NCT02347085 is a Phase 3 clinical trial of GFF MDI (PT003) in COPD, sponsored by Pearl Therapeutics, Inc..

Who is sponsoring NCT02347085?

NCT02347085 is sponsored by Pearl Therapeutics, Inc..

What drugs are being tested in NCT02347085?

Interventions in NCT02347085: GFF MDI (PT003), Placebo MDI.

Is NCT02347085 still recruiting?

NCT02347085 is currently completed. Last updated 19 July 2018.

Are results published for NCT02347085?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-07-19 · How we verify

NCT02347085

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

24-hour Lung Function in Subjects With Moderate to Very Severe COPD After Treatment With PT003 and Placebo MDI

Completed Phase 3 Results posted Last updated 19 July 2018

What this trial tests

Phase 3 trial testing GFF MDI (PT003) in COPD in 43 participants. Completed in 1 June 2015.

Timeline

1 February 2015

Primary endpoint
1 June 2015

1 June 2015

Quick facts

Lead sponsor	Pearl Therapeutics, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	43
Start date	1 February 2015
Primary completion	1 June 2015
Estimated completion	1 June 2015

Drugs / interventions tested

GFF MDI (PT003) — full drug profile →
Placebo MDI — full drug profile →

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.

FEV1 AUC0-24 on Day 29 Primary · Day 29

Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC)0-24 on Day 29

Group	Value	95% CI
GFF MD (PT003)	0.166	0.110 – 0.222
Placebo	-0.083	-0.143 – -0.024

FEV1 AUC12-24 on Day 29 Secondary · Day 29

FEV1 AUC12-24 on Day 29

Group	Value	95% CI
GFF MD (PT003)	0.115	0.055 – 0.175
Placebo	-0.127	-0.191 – -0.063

FEV1 AUC0-12 on Day 29 Secondary · Day 29

FEV1 AUC0-12 on Day 29

Group	Value	95% CI
GFF MD (PT003)	0.216	0.157 – 0.276
Placebo	-0.039	-0.103 – 0.025

Peak Change From Baseline in FEV1 on Day 29 Secondary · Day 29

Peak Change From Baseline in FEV1 following evening Dose on Day 29

Group	Value	95% CI
GFF MD (PT003)	0.344	0.275 – 0.412
Placebo	0.050	-0.023 – 0.124

Peak Change From Baseline in FEV1 on Day 29 Secondary · Day 29

Peak Change From Baseline in FEV1 following the morning dose on Day 29

Group	Value	95% CI
GFF MD (PT003)	0.410	0.338 – 0.482
Placebo	0.134	0.058 – 0.209

Morning Pre-Dose Trough FEV1 on Day 29 Secondary · Day 29

Morning Pre-Dose Trough FEV on Day 29

Group	Value	95% CI
GFF MD (PT003)	0.130	0.086 – 0.173
Placebo	-0.012	-0.058 – 0.033

Morning Pre-Dose Trough FEV1 on Day 30 Secondary · Day 30

Morning Pre-Dose Trough FEV1 on Day 30

Group	Value	95% CI
GFF MD (PT003)	0.090	0.032 – 0.148
Placebo	-0.064	-0.124 – -0.003

Peak Change From Baseline in Inspiratory Capacity (IC) Following the Evening Dose on Day 29 Secondary · Day 29

Peak Change from Baseline in Inspiratory Capacity (IC) following the evening dose on Day 29

Group	Value	95% CI
GFF MD (PT003)	0.486	0.369 – 0.603
Placebo	0.105	-0.019 – 0.229

Peak Change From Baseline in IC Following the Morning Dose on Day 29 Secondary · Day 29

Peak Change from Baseline in IC following the morning dose on Day 29

Group	Value	95% CI
GFF MD (PT003)	0.543	0.448 – 0.639
Placebo	0.208	0.106 – 0.310

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were 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: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GFF MDI PT003

Serious: 1/40 (3%)

Deaths: —

Placebo

Serious: 1/40 (3%)

Deaths: —

Serious adverse events (2 terms)

Reaction	System	GFF MDI PT003	Placebo
Abscess limb	Infections and infestations	—	—
Gastroenteritis	Infections and infestations	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	GFF MDI PT003	Placebo
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Sinus Congestion	Respiratory, thoracic and mediastinal disorders	—	—
Hypertenstion	Vascular disorders	—	—

Most-reported serious reactions: Abscess limb, Gastroenteritis.

Data from ClinicalTrials.gov NCT02347085 adverse events section.

Sponsor's own description

Randomized, Phase IIIb, Two-period, Two-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 and Placebo MDI

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Mechanisms, Pathophysiology and Currently Proposed Treatments of Chronic Obstructive Pulmonary Disease.
Rodrigues SO, Cunha CMCD, Soares GMV, Silva PL, et al · · 2021 · cited 61× · PMID 34681202 · DOI 10.3390/ph14100979
24-h bronchodilation and inspiratory capacity improvements with glycopyrrolate/formoterol fumarate via co-suspension delivery technology in COPD.
Reisner C, Gottschlich G, Fakih F, Koser A, et al · · 2017 · cited 15× · PMID 28821260 · DOI 10.1186/s12931-017-0636-4
Network meta-analysis of the efficacy and safety of monoclonal antibodies and traditional conventional dichotomous agents for chronic obstructive pulmonary disease.
Xiong Y, Hu JQ, Tang HL, Zhao ZX, et al · · 2024 · cited 2× · PMID 38414617 · DOI 10.3389/fmed.2024.1334442

Verify or expand the search:

Other trials of GFF MDI (PT003)

Trials testing the same drug.

NCT02685293 — Study to Evaluate the Treatment Effect of PT003 on Cardiovascular Hemodynamics in Subjects With Moderate to Severe COPD · Phase 3 · terminated
NCT03262012 — Study to Assess the Safety and Efficacy of PT010, PT003, and PT009 in Japanese Subjects With COPD Compared With Symbicor · Phase 3 · completed
NCT02343458 — Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD · Phase 3 · completed
NCT02347072 — 24-hour Lung Function in Subjects With Moderate to Very Severe COPD After Treatment With PT003, Open-Label Spiriva® Resp · Phase 3 · completed

Other recruiting trials for COPD

Currently open trials in the same condition.

NCT07344649 — Turkish Validation of the Nijmegen Questionnaire in COPD · recruiting
NCT07524023 — Emotional-distress-based Integrated Care Programme in Patients With Stable COPD · NA · recruiting
NCT07460154 — Structured Review: To Optimise Management and Prevent Harm in COPD · NA · recruiting
NCT07462221 — Effect of Telenursing on Oral Health · NA · recruiting
NCT07051707 — Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD · NA · recruiting

Other Pearl Therapeutics, Inc. trials

Trials by the same sponsor.

NCT03081247 — To Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructiv · Phase 3 · withdrawn
NCT03358147 — Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistant Asthma · Phase 2, PHASE3 · completed
NCT03311373 — A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavai · Phase 1 · completed
NCT03250182 — A Study to Assess the PK and Safety of PT010 in Subjects With COPD Following Single and Repeat Dose · Phase 1 · completed
NCT03075267 — Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02347085 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pearl Therapeutics, Inc.
Last refreshed: 19 July 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02347085.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing