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Study to Assess the Efficacy and Safety of Budesonide (PT008) in Adult Subjects With Mild to Moderate Persistent Asthma

NCT02105012 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2017-06-06

Study results available
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Summary

Study to assess the efficacy and safety of four doses of budesonide inhalation aerosol (BD MDI, PT008) relative to placebo MDI in adult subjects with mild to moderate persistent asthma.

Conditions

Interventions

DRUG

BD MDI 320 µg

Budesonide Inhalation Aerosol administered as 2 inhalations BID

DRUG

BD MDI 160 µg

Budesonide Inhalation Aerosol administered as 2 inhalations BID

DRUG

BD MDI 80 µg

Budesonide Inhalation Aerosol administered as 2 inhalations BID

DRUG

BD MDI 40 µg

Budesonide Inhalation Aerosol administered as 2 inhalations BID

DRUG

Placebo MDI

Placebo MDI administered as 2 inhalations BID

Sponsors & Collaborators

  • Pearl Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Dorinsky, MD, FCCP · Pearl Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-01
Primary Completion
2015-09-01
Completion
2015-09-04
FDA Drug
Yes

Countries

  • United States

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 NCT02105012 on ClinicalTrials.gov