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NCT03371459 · ClinicalTrials.gov registry record · Phase 2

Assessment of the Safety, Efficacy, PK, and Extrapulmonary Pharmacodynamics (PD) of Albuterol Sulfate Pressurized Inhalation Suspension (Hereafter Referred to as AS MDI) Compared to Proventil as an Active Control in Subjects With Asthma

A Phase 2 study of Asthma, sponsored by AstraZeneca.

Completed
Registry status
Phase 2
Development phase
46
Enrollment target
5
Study locations

NCT03371459 is a Phase 2 study of Asthma that has completed, run by AstraZeneca. The registered enrollment target is 46 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (97% lower). The trial reports 5 study locations across 5 states.

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The verdict

NCT03371459, a Phase 2 study of Asthma, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 2
Development phase
46 participants
Enrollment target
5
Study locations

Study Summary

This is a randomized, cumulative dose, open-label, 2-period crossover, multi-center study to assess the safety, efficacy, PK, and extrapulmonary PD of cumulative doses of AS MDI compared to cumulative doses of Proventil as an active control in subjects with mild to moderate asthma

Conditions Studied

Interventions

  • DRUG AS MDI
  • DRUG Proventil

Study Locations (5)

Florida

  • Research Site - Winter Park

Massachusetts

  • Research Site - North Dartmouth

Missouri

  • Research Site - St Louis

North Carolina

  • Research Site - Raleigh

Oregon

  • Research Site - Medford

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2017-12-29
Est. Completion 2018-03-26
Phase Phase 2

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT03371459

The ClinicalTrials.gov registry entry for NCT03371459 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (97% 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 AS MDI is the first listed.

NCT03371459 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Florida, Massachusetts, Missouri.

Frequently Asked Questions

What is clinical trial NCT03371459 about?

NCT03371459 is a clinical study titled "Assessment of the Safety, Efficacy, PK, and Extrapulmonary Pharmacodynamics (PD) of Albuterol Sulfate Pressurized Inhalation Suspension (Hereafter Referred to as AS MDI) Compared to Proventil as an Active Control in Subjects With Asthma". This is a randomized, cumulative dose, open-label, 2-period crossover, multi-center study to assess the safety, efficacy, PK, and extrapulmonary PD of cumulative doses of AS MDI compared to cumulative doses of Proventil as an active control in subjects with mild to moderate asthma

What is the current status of trial NCT03371459?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2017-12-29. Estimated completion is 2018-03-26.

What conditions does trial NCT03371459 study?

This clinical trial studies the following conditions: Asthma.

What interventions are being tested in trial NCT03371459?

The interventions under investigation include: AS MDI (DRUG), Proventil (DRUG).

Who is sponsoring clinical trial NCT03371459?

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

Where is trial NCT03371459 being conducted?

This trial has 5 study locations across Florida, Massachusetts, Missouri, North Carolina, Oregon. 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

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.