97527 | — |
| Teva Investigational Site 15642 | Philadelphia | Pennsylvania | 19140 | — |
| Teva Investigational Site 15576 | Pittsburgh | Pennsylvania | 15241 | — |
| Teva Investigational Site 15608 | North Charleston | South Carolina | 29420 | — |
| Teva Investigational Site 15672 | Rock Hill | South Carolina | 29732 | — |
| Teva Investigational Site 15691 | Knoxville | Tennessee | 37909 | — |
| Teva Investigational Site 15705 | Austin | Texas | 78759 | — |
| Teva Investigational Site 15641 | Boerne | Texas | 78006 | — |
| Teva Investigational Site 15778 | Brownsville | Texas | 78520 | — |
| Teva Investigational Site 15668 | Corsicana | Texas | 75110 | — |
| Teva Investigational Site 15658 | Dallas | Texas | 75209 | — |
| Teva Investigational Site 15637 | Dallas | Texas | 75231-8206 | — |
| Teva Investigational Site 15623 | Dallas | Texas | 75235 | — |
| Teva Investigational Site 15785 | Edinburg | Texas | 78539 | — |
| Teva Investigational Site 15678 | El Paso | Texas | 79902 | — |
| Teva Investigational Site 15787 | El Paso | Texas | 79902 | — |
| Teva Investigational Site 15591 | El Paso | Texas | 79912 | — |
| Teva Investigational Site 15696 | Houston | Texas | 77008 | — |
| Teva Investigational Site 15714 | Houston | Texas | 77030 | — |
| Teva Investigational Site 15680 | Houston | Texas | 77065 | — |
| Teva Investigational Site 15614 | Houston | Texas | 77074-2005 | — |
| Teva Investigational Site 15578 | Houston | Texas | 77099 | — |
| Teva Investigational Site 15690 | Katy | Texas | 77494 | — |
| Teva Investigational Site 15684 | Kerrville | Texas | 78028 | — |
| Teva Investigational Site 15630 | McKinney | Texas | 75069 | — |
| Teva Investigational Site 15656 | San Antonio | Texas | 78212 | — |
| Teva Investigational Site 15670 | San Antonio | Texas | 78229 | — |
| Teva Investigational Site 15638 | San Antonio | Texas | 78258 | — |
| Teva Investigational Site 15647 | Sherman | Texas | 75090 | — |
| Teva Investigational Site 15673 | Splendora | Texas | 77372 | — |
| Teva Investigational Site 15707 | Tomball | Texas | 77081 | — |
| Teva Investigational Site 15693 | Victoria | Texas | 77901 | — |
| Teva Investigational Site 15649 | Waxahachie | Texas | 75165-1430 | — |
| Teva Investigational Site 15671 | Bountiful | Utah | 84010 | — |
| Teva Investigational Site 15635 | Sandy City | Utah | 84093 | — |
| Teva Investigational Site 15789 | West Valley City | Utah | 84119 | — |
| Teva Investigational Site 15683 | Williamsburg | Virginia | 23188 | — |
| Teva Investigational Site 15586 | Greenfield | Wisconsin | 53228 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 236 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06052267, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 14, 2026 · Synced Oct 28, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06052267 live on ClinicalTrials.gov.