ClinicalTrials.gov record
A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) in Adults and Children 4 Years of Age or Older With Asthma
ClinicalTrials.gov ID: NCT03769090
Public ClinicalTrials.gov record NCT03769090. 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 Long-term, Randomized, Double-blind, Multicenter, Parallel-group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT007 Administered as Needed in Response to Symptoms in Symptomatic Adults and Children 4 Years of Age or Older With Asthma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a randomized, double-blind, multicenter, parallel-group, variable-length study to compare 2 doses of BDA MDI (PT027) with AS MDI (PT007) on the time to first severe asthma exacerbation in adult, adolescent, and pediatric subjects with moderate to severe asthma.
Study identification
- NCT ID
- NCT03769090
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 3,132 participants
Conditions and interventions
Conditions
Interventions
- Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg Combination Product
- Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg Combination Product
- Albuterol sulfate metered-dose inhaler 180 μg Drug
Combination Product · Drug
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
- Dec 13, 2018 (Actual)
- Primary completion
- Aug 19, 2021 (Actual)
- Completion
- Feb 7, 2022 (Actual)
- Last update posted
- Sep 28, 2022
2018 – 2022
United States locations
- U.S. sites
- 170
- U.S. states
- 36
- U.S. cities
- 142
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35209 | — |
| Research Site | Huntsville | Alabama | 35801 | — |
| Research Site | Mobile | Alabama | 36608 | — |
| Research Site | Montgomery | Alabama | 36106 | — |
| Research Site | Scottsboro | Alabama | 35768 | — |
| Research Site | Sheffield | Alabama | 35660 | — |
| Research Site | Tuscumbia | Alabama | 35674 | — |
| Research Site | Glendale | Arizona | 85306 | — |
| Research Site | Peoria | Arizona | 85381 | — |
| Research Site | Scottsdale | Arizona | 85251 | — |
| Research Site | Little Rock | Arkansas | 72209 | — |
| Research Site | Bakersfield | California | 93301 | — |
| Research Site | Bellflower | California | 90706 | — |
| Research Site | Canoga Park | California | 91304 | — |
| Research Site | Encinitas | California | 92024 | — |
| Research Site | Hawthorne | California | 90250 | — |
| Research Site | Long Beach | California | 90806 | — |
| Research Site | Los Angeles | California | 90017 | — |
| Research Site | Los Angeles | California | 90025 | — |
| Research Site | Los Angeles | California | 90048 | — |
| Research Site | Newport Beach | California | 92663 | — |
| Research Site | Rancho Cucamonga | California | 91730 | — |
| Research Site | Redwood City | California | 94063 | — |
| Research Site | Sacramento | California | 95823 | — |
| Research Site | San Diego | California | 92120 | — |
| Research Site | San Francisco | California | 94102 | — |
| Research Site | San Jose | California | 95117 | — |
| Research Site | Westminster | California | 92683 | — |
| Research Site | Aurora | Colorado | 80045 | — |
| Research Site | Colorado Springs | Colorado | 80907 | — |
| Research Site | Colorado Springs | Colorado | 80909 | — |
| Research Site | Denver | Colorado | 80206 | — |
| Research Site | Denver | Colorado | 80230 | — |
| Research Site | Denver | Colorado | 80246 | — |
| Research Site | Waterbury | Connecticut | 06708 | — |
| Research Site | Aventura | Florida | 33180 | — |
| Research Site | Boynton Beach | Florida | 33436 | — |
| Research Site | Cape Coral | Florida | 33991 | — |
| Research Site | Clearwater | Florida | 33756 | — |
| Research Site | Clearwater | Florida | 33765 | — |
| Research Site | DeLand | Florida | 32720 | — |
| Research Site | Gainesville | Florida | 32653 | — |
| Research Site | Greenacres City | Florida | 33467 | — |
| Research Site | Hialeah | Florida | 33012 | — |
| Research Site | Kissimmee | Florida | 34741 | — |
| Research Site | Miami | Florida | 33125 | — |
| Research Site | Miami | Florida | 33126 | — |
| Research Site | Miami | Florida | 33135 | — |
| Research Site | Miami | Florida | 33144 | — |
| Research Site | Miami | Florida | 33173 | — |
| Research Site | Miami | Florida | 33174 | — |
| Research Site | Miami | Florida | 33175 | — |
| Research Site | Miami | Florida | 33186 | — |
| Research Site | Orlando | Florida | 32806 | — |
| Research Site | Orlando | Florida | 32819 | — |
| Research Site | Oviedo | Florida | 32765 | — |
| Research Site | Palmetto Bay | Florida | 33157 | — |
| Research Site | Panama City | Florida | 32405 | — |
| Research Site | Pembroke Pines | Florida | 33024 | — |
| Research Site | Pembroke Pines | Florida | 33026 | — |
| Research Site | St. Petersburg | Florida | 33707 | — |
| Research Site | St. Petersburg | Florida | 33710 | — |
| Research Site | Albany | Georgia | 31707 | — |
| Research Site | Winder | Georgia | 30680 | — |
| Research Site | Meridian | Idaho | 83646 | — |
| Research Site | Chicago | Illinois | 60644 | — |
| Research Site | Normal | Illinois | 61761 | — |
| Research Site | Iowa City | Iowa | 52242 | — |
| Research Site | Overland Park | Kansas | 66210 | — |
| Research Site | Topeka | Kansas | 66606 | — |
| Research Site | Owensboro | Kentucky | 42301 | — |
| Research Site | Bangor | Maine | 04401 | — |
| Research Site | Baltimore | Maryland | 21209 | — |
| Research Site | Chevy Chase | Maryland | 20815 | — |
| Research Site | White Marsh | Maryland | 21162 | — |
| Research Site | Boston | Massachusetts | 02115 | — |
| Research Site | Fall River | Massachusetts | 02723 | — |
| Research Site | North Dartmouth | Massachusetts | 02747 | — |
| Research Site | Ann Arbor | Michigan | 48106 | — |
| Research Site | Ann Arbor | Michigan | 48109 | — |
| Research Site | Farmington Hills | Michigan | 48336 | — |
| Research Site | Flint | Michigan | 48504 | — |
| Research Site | Flint | Michigan | 48507 | — |
| Research Site | Hamtramck | Michigan | 48212 | — |
| Research Site | Rochester | Michigan | 48307 | — |
| Research Site | Rochester Hills | Michigan | 48307 | — |
| Research Site | Ypsilanti | Michigan | 48197 | — |
| Research Site | Hazelwood | Missouri | 63042 | — |
| Research Site | St Louis | Missouri | 63110 | — |
| Research Site | St Louis | Missouri | 63141 | — |
| Research Site | Bellevue | Nebraska | 68005 | — |
| Research Site | Bellevue | Nebraska | 68123 | — |
| Research Site | Lincoln | Nebraska | 68505 | — |
| Research Site | Las Vegas | Nevada | 89106 | — |
| Research Site | Brick | New Jersey | 08724 | — |
| Research Site | Marlton | New Jersey | 08053 | — |
| Research Site | New Brunswick | New Jersey | 08901 | — |
| Research Site | Toms River | New Jersey | 08755 | — |
| Research Site | Albuquerque | New Mexico | 87131 | — |
| Research Site | Brooklyn | New York | 11230 | — |
| Research Site | New Hyde Park | New York | 11040 | — |
| Research Site | Potsdam | New York | 13676 | — |
| Research Site | The Bronx | New York | 10461 | — |
| Research Site | Asheville | North Carolina | 28801 | — |
| Research Site | Charlotte | North Carolina | 28207 | — |
| Research Site | Charlotte | North Carolina | 28210 | — |
| Research Site | Charlotte | North Carolina | 28277 | — |
| Research Site | Gastonia | North Carolina | 28054 | — |
| Research Site | High Point | North Carolina | 27262 | — |
| Research Site | Monroe | North Carolina | 28112 | — |
| Research Site | Raleigh | North Carolina | 27607 | — |
| Research Site | Winston-Salem | North Carolina | 27104 | — |
| Research Site | Fargo | North Dakota | 58104 | — |
| Research Site | Cincinnati | Ohio | 45231 | — |
| Research Site | Cincinnati | Ohio | 45242 | — |
| Research Site | Columbus | Ohio | 43207 | — |
| Research Site | Dayton | Ohio | 45406 | — |
| Research Site | Dayton | Ohio | 45459 | — |
| Research Site | Dublin | Ohio | 43016 | — |
| Research Site | Mayfield Heights | Ohio | 44124 | — |
| Research Site | Edmond | Oklahoma | 73034 | — |
| Research Site | Oklahoma City | Oklahoma | 73112 | — |
| Research Site | Tulsa | Oklahoma | 74136 | — |
| Research Site | Medford | Oregon | 97504 | — |
| Research Site | Blue Bell | Pennsylvania | 19422 | — |
| Research Site | Erie | Pennsylvania | 16508 | — |
| Research Site | Philadelphia | Pennsylvania | 19140 | — |
| Research Site | Pittsburgh | Pennsylvania | 15241 | — |
| Research Site | East Providence | Rhode Island | 02914 | — |
| Research Site | Providence | Rhode Island | 02908 | — |
| Research Site | Warwick | Rhode Island | 02886 | — |
| Research Site | Anderson | South Carolina | 29621 | — |
| Research Site | Clinton | South Carolina | 29325 | — |
| Research Site | Columbia | South Carolina | 29203 | — |
| Research Site | Gaffney | South Carolina | 29341 | — |
| Research Site | Greenville | South Carolina | 29607 | — |
| Research Site | Mt. Pleasant | South Carolina | 29464 | — |
| Research Site | Myrtle Beach | South Carolina | 29588 | — |
| Research Site | North Charleston | South Carolina | 29420 | — |
| Research Site | Pelzer | South Carolina | 29669 | — |
| Research Site | Rock Hill | South Carolina | 29732 | — |
| Research Site | Spartanburg | South Carolina | 29303 | — |
| Research Site | Austin | Texas | 78726 | — |
| Research Site | Austin | Texas | 78759 | — |
| Research Site | Beaumont | Texas | 77702 | — |
| Research Site | Boerne | Texas | 78006 | — |
| Research Site | Conroe | Texas | 77384 | — |
| Research Site | Corsicana | Texas | 75110 | — |
| Research Site | Dallas | Texas | 75225 | — |
| Research Site | Dallas | Texas | 75231 | — |
| Research Site | Dallas | Texas | 75246 | — |
| Research Site | El Paso | Texas | 79903 | — |
| Research Site | Galveston | Texas | 77555 | — |
| Research Site | Houston | Texas | 77036 | — |
| Research Site | Kerrville | Texas | 78028 | — |
| Research Site | Live Oak | Texas | 78233 | — |
| Research Site | McKinney | Texas | 75069 | — |
| Research Site | Pearland | Texas | 77584 | — |
| Research Site | San Antonio | Texas | 78229 | — |
| Research Site | San Antonio | Texas | 78230 | — |
| Research Site | Sherman | Texas | 75092 | — |
| Research Site | The Woodlands | Texas | 77380 | — |
| Research Site | Tomball | Texas | 77375 | — |
| Research Site | Waco | Texas | 76712 | — |
| Research Site | Waxahachie | Texas | 75165 | — |
| Research Site | Murray | Utah | 84107 | — |
| Research Site | Salt Lake City | Utah | 84107 | — |
| Research Site | South Burlington | Vermont | 05403 | — |
| Research Site | Morgantown | West Virginia | 26505 | — |
| Research Site | 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 175 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03769090, 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 Sep 28, 2022 · Synced Oct 21, 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 NCT03769090 live on ClinicalTrials.gov.