Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)
Public ClinicalTrials.gov record NCT04609878. 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, Double Dummy, Parallel Group, Multicenter Variable Length Study to Assess the Efficacy and Safety of PT010 Relative to PT009 and Symbicort® in Adult and Adolescent Participants With Inadequately Controlled Asthma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care
Study identification
- NCT ID
- NCT04609878
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,274 participants
Conditions and interventions
Conditions
Interventions
- BGF MDI 320/28.8/9.6 μg Drug
- BGF MDI 320/14.4/9.6 μg Drug
- BFF MDI 320/9.6 μg Drug
- BFF pMDI 320/9 μg Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years to 80 Years
- 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
- Dec 15, 2020 (Actual)
- Primary completion
- Mar 21, 2025 (Actual)
- Completion
- Mar 21, 2025 (Actual)
- Last update posted
- Jun 30, 2026
2020 – 2025
United States locations
- U.S. sites
- 107
- U.S. states
- 36
- U.S. cities
- 99
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Saraland | Alabama | 36571 | — |
| Research Site | Phoenix | Arizona | 85018 | — |
| Research Site | Phoenix | Arizona | 85027 | — |
| Research Site | Sun City West | Arizona | 85375 | — |
| Research Site | Tucson | Arizona | 85715 | — |
| Research Site | Tucson | Arizona | 85745 | — |
| Research Site | Little Rock | Arkansas | 72209 | — |
| Research Site | Covina | California | 91723 | — |
| Research Site | Encinitas | California | 92024 | — |
| Research Site | Fresno | California | 93701 | — |
| Research Site | Laguna Hills | California | 92653 | — |
| Research Site | Long Beach | California | 90806 | — |
| Research Site | Los Angeles | California | 90017 | — |
| Research Site | Los Angeles | California | 90027 | — |
| Research Site | Mission Hills | California | 91345 | — |
| Research Site | Newport Beach | California | 92663 | — |
| Research Site | Northridge | California | 91324 | — |
| Research Site | San Diego | California | 92119 | — |
| Research Site | Stockton | California | 95207 | — |
| Research Site | Thousand Oaks | California | 91360 | — |
| Research Site | Upland | California | 91786 | — |
| Research Site | Westminster | California | 92683 | — |
| Research Site | Colorado Springs | Colorado | 80923 | — |
| Research Site | Lakewood | Colorado | 80228 | — |
| Research Site | Brandon | Florida | 33511 | — |
| Research Site | Miami | Florida | 33175 | — |
| Research Site | Tampa | Florida | 33607 | — |
| Research Site | Adairsville | Georgia | 30103 | — |
| Research Site | Atlanta | Georgia | 30344 | — |
| Research Site | Columbus | Georgia | 31904 | — |
| Research Site | Lawrenceville | Georgia | 30046 | — |
| Research Site | Rincon | Georgia | 31326 | — |
| Research Site | Savannah | Georgia | 31406 | — |
| Research Site | Tyrone | Georgia | 30290 | — |
| Research Site | Chicago | Illinois | 60657 | — |
| Research Site | River Forest | Illinois | 60305 | — |
| Research Site | Brownsburg | Indiana | 46112 | — |
| Research Site | Indianapolis | Indiana | 46202 | — |
| Research Site | Louisville | Kentucky | 40217 | — |
| Research Site | Crowley | Louisiana | 70526 | — |
| Research Site | Lafayette | Louisiana | 70508 | — |
| Research Site | Lake Charles | Louisiana | 70601 | — |
| Research Site | Bangor | Maine | 04401 | — |
| Research Site | Potomac | Maryland | 20854 | — |
| Research Site | Waldorf | Maryland | 20601 | — |
| Research Site | Boston | Massachusetts | 02115 | — |
| Research Site | Hannibal | Missouri | 63401 | — |
| Research Site | St Louis | Missouri | 63141 | — |
| Research Site | Missoula | Montana | 59808 | — |
| Research Site | Bellevue | Nebraska | 68123 | — |
| Research Site | Lincoln | Nebraska | 68510 | — |
| Research Site | Las Vegas | Nevada | 89106 | — |
| Research Site | Toms River | New Jersey | 08755 | — |
| Research Site | Albuquerque | New Mexico | 87108 | — |
| Research Site | New Hyde Park | New York | 11042 | — |
| Research Site | New Windsor | New York | 12553 | — |
| Research Site | New York | New York | 10016 | — |
| Research Site | The Bronx | New York | 10455 | — |
| Research Site | Charlotte | North Carolina | 28277 | — |
| Research Site | Denver | North Carolina | 28037 | — |
| Research Site | Gastonia | North Carolina | 28054 | — |
| Research Site | Raleigh | North Carolina | 27607 | — |
| Research Site | Fargo | North Dakota | 58104 | — |
| Research Site | Cincinnati | Ohio | 45229 | — |
| Research Site | Cincinnati | Ohio | 45231 | — |
| Research Site | Maumee | Ohio | 43537 | — |
| Research Site | Toledo | Ohio | 43617 | — |
| Research Site | Edmond | Oklahoma | 73034 | — |
| Research Site | Oklahoma City | Oklahoma | 73120 | — |
| Research Site | Tulsa | Oklahoma | 74133 | — |
| Research Site | Grants Pass | Oregon | 97527 | — |
| Research Site | DuBois | Pennsylvania | 15801 | — |
| Research Site | Pittsburgh | Pennsylvania | 15236 | — |
| Research Site | Pittsburgh | Pennsylvania | 15241 | — |
| Research Site | Scottdale | Pennsylvania | 15683 | — |
| Research Site | Smithfield | Pennsylvania | 15478 | — |
| Research Site | East Providence | Rhode Island | 02914 | — |
| Research Site | Anderson | South Carolina | 29621 | — |
| Research Site | Greenville | South Carolina | 29607 | — |
| Research Site | North Charleston | South Carolina | 29406 | — |
| Research Site | Franklin | Tennessee | 37067 | — |
| Research Site | Amarillo | Texas | 79106 | — |
| Research Site | Austin | Texas | 78759 | — |
| Research Site | Boerne | Texas | 78006 | — |
| Research Site | Cypress | Texas | 77429 | — |
| Research Site | Dallas | Texas | 75231 | — |
| Research Site | El Paso | Texas | 79912 | — |
| Research Site | Harlingen | Texas | 78550 | — |
| Research Site | Houston | Texas | 77021 | — |
| Research Site | Houston | Texas | 77030 | — |
| Research Site | Kerrville | Texas | 78028 | — |
| Research Site | Lampasas | Texas | 76550 | — |
| Research Site | Nederland | Texas | 77627 | — |
| Research Site | Pearland | Texas | 77584 | — |
| Research Site | Red Oak | Texas | 75154 | — |
| Research Site | San Antonio | Texas | 78215 | — |
| Research Site | San Antonio | Texas | 78229 | — |
| Research Site | San Antonio | Texas | 78258 | — |
| Research Site | Spring | Texas | 77386 | — |
| Research Site | Tomball | Texas | 77375 | — |
| Research Site | Ogden | Utah | 84404 | — |
| Research Site | West Valley City | Utah | 84120 | — |
| Research Site | Colchester | Vermont | 05446 | — |
| Research Site | Manassas | Virginia | 20110 | — |
| Research Site | Kingwood | West Virginia | 26537 | — |
| Research Site | Morgantown | West Virginia | 26505 | — |
| Research Site | Cudahy | Wisconsin | 53110 | — |
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 253 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04609878, 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 Jun 30, 2026 · Synced Oct 17, 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 NCT04609878 live on ClinicalTrials.gov.