CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 20 enrolled
Drug / intervention
GFF MDI (PT003) 14.4/9.6μg +1 moredrug
Likely dose
PT003 (Glycopyrronium/Formoterol Fumarate) 14.4/9.6 μg MDIAI-extracted
Key inclusion· 4
  • ✓Established clinical history of COPD meeting ATS/ERS criteria
  • ✓Current or former smoker with ≥10 pack-year history
  • ✓FEV1/FVC ratio <0.70 at screening
  • ✓Post-bronchodilator FEV1 30-80% of predicted normal (NHANES III) with FEV1/FVC <70%
Key exclusion· 6
  • ✕Current diagnosis of asthma
  • ✕Hospitalization for poorly controlled COPD within 3 months prior to screening or during run-in period
  • ✕Acute COPD exacerbation requiring oral corticosteroids or antibiotics within 6 weeks prior to screening or during run-in
  • ✕Diagnosed angle closure glaucoma (treated or untreated)

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

Search/NCT02643082
NCT02643082Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Two Treatment, Two Period, Chronic Dosing (2 Weeks), Cross-Over, Single-Center Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD

Pearl Therapeutics, Inc.·interventional·Posted Dec 30, 2015·Updated Mar 19, 2019

In Brief

A Phase 3 clinical trial evaluating GFF MDI (PT003) 14.4/9.6μg and Placebo MDI for COPD. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance With Moderate to Severe COPD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesBelgium
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 30, 2015
Enrollment StartDec 23, 2015
Primary CompletionJan 26, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 10.5 years ago

Interventions

GFF MDI (PT003) 14.4/9.6μgdrug

Glycopyrronium and Formoterol Fumarate

Placebo MDIdrug

Comparator: Placebo MDI which contains no active ingredients