NCT02454959

Crossover Study to Assess the Efficacy of PT003 With and Without a Valved Holding Chamber in Subjects With Moderate to Severe COPD

Completed Phase 3 Results posted Last updated 19 April 2017

What this trial tests

Phase 3 trial testing GFF MDI (PT003) with Aerochamber in COPD in 80 participants. Completed in 25 March 2016.

Timeline

1 May 2015

Primary endpoint
25 March 2016

25 March 2016

Quick facts

Lead sponsor	Pearl Therapeutics, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	1 May 2015
Primary completion	25 March 2016
Estimated completion	25 March 2016
Sites	6 locations across United States

Drugs / interventions tested

• GFF MDI (PT003) with Aerochamber
• GFF MDI (PT003) without Aerochamber

Conditions studied

• COPD — all drugs for COPD →

Sponsor

Pearl Therapeutics, Inc. — full company profile →

Who can join

Adults 40 to 80, any sex, with COPD. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Area Under the Curve for Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) From 0 to 12 Hours (AUC0-12) on Day 8 Primary · 7 days of treatment

AUC0-12 was calculated using the trapezoidal rule based on FEV1 assessments at pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours post-dosing of study drug. Primary Outcome was calculated using the trapezoidal rule and was modeled conditionally on baseline FEV1.

Group	Value	95% CI
GFF MDI (PT003) With Aerochamber	1.538	± 0.0228
GFF MDI (PT003) Without Aerochamber	1.516	± 0.0227

AUC0-12 on Day 8 Secondary · Day 8

Pharmacokinetic Parameter AUC0-12 of Glycopyrronium by Treatment on Day 8

Group	Value	95% CI
GFF MDI (PT003) With Aerochamber	128.00	± 85.63
GFF MDI (PT003) Without Aerochamber	111.39	± 63.54

AUC0-12 on Day 8 Secondary · Day 8

Pharmacokinetic Parameter AUC0-12 of Formoterol by Treatment on Day 8

Group	Value	95% CI
GFF MDI (PT003) With Aerochamber	75.46	± 43.29
GFF MDI (PT003) Without Aerochamber	78.49	± 39.17

Cmax on Day 8 Secondary · Day 8

Pharmacokinetic Parameter Cmax of Glycopyrronium by Treatment on Day 8

Group	Value	95% CI
GFF MDI (PT003) With Aerochamber	34.03	± 21.87
GFF MDI (PT003) Without Aerochamber	26.55	± 15.11

Cmax on Day 8 Secondary · Day 8

Pharmacokinetic Parameter Cmax of Formoterol by Treatment on Day 8

Group	Value	95% CI
GFF MDI (PT003) With Aerochamber	12.53	± 5.88
GFF MDI (PT003) Without Aerochamber	13.07	± 7.50

Tmax on Day 8 Secondary · Day 8

Pharmacokinetic Parameter tmax of Glycopyrronium by Treatment on Day 8

Group	Value	95% CI
GFF MDI (PT003) With Aerochamber	0.10	0.03 – 10.02
GFF MDI (PT003) Without Aerochamber	0.12	0.03 – 8

Tmax on Day 8 Secondary · Day 8

Pharmacokinetic Parameter tmax of Formoterol by Treatment on Day 8

Group	Value	95% CI
GFF MDI (PT003) With Aerochamber	0.33	0 – 10.02
GFF MDI (PT003) Without Aerochamber	0.37	0.37 – 10.17

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GFF MDI (PT003) With Aerochamber

Serious: 1/74 (1%)

Deaths: —

GFF MDI (PT003) Without Aerochamber

Serious: 2/78 (3%)

Deaths: —

Serious adverse events (3 terms)

Reaction	System	GFF MDI (PT003) With Aeroc…	GFF MDI (PT003) Without Ae…
Pancreatitis	Gastrointestinal disorders	—	—
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	—	—
Deep Vein Thrombosis	Vascular disorders	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	GFF MDI (PT003) With Aeroc…	GFF MDI (PT003) Without Ae…
Blood potassium increased	Investigations	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Vessel puncture site swelling	General disorders	—	—
Hypertension	Vascular disorders	—	—

Most-reported serious reactions: Pancreatitis, Respiratory Distress, Deep Vein Thrombosis.

Data from ClinicalTrials.gov NCT02454959 adverse events section.

Sponsor's own description

This is a Randomized, Phase III, Two-period, Open-label, Chronic-dosing (7 Days), Multi-center, Crossover Study to Assess the Efficacy of PT003 in Subjects with Moderate to Severe COPD with and without a Valved Holding Chamber.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Randomized study of the effects of Aerochamber Plus^® Flow-Vu^® on the efficacy, pharmacokinetics and safety of glycopyrronium/formoterol fumarate dihydrate metered dose inhaler in patients with chronic obstructive pulmonary disease.
   Fakih F, Spangenthal S, Sigal B, Darken P, et al · · 2018 · cited 9× · PMID 29724397 · DOI 10.1016/j.rmed.2018.03.033