A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered Dose Inhaler (BDA MDI/PT027) Used 4 Times Daily in Adults and Children 4 Years of Age or Older With Asthma
Public ClinicalTrials.gov record NCT03847896. 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 12-week, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT008 and PT007 Administered QID in 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, placebo-controlled, multicenter, parallel group study to compare 2 dose levels of budesonide/albuterol BDA MDI (PT027) to its components budesonide BD MDI (PT008) and albuterol AS MDI (PT007) on improvement in lung function and asthma symptoms after 12 weeks of treatment in adult, adolescent, and child subjects with symptomatic asthma currently being treated with a short/rapid-acting β2-adrenoreceptor agonist (SABA) as needed alone or with low-dose inhaled corticosteroid (ICS) maintenance therapy plus SABA as needed.
Study identification
- NCT ID
- NCT03847896
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,001 participants
Conditions and interventions
Conditions
Interventions
- Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose) Combination Product
- Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose) Combination Product
- Budesonide metered dose inhaler / BD MDI 160 µg Drug
- Albuterol sulfate metered dose inhaler / AS MDI 180 μg Drug
- Placebo metered-dose inhaler / Placebo MDI Other
Combination Product · Drug · Other
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
- Mar 20, 2019 (Actual)
- Primary completion
- Jul 20, 2021 (Actual)
- Completion
- Jul 20, 2021 (Actual)
- Last update posted
- Apr 13, 2023
2019 – 2021
United States locations
- U.S. sites
- 73
- U.S. states
- 26
- U.S. cities
- 63
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Mobile | Alabama | 36608 | — |
| Research Site | Bakersfield | California | 93301 | — |
| Research Site | Costa Mesa | California | 92627 | — |
| Research Site | Encinitas | California | 92024 | — |
| Research Site | Huntington Beach | California | 92647 | — |
| Research Site | Lancaster | California | 93534 | — |
| Research Site | Los Angeles | California | 90017 | — |
| Research Site | Los Angeles | California | 90048 | — |
| Research Site | Newport Beach | California | 92663 | — |
| Research Site | Roseville | California | 95661 | — |
| Research Site | Sacramento | California | 95823 | — |
| Research Site | San Diego | California | 92123 | — |
| Research Site | San Jose | California | 95117 | — |
| Research Site | Waterbury | Connecticut | 06708 | — |
| Research Site | Aventura | Florida | 33180 | — |
| Research Site | Clearwater | Florida | 33765 | — |
| Research Site | Gainesville | Florida | 32653 | — |
| Research Site | Greenacres City | Florida | 33467 | — |
| Research Site | Miami | Florida | 33126 | — |
| Research Site | Miami | Florida | 33173 | — |
| Research Site | Miami | Florida | 33174 | — |
| Research Site | Miami | Florida | 33186 | — |
| Research Site | Orlando | Florida | 32819 | — |
| Research Site | Oviedo | Florida | 32765 | — |
| Research Site | Palmetto Bay | Florida | 33157 | — |
| Research Site | Pembroke Pines | Florida | 33024 | — |
| Research Site | Pembroke Pines | Florida | 33026 | — |
| Research Site | Meridian | Idaho | 83646 | — |
| Research Site | Chicago | Illinois | 60602 | — |
| Research Site | Chicago | Illinois | 60644 | — |
| Research Site | White Marsh | Maryland | 21162 | — |
| Research Site | Boston | Massachusetts | 02115 | — |
| Research Site | North Dartmouth | Massachusetts | 02747 | — |
| Research Site | Farmington Hills | Michigan | 48336 | — |
| Research Site | Flint | Michigan | 48507 | — |
| Research Site | Rochester Hills | Michigan | 48307 | — |
| Research Site | Woodbury | Minnesota | 55125 | — |
| Research Site | Columbia | Missouri | 65203 | — |
| Research Site | Rolla | Missouri | 65401 | — |
| Research Site | St Louis | Missouri | 63141 | — |
| Research Site | Warrensburg | Missouri | 64093 | — |
| Research Site | Missoula | Montana | 59808 | — |
| Research Site | Bellevue | Nebraska | 68005 | — |
| Research Site | Bellevue | Nebraska | 68123 | — |
| Research Site | Las Vegas | Nevada | 89106 | — |
| Research Site | Las Vegas | Nevada | 89119 | — |
| Research Site | Skillman | New Jersey | 08558 | — |
| Research Site | Toms River | New Jersey | 08755 | — |
| Research Site | New Hyde Park | New York | 11040 | — |
| Research Site | New York | New York | 10036 | — |
| Research Site | The Bronx | New York | 10461 | — |
| Research Site | Monroe | North Carolina | 28112 | — |
| Research Site | Raleigh | North Carolina | 27607 | — |
| Research Site | Oklahoma City | Oklahoma | 73106 | — |
| Research Site | Oklahoma City | Oklahoma | 73112 | — |
| Research Site | Tulsa | Oklahoma | 74136 | — |
| Research Site | Medford | Oregon | 97504 | — |
| Research Site | Portland | Oregon | 97202 | — |
| Research Site | Erie | Pennsylvania | 16508 | — |
| Research Site | Warwick | Rhode Island | 02886 | — |
| Research Site | Gaffney | South Carolina | 29341 | — |
| Research Site | Spartanburg | South Carolina | 29303 | — |
| Research Site | Knoxville | Tennessee | 37909 | — |
| Research Site | Austin | Texas | 78759 | — |
| Research Site | Boerne | Texas | 78006 | — |
| Research Site | Corsicana | Texas | 75110 | — |
| Research Site | Dallas | Texas | 75225 | — |
| Research Site | El Paso | Texas | 79903 | — |
| Research Site | San Antonio | Texas | 78207 | — |
| Research Site | San Antonio | Texas | 78229 | — |
| Research Site | Sherman | Texas | 75092 | — |
| 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 56 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03847896, 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 Apr 13, 2023 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03847896 live on ClinicalTrials.gov.