RecruitingAsthma

Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma

Eligible age

12–17 yrs

Accepts

All genders

Locations

36 states

Healthy volunteers

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About this study

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.

Sponsor: AstraZeneca

You may qualify 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
✓ 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.

You may not qualify if…

✕ 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.