NCT02347072 is a Phase 3 clinical trial of GFF MDI (PT003) in COPD, sponsored by Pearl Therapeutics, Inc..

Who is sponsoring NCT02347072?

NCT02347072 is sponsored by Pearl Therapeutics, Inc..

What drugs are being tested in NCT02347072?

Interventions in NCT02347072: GFF MDI (PT003), Placebo MDI, Spiriva® Respimat® (Tiotropium Bromide).

Is NCT02347072 still recruiting?

NCT02347072 is currently completed. Last updated 19 April 2017.

Are results published for NCT02347072?

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

Last reviewed 2017-04-19 · How we verify

NCT02347072

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, Open-Label Spiriva® Respimat® as an Active Control, and Placebo

Completed Phase 3 Results posted Last updated 19 April 2017

What this trial tests

Phase 3 trial testing GFF MDI (PT003) in COPD in 80 participants. Completed in 1 March 2016.

Timeline

1 February 2015

Primary endpoint
1 August 2015

1 March 2016

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	80
Start date	1 February 2015
Primary completion	1 August 2015
Estimated completion	1 March 2016

Drugs / interventions tested

GFF MDI (PT003) — full drug profile →
Placebo MDI — full drug profile →
Spiriva® Respimat® (Tiotropium Bromide) — 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.

Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-24 Primary · Pre dose, 15 and 30 minutes, 1, 2, 4, 8, 12, 12.25, 12.5, 13, 14, 16, 22, and 24 hours post the morning dose on Day 29

Normalized Forced Expiratory Volume in 1 second (FEV1) Area Under the Curve (AUC) 0-24

Group	Value	95% CI
GFF MDI	0.192	0.141 – 0.243
Spiriva Respimat	0.112	0.061 – 0.162
Placebo	-0.072	-0.123 – -0.022

FEV1 AUC12-24 Secondary · Pre dose, 15 and 30 minutes, 1, 2, 4, 8, and 12 hours post the evening dose on Day 29

Normalized FEV1 AUC12-24

Group	Value	95% CI
GFF MDI	0.159	0.104 – 0.214
Spiriva Respimat	0.039	-0.015 – 0.094
Placebo	-0.118	-0.173 – -0.063

FEV1 AUC0-12 Secondary · Pre dose, 15 and 30 minutes, 1, 2, 4, 8, and 12 hours post the morning dose on Day 29

Normalized FEV1 AUC0-12

Group	Value	95% CI
GFF MDI	0.226	0.175 – 0.276
Spiriva Respimat	0.178	0.127 – 0.228
Placebo	-0.026	-0.077 – 0.025

Peak Change From Baseline in FEV1 Evening Secondary · Baseline and Day 29

Peak Change From Baseline in FEV1 Evening

Group	Value	95% CI
GFF MDI	0.395	0.334 – 0.456
Spiriva Respimat	0.230	0.170 – 0.291
Placebo	0.058	-0.003 – 0.119

Peak Change From Baseline in FEV1 Morning Secondary · Baseline and Day 29

Peak Change From Baseline in FEV1 Morning

Group	Value	95% CI
GFF MDI	0.406	0.351 – 0.462
Spiriva Respimat	0.325	0.270 – 0.381
Placebo	0.129	0.073 – 0.185

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

Morning Pre-Dose Trough FEV1 on Day 29

Group	Value	95% CI
GFF MDI	0.140	0.095 – 0.185
Spiriva Respimat	0.097	0.053 – 0.142
Placebo	-0.020	-0.066 – 0.025

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

Morning Pre-Dose Trough FEV1 on Day 30

Group	Value	95% CI
GFF MDI	0.129	0.073 – 0.185
Spiriva Respimat	0.072	0.015 – 0.128
Placebo	-0.073	-0.130 – -0.017

Peak Change From Baseline in IC (Inspiratory Capacity) Evening Secondary · Baseline and Day 29

Peak Change From Baseline in IC Evening

Group	Value	95% CI
GFF MDI	0.421	0.343 – 0.498
Spiriva Respimat	0.297	0.221 – 0.372
Placebo	0.109	0.032 – 0.186

Peak Change From Baseline in IC Morning Secondary · Baseline and Day 29

Peak Change From Baseline in IC Morning

Group	Value	95% CI
GFF MDI	0.454	0.388 – 0.520
Spiriva Respimat	0.374	0.307 – 0.440
Placebo	0.206	0.139 – 0.273

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: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GFF MDI

Serious: 2/75 (3%)

Deaths: —

Spiriva Respimat

Serious: 2/73 (3%)

Deaths: —

Placebo

Serious: 2/72 (3%)

Deaths: —

Serious adverse events (8 terms)

Reaction	System	GFF MDI	Spiriva Respimat	Placebo
Acute Myocardial Infarction	Cardiac disorders	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—	—	—
Influenza	Infections and infestations	—	—	—
Pneumonia	Infections and infestations	—	—	—
Sepsis	Infections and infestations	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—
Chest pain	General disorders	—	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	GFF MDI	Spiriva Respimat	Placebo
Vomiting	Gastrointestinal disorders	—	—	—
Tremor	Nervous system disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Furuncle	Infections and infestations	—	—	—
Headache	Nervous system disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—

Most-reported serious reactions: Acute Myocardial Infarction, Atrial fibrillation, Chronic obstructive pulmonary disease, Influenza, Pneumonia, Sepsis, Small intestinal obstruction, Chest pain.

Data from ClinicalTrials.gov NCT02347072 adverse events section.

Sponsor's own description

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.

Publications & conference data

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

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
COPD10: Birmingham,United Kingdom, July 2016.
Stockley RA. · · 2017 · cited 1× · PMID 28848934 · DOI 10.15326/jcopdf.4.3.2017.0137

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
NCT02347085 — 24-hour Lung Function in Subjects With Moderate to Very Severe COPD After Treatment With PT003 and Placebo MDI · 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 NCT02347072 (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 April 2017

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/NCT02347072.

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

NCT02347072

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (8 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of GFF MDI (PT003)

Other recruiting trials for COPD

Other Pearl Therapeutics, Inc. trials

Verify against primary sources