CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 147 enrolled
Drug / intervention
BD MDI 320 µg +4 moredrug
Likely dose
BD MDI 320 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02105012
NCT02105012Phase 2Completed
CompareCT.gov

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

Pearl Therapeutics, Inc.·interventional·Posted Apr 7, 2014·Updated Jun 6, 2017

In Brief

A Phase 2 clinical trial evaluating BD MDI 320 µg, BD MDI 160 µg, and 3 other interventions for Asthma. Completed, enrolled 147 participants across 41 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 7, 2014
Enrollment StartApr 1, 2014
Primary CompletionSep 1, 2015
Study CompletionSep 4, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.2 years ago

Interventions

BD MDI 320 µgdrug

Budesonide Inhalation Aerosol administered as 2 inhalations BID

BD MDI 160 µgdrug

Budesonide Inhalation Aerosol administered as 2 inhalations BID

BD MDI 80 µgdrug

Budesonide Inhalation Aerosol administered as 2 inhalations BID

BD MDI 40 µgdrug

Budesonide Inhalation Aerosol administered as 2 inhalations BID

Placebo MDIdrug

Placebo MDI administered as 2 inhalations BID