Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma
Recruiting
Phase 3Interventional Study
Asthma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
12 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
440 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
This trial is looking for adolescents aged 12 to 17 with asthma. Participants will compare two treatments for asthma that are used when needed to see which is more effective and safe.
Are You a Good Fit for This Trial?
Rules you outSerious lung diseaseCancer not in remissionPsychiatric disorderSubstance abuse
You may be able to join if
I have been diagnosed with asthma for at least 12 months.
I have had at least one severe asthma attack in the past year.
I am currently receiving asthma maintenance therapy.
I use a rescue inhaler as needed.
I can take my medication correctly as verified by a doctor.
I can do expected lung function tests.
I can agree to participate in the study.
I have a negative pregnancy test if I can get pregnant.
You may not be able to join if
I have had a severe asthma episode that required intubation.
I have had more than 3 severe asthma attacks in the last year.
I have had a serious lung infection within the last 4 weeks.
I have not fully recovered from an upper respiratory infection.
I currently smoke or have smoked heavily in the past.
I have another serious lung disease.
I have a significant health issue like cancer or a psychiatric disorder.
I have taken oral steroids for asthma in the last month.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion 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
1. Low-to-high-dose Inhaled corticosteroid(s) (ICS)
2. Low-to-high-d…
Inclusion 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
1. Low-to-high-dose Inhaled corticosteroid(s) (ICS)
2. 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 theophylline
* 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. The caregiver of the patient must be capable of giving written informed consent for the patient's participation in the study. Consent and assent forms must be completed prior to any study-specific procedures.
Exclusion Criteria:
* 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.
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