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NCT04234464 · ClinicalTrials.gov registry record · Phase 3

A Study to Assess the Efficacy of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) on Exercise-induced Bronchoconstriction in Adults and Adolescents With Asthma

A Phase 3 study, sponsored by Bond Avillion 2 Development.

Completed
Registry status
Phase 3
Development phase
60
Enrollment target

NCT04234464: Completed Phase 3 study, sponsored by Bond Avillion 2 Development.

NCT04234464 is a Phase 3 study that has completed, run by Bond Avillion 2 Development. The registered enrollment target is 60 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04234464, a Phase 3 study, has completed, sponsored by Bond Avillion 2 Development.

COMPLETED
Registry status
Phase 3
Development phase
60 participants
Enrollment target

Study Summary

This is a multicenter, randomized, double-blind, single-dose, placebo-controlled, 2-period, crossover study to evaluate the efficacy and safety of budesonide/albuterol metered-dose inhaler (BDA MDI/PT027) as compared with a placebo metered-dose inhaler (placebo MDI) on exercise-induced bronchoconstriction (EIB) in adult and adolescent subjects with asthma. Subjects will receive each study treatment on separate visits and undergo a treadmill exercise challenge test for up to 10 minutes so that the effect of study treatment on exercise-induced bronchoconstriction can be evaluated.

Interventions

  • COMBINATION_PRODUCT Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg
  • COMBINATION_PRODUCT Placebo metered-dose inhaler

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2020-01-15
Est. Completion 2020-08-28
Phase Phase 3

Sponsor

Bond Avillion 2 Development

6 total trials

What the Registry Record Tells You About NCT04234464

The ClinicalTrials.gov registry entry for NCT04234464 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bond Avillion 2 Development, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg is the first listed.

NCT04234464 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04234464 about?

NCT04234464 is a clinical study titled "A Study to Assess the Efficacy of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) on Exercise-induced Bronchoconstriction in Adults and Adolescents With Asthma". This is a multicenter, randomized, double-blind, single-dose, placebo-controlled, 2-period, crossover study to evaluate the efficacy and safety of budesonide/albuterol metered-dose inhaler (BDA MDI/PT027) as compared with a placebo metered-dose inhaler (placebo MDI) on exercise-induced bronchoconstr...

What is the current status of trial NCT04234464?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2020-01-15. Estimated completion is 2020-08-28.

What interventions are being tested in trial NCT04234464?

The interventions under investigation include: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg (COMBINATION_PRODUCT), Placebo metered-dose inhaler (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT04234464?

This trial is sponsored by Bond Avillion 2 Development, which has 6 total clinical trials registered on ClinicalTrials.gov.

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, the data changelog, or report a data error.