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Treatment A: HFO propellant only MDI for 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 weeks
Treatment ~ Varies
Follow Up ~up to 36 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 days for reporting.

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
4,397 Previous Clinical Trials
289,121,604 Total Patients Enrolled
347 Trials studying Asthma
661,417 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

Media Library

HFA MDI (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05850494 — Phase 3
Asthma Research Study Groups: Treatment A: HFO propellant only MDI, Treatment B: HFA propellant only MDI
Asthma Clinical Trial 2023: HFA MDI Highlights & Side Effects. Trial Name: NCT05850494 — Phase 3
HFA MDI (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05850494 — Phase 3
~21 spots leftby Nov 2025
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