NCT02105012

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

Randomized, Double-Blind, Chronic Dosing (4 Weeks), Four-Period, Five-Treatment, Incomplete Block, Cross-Over, Multi-Center 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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Pearl Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, double-blind, chronic dosing (4 weeks), four-period, five-treatment, incomplete block, cross-over, multicenter 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

• Asthma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-09-01
• Completion: 2015-09-04
• First posted: 2014-04-07
• Last updated: 2017-06-06
• Results posted: 2017-06-06

Locations

41 sites across 1 country: United States

Regulatory

• FDA-regulated drug study