CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 180 enrolled
Drug / intervention
BFF MDI 320/9.6 μg +4 moredrug
Likely dose
BFF MDI 320/9.6 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/NCT02196077
NCT02196077Phase 2Completed
CompareCT.gov

A Randomized, Double Blind, Chronic Dosing (28 Days), Four Period, Five Treatment, Incomplete Block, Multi Center, Crossover Study to Assess the Efficacy and Safety of PT009, PT008, and PT005 in Subjects With Moderate to Severe COPD

Pearl Therapeutics, Inc.·interventional·Posted Jul 21, 2014·Updated Jun 20, 2018

In Brief

A Phase 2 clinical trial evaluating BFF MDI 320/9.6 μg, BFF MDI 160/9.6 μg, and 3 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 180 participants across 17 sites.

Detailed Summary

This is a Phase IIb, randomized, double blind, chronic dosing (28 days), four period, five treatment, incomplete block, crossover design in subjects with moderate to severe COPD. The overall objective is to demonstrate that the combination of budesonide (BD; PT008) and formoterol fumarate (FF; PT005) in a metered-dose inhaler (MDI); (BFF MDI; PT009) provides benefit on lung function compared with BD MDI in subjects with moderate to severe COPD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 21, 2014
Enrollment StartAug 1, 2014
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.9 years ago

Interventions

BFF MDI 320/9.6 μgdrug

Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 320/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)

BFF MDI 160/9.6 μgdrug

Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 160/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)

BFF MDI 80/9.6 μgdrug

Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 80/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)

BD MDI 320 μgdrug

Budesonide metered dose inhaler (BD MDI) 320 μg; PT008 administered as 2 inhalations, twice daily (BID)

FF MDI 9.6 μgdrug

Formoterol fumarate metered dose inhaler (FF MDI) 9.6 μg; PT005 administered as 2 inhalations, twice daily (BID)