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Study to Assess Bronchospasm Potentially Induced by HFO vs HFA MDI in Participants With Well/Partially Controlled Asthma
Phase 3
Waitlist Available
Led By David Miller, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 days
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
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.
Eligible Conditions
- Asthma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline FEV1 to 15-min post-dose
Secondary study objectives
Cumulative incidence of bronchospasm events
Safety and tolerability will be evaluated in terms of AEs
Other study objectives
Repeated measurements of change from baseline in FEV1 at 5, 15, and 30 minutes post-dose during each treatment period
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment A: HFO propellant only MDIExperimental Treatment1 Intervention
Test arm, 4 inhalations per dose
Group II: Treatment B: HFA propellant only MDIActive Control1 Intervention
Reference arm, 4 inhalations per dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HFO MDI
2023
Completed Phase 3
~90
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,411 Previous Clinical Trials
289,123,541 Total Patients Enrolled
348 Trials studying Asthma
656,693 Patients Enrolled for Asthma
David Miller, MDPrincipal InvestigatorNortheast Medical Research Associates, Inc.
3 Previous Clinical Trials
106 Total Patients Enrolled
Craig LaForce, MDPrincipal InvestigatorNorth Carolina Clinical Research
2 Previous Clinical Trials
558 Total Patients Enrolled
1 Trials studying Asthma
408 Patients Enrolled for Asthma
Allen T Funkhouser, MCPrincipal InvestigatorEPIMRD Inc.
Jeffrey Tillinghast, MDPrincipal InvestigatorThe Clinical Research Center, LLC.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Treatment A: HFO propellant only MDI
- Group 2: Treatment B: HFA propellant only MDI
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.