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NCT06307665 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Asthma, sponsored by AstraZeneca.

Recruiting
Registry status
Phase 3
Development phase
440
Enrollment target
20
Study locations

NCT06307665 is a Phase 3 study of Asthma that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 440 participants, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT06307665, a Phase 3 study of Asthma, is actively recruiting participants, sponsored by AstraZeneca.

RECRUITING
Registry status
Phase 3
Development phase
440 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Asthma

Interventions

  • COMBINATION_PRODUCT BDA MDI
  • COMBINATION_PRODUCT AS MDI

Study Locations (20)

California

  • Research Site - Long Beach
  • Research Site - Long Beach
  • Research Site - Madera
  • Research Site - Mission Viejo
  • Research Site - Moreno Valley
  • Research Site - Orange
  • Research Site - Riverside
  • Research Site - San Diego
  • Research Site - San Diego
  • Research Site - San Francisco
  • Research Site - Westminster

Florida

  • Research Site - Destin
  • Research Site - Jacksonville
  • Research Site - Largo

Arizona

  • Research Site - Gilbert
  • Research Site - Phoenix

Alaska

  • Research Site - Anchorage

Arkansas

  • Research Site - Little Rock

Colorado

  • Research Site - Denver

Delaware

  • Research Site - Wilmington

Trial Details

FieldValue
Enrollment Target 440 participants
Start Date 2024-05-20
Est. Completion 2027-10-13
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06307665

The ClinicalTrials.gov registry entry for NCT06307665 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 440 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (72% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which BDA MDI is the first listed.

NCT06307665 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT06307665 about?

NCT06307665 is a clinical study titled "Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma". 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 as...

What is the current status of trial NCT06307665?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 440 participants. The study started on 2024-05-20. Estimated completion is 2027-10-13.

What conditions does trial NCT06307665 study?

This clinical trial studies the following conditions: Asthma.

What interventions are being tested in trial NCT06307665?

The interventions under investigation include: BDA MDI (COMBINATION_PRODUCT), AS MDI (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT06307665?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06307665 being conducted?

This trial has 20 study locations across Alaska, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.