Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma
Condition(s) studied
Investigational drug(s) / intervention(s)
BDA MDI: Participants will receive oral inhalation of BDA MDI 160/180 μg taken as 2 puffs of 80/90 μg as needed.
AS MDI: Participants will receive oral inhalation of AS MDI 180 μg taken as 2 puffs of 90 μg as needed.
Study summary
The purpose of this study is to compare the effect of budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI), both administered as needed, on the annualized rate of severe asthma exacerbations in adolescents with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year.
Eligibility
Primary outcome measure(s)
- Annualized rate of severe asthma exacerbations (AAER) — From Randomization (Day 1) to Week 52 (EOT)
The effect of BDA MDI compared with AS MDI, both administered as needed, on the AAER in participants with asthma will be evaluated.
Trial sites (155)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Anchorage | Alaska | Recruiting |
| Research Site | Gilbert | Arizona | Recruiting |
| Research Site | Phoenix | Arizona | Recruiting |
| Research Site | Little Rock | Arkansas | Completed |
| Research Site | Huntington Beach | California | Not Yet Recruiting |
| Research Site | Huntington Beach | California | Not Yet Recruiting |
| Research Site | Long Beach | California | Recruiting |
| Research Site | Long Beach | California | Recruiting |
| Research Site | Madera | California | Not Yet Recruiting |
| Research Site | Mission Viejo | California | Recruiting |
| Research Site | Moreno Valley | California | Recruiting |
| Research Site | Orange | California | Recruiting |
| Research Site | Redondo Beach | California | Not Yet Recruiting |
| Research Site | Riverside | California | Recruiting |
| Research Site | San Diego | California | Recruiting |
| Research Site | San Diego | California | Not Yet Recruiting |
| Research Site | San Francisco | California | Withdrawn |
| Research Site | Westminster | California | Recruiting |
| Research Site | Denver | Colorado | Recruiting |
| Research Site | Wilmington | Delaware | Recruiting |
| Research Site | Destin | Florida | Recruiting |
| Research Site | Jacksonville | Florida | Recruiting |
| Research Site | Kendall | Florida | Not Yet Recruiting |
| Research Site | Largo | Florida | Completed |
| Research Site | Miami | Florida | Recruiting |
| Research Site | Miami | Florida | Recruiting |
| Research Site | Miami | Florida | Recruiting |
| Research Site | Miami | Florida | Not Yet Recruiting |
| Research Site | Miami | Florida | Recruiting |
| Research Site | Orlando | Florida | Not Yet Recruiting |
| Research Site | Pembroke Pines | Florida | Recruiting |
| Research Site | Tampa | Florida | Withdrawn |
| Research Site | Atlanta | Georgia | Recruiting |
| Research Site | Columbus | Georgia | Recruiting |
| Research Site | Fayetteville | Georgia | Recruiting |
| Research Site | Snellville | Georgia | Recruiting |
| Research Site | Meridian | Idaho | Withdrawn |
| Research Site | Normal | Illinois | Recruiting |
| Research Site | River Forest | Illinois | Withdrawn |
| Research Site | Indianapolis | Indiana | Recruiting |
+ 115 more sites — see the full list on the official registry below.
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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 NCT06307665 on ClinicalTrials.gov ↗ ← All trials in the USA