NCT06307665 Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma
| NCT ID | NCT06307665 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | AstraZeneca |
| Condition | Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 440 participants |
| Start Date | 2024-05-20 |
| Primary Completion | 2027-10-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 440 participants in total. It began in 2024-05-20 with a primary completion date of 2027-10-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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-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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06307665 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06307665 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 440 participants.
Is NCT06307665 currently recruiting?
Yes, NCT06307665 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT06307665 trial being conducted?
This trial is being conducted at Anchorage, United States, Gilbert, United States, Phoenix, United States, Little Rock, United States and 11 additional locations.
Who is sponsoring the NCT06307665 clinical trial?
NCT06307665 is sponsored by AstraZeneca. The trial plans to enroll 440 participants.
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