Study to Assess Bronchospasm Potentially Induced by HFO vs HFA MDI in Participants With Well/Partially Controlled Asthma

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byDavid Miller, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is studying if one type of inhaler causes more breathing problems than another in adults aged 18-45 with asthma. The inhalers help improve breathing by reducing airway tightness.

Eligibility Criteria

Inclusion Criteria

Male and female participant must be 18 to 45 years of age inclusive, at the time of signing the informed consent form (ICF).

Participants who have a documented history of physician-diagnosed asthma ≥ 12 months prior to Visit 1, according to GINA guidelines (GINA 2022).

Participants who are well controlled or partially controlled on their current treatment for asthma, including, low-dose ICS daily or low-dose ICS/formoterol as needed (not approved in the US), or SABA as needed, or low-dose ICS whenever SABA as needed is used (low-dose ICS as defined by GINA 2022 in Table 4), for 4 weeks prior to screening.

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Exclusion Criteria

Study investigators, sub-investigators, coordinators, and their employees or immediate family members.

Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s).

Current smokers, former smokers with > 10 pack-years history, or former smokers who stopped smoking < 6 months prior to Visit 1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana).

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