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A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered Dose Inhaler (BDA MDI/PT027) Used 4 Times Daily in Adults and Children 4 Years of Age or Older With Asthma

NCT03847896 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1001

Last updated 2023-04-13

Study results available
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Summary

This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study to compare 2 dose levels of budesonide/albuterol BDA MDI (PT027) to its components budesonide BD MDI (PT008) and albuterol AS MDI (PT007) on improvement in lung function and asthma symptoms after 12 weeks of treatment in adult, adolescent, and child subjects with symptomatic asthma currently being treated with a short/rapid-acting β2-adrenoreceptor agonist (SABA) as needed alone or with low-dose inhaled corticosteroid (ICS) maintenance therapy plus SABA as needed.

Conditions

Interventions

COMBINATION_PRODUCT

Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose)

Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 160/180 micrograms (μg), given as 2 inhalations of BDA MDI 80/90 μg, four times a day (QID)

COMBINATION_PRODUCT

Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose)

Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 80/180 micrograms (μg), given as 2 inhalations of BDA MDI 40/90 μg, four times a day (QID)

DRUG

Budesonide metered dose inhaler / BD MDI 160 µg

Budesonide pressurized metered dose inhaler (BD MDI) 160 micrograms (μg), given as 2 inhalations of BD MDI 80 μg, four times a day (QID)

DRUG

Albuterol sulfate metered dose inhaler / AS MDI 180 μg

Albuterol sulfate pressurized metered dose inhaler (AS MDI) 180 micrograms (μg), given as 2 inhalations of AS MDI 90 μg, four times a day (QID)

OTHER

Placebo metered-dose inhaler / Placebo MDI

Placebo pressurized metered dose inhaler (Placebo MDI), given as 2 inhalations of Placebo MDI, four times a day (QID)

Sponsors & Collaborators

  • Bond Avillion 2 Development LP

    lead INDUSTRY

Principal Investigators

  • Frank Albers, MD, PhD · Avillion LLP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-20
Primary Completion
2021-07-20
Completion
2021-07-20
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Czechia
  • Germany
  • Serbia
  • Slovakia
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03847896 on ClinicalTrials.gov