Asthma study: BDA MDI vs AS MDI
Official title Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma
ClinicalTrials.gov ID: NCT06307665
What this study is testing
What is BDA MDI?
An investigational inhaled medication being studied for asthma in adolescents.
Also referred to as budesonide/albuterol.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study compares how often severe asthma flare‑ups happen each year when teens use a budesonide/albuterol inhaler versus when they use albuterol alone, both taken only when needed.
- Who it's for
- Teens aged 12 to 17 who have been diagnosed with asthma and have had at least one severe flare‑up in the past year.
- What's involved
- Participants will use one of two inhalers as needed for asthma symptoms and will keep records of flare‑ups and any side effects. They may have routine check‑ups and tests to monitor asthma control.
- Time commitment
- The study lasts about one year, with regular visits to the clinic to review symptoms, record flare‑ups, and check for side effects.
- Phase 3: a large, late-stage study
- Time commitment: about 52 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 17
You may be able to join if
- Confirmed clinical diagnosis of asthma at least 12 months.
- Receiving one of the following scheduled asthma maintenance therapies for at least 3 months with stable dosing for at least the last one month
- Low-to-high-dose Inhaled corticosteroid(s) (ICS)
- Low-to-high-dose ICS or ICS/long-acting β2-agonist (LABA) with or without one additional maintenance therapy from the following: leukotriene receptor...
- Receiving inhaled short-acting β2-agonist (SABA) as needed.
You likely can't join if
- Life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest...
- Experienced \> 3 severe asthma exacerbations within 12 months before screening.
- Completed treatment for lower respiratory infection and severe asthma exacerbation with SCS within 4 weeks of screening.
- Upper respiratory infection involving antibiotic treatment not resolved.
- Current smokers, former smokers with \> 10 pack-years history, or former smokers who stopped smoking \< 6 months (including all forms of tobacco...
- Other significant lung disease, including regular or occasional use of oxygen.
See the full eligibility criteria
- Confirmed clinical diagnosis of asthma at least 12 months.
- Receiving one of the following scheduled asthma maintenance therapies for at least 3 months with stable dosing for at least the last one month
- Low-to-high-dose Inhaled corticosteroid(s) (ICS)
- Low-to-high-dose ICS or ICS/long-acting β2-agonist (LABA) with or without one additional maintenance therapy from the following: leukotriene receptor antagonist (LTRA), long-acting muscarinic antagonist (LAMA), or...
- Receiving inhaled short-acting β2-agonist (SABA) as needed.
- A documented history of at least one severe asthma exacerbation within 12 months.
- Use of Sponsor-provided albuterol sulfate inhalation aerosol medication.
- Demonstrate acceptable MDI administration technique as assessed by the investigator; use of spacers is prohibited.
- Able to perform acceptable and reproducible peak expiratory flow (PEF) measurements as assessed by the investigator.
- Participants must adhere to protocol specific contraception methods.
- Negative urine pregnancy test for participants of childbearing potential.
- Have a BMI \< 40 kg/ m\^2.
- Capable of giving assent (signing the assent form) to participate in the study which includes compliance with the requirements and restrictions.
- Life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).
- Experienced \> 3 severe asthma exacerbations within 12 months before screening.
- Completed treatment for lower respiratory infection and severe asthma exacerbation with SCS within 4 weeks of screening.
- Upper respiratory infection involving antibiotic treatment not resolved.
- Current smokers, former smokers with \> 10 pack-years history, or former smokers who stopped smoking \< 6 months (including all forms of tobacco, e-cigarettes [vaping], and marijuana).
- Other significant lung disease, including regular or occasional use of oxygen.
- Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neuropsychological, endocrine, or gastrointestinal disorders.
- Cancer not in complete remission for at least 5 years.
- History or hospitalization for psychiatric disorder or attempted suicide within one year.
- Significant abuse of alcohol or drugs, in the opinion of the investigator.
- Oral corticosteroid(s) (OCS)/SCS use (any dose and any indication) within 4 weeks before Visit 1 or chronic use of OCS/SCS (≥ 3 weeks use in 3 months prior to Visit 1).
- Use of any oral SABAs within one month.
- Having a known or suspected hypersensitivity to albuterol/salbutamol, or budesonide and/or their excipients.
The study team makes the final eligibility decision.
Where it is enrolling
- Anchorage, Alaska, United States
- Gilbert, Arizona, United States
- Phoenix, Arizona, United States
- Long Beach, California, United States
- Mission Viejo, California, United States
- Moreno Valley, California, United States
- Orange, California, United States
- Redondo Beach, California, United States
- Riverside, California, United States
- San Diego, California, United States
- Westminster, California, United States
- Denver, Colorado, United States
- Wilmington, Delaware, United States
- Destin, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Pembroke Pines, Florida, United States
- Atlanta, Georgia, United States
- Columbus, Georgia, United States
- Fayetteville, Georgia, United States
+ 77 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Anchorage, Alaska, United States; Gilbert, Arizona, United States; Phoenix, Arizona, United States; Long Beach, California, United States; Mission Viejo, California, United States; Moreno Valley, California, United States and 91 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.