At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 80 enrolled
Drug / intervention
GFF MDI (PT003) +2 moredrug
Likely dose
Not stated in 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.
A Randomized, Phase IIIb, Three-period, Three-treatment, Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects With Moderate to Very Severe COPD After 4 Weeks of Treatment With PT003, Open-Label Spiriva® Respimat® (Tiotropium Bromide) as an Active Control, and Placebo
In Brief
A Phase 3 clinical trial evaluating GFF MDI (PT003), Placebo MDI, and 1 other intervention for COPD. Completed, enrolled 80 participants.
Detailed Summary
Randomized, Phase IIIb, Three-period, Three-treatment, Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe COPD after 4 Weeks of Treatment with PT003, Open-Label Spiriva® Respimat® (Tiotropium Bromide) as an Active Control, and Placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 2015
Enrollment StartFeb 2015
Primary CompletionAug 2015
Study CompletionMar 2016
TodayJul 2026
First PostedJan 27, 2015
Enrollment StartFeb 1, 2015
Primary CompletionAug 1, 2015
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 11.4 years ago
Interventions
GFF MDI (PT003)drug
Placebo MDIdrug
Spiriva® Respimat® (Tiotropium Bromide)drug
Tiotropium Bromide Inhalation Solution; Spiriva® Respimat® (Spiriva)