Chronic Obstructive Pulmonary DiseasePhase 3NCT02343458

Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD

A Phase 3 study testing GFF MDI (PT003), FF MDI (PT005) and GP MDI (PT001) in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 166 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

A chronic dosing (24 weeks) study to assess the efficacy and safety GFF MDI; PT003), FF MDI; PT005, and GP MDI; PT001) in subjects with moderate to very severe COPD, compared with placebo. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: GFF MDI (PT003), FF MDI (PT005) and GP MDI (PT001)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,756 participants
Where: 166 sitesin 11 countries
Study dates: 30 Mar 2015to 31 Aug 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS).
Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio of <0.70.
FEV1 must be <80% predicted normal value calculated using the Third National Health and Nutrition Examination Survey (NHANES III) reference equations. (Or reference norms applicable to other regions).

Who cannot join

Significant diseases other than COPD, ie, disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
Women who are pregnant or lactating or women of childbearing potential who are not using an acceptable method of contraception.
Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. Subjects with a diagnosis of open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible.
Subjects who have a history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.

Trial locations and contacts

166 sites in 11 countries.

Country

City, postcode or hospital

166 sites in 11 countries

United States44 sites

Research Site
Abingdon, Virginia, 24210
Research Site
Anaheim, California, 92801
Research Site
Andalusia, Alabama, 36420
Research Site
Atlanta, Georgia, 30331
Research Site
Birmingham, Alabama, 35209
Research Site
Blue Ridge, Georgia, 30513
Research Site
Boulder, Colorado, 80301
Research Site
Cincinnati, Ohio, 45242
Research Site
Clearwater, Florida, 33756
Research Site
Clearwater, Florida, 33765
Research Site
Columbus, Ohio, 43215
Research Site
Columbus, Ohio, 43231
Research Site
Dayton, Ohio, 45419
Research Site
Dayton, Ohio, 45459
Research Site
Dublin, Ohio, 43016
Research Site
Easley, South Carolina, 29640
Research Site
Edina, Minnesota, 55435
Research Site
Foley, Alabama, 36535
Research Site
Fridley, Minnesota, 55432
Research Site
Gaffney, South Carolina, 29341
Research Site
Gastonia, North Carolina, 28054
Research Site
Greenville, South Carolina, 29615
Research Site
Jasper, Alabama, 35501
Research Site
Johnson City, Tennessee, 37601
Research Site
Kissimmee, Florida, 34744
Research Site
Medford, Oregon, 97504
Research Site
Miami, Florida, 33175
Research Site
Miami, Florida, 33186
Research Site
Minneapolis, Minnesota, 55407
Research Site
North Dartmouth, Massachusetts, 02747
Research Site
Oklahoma City, Oklahoma, 73103
Research Site
Panama City, Florida, 32405
Research Site
Pensacola, Florida, 32503
Research Site
Rock Hill, South Carolina, 29732
Research Site
Saint Charles, Missouri, 63301
Research Site
Seneca, South Carolina, 29678
Research Site
Spartanburg, South Carolina, 29303
Research Site
St Louis, Missouri, 63141
Research Site
Tamarac, Florida, 33321
Research Site
Tampa, Florida, 33603
Research Site
Union, South Carolina, 29379
Research Site
Winston-Salem, North Carolina, 27103
Research Site
Winter Park, Florida, 32789-4681
Research Site
Woodbury, Minnesota, 55125

Other trials in United States

Japan34 sites

Research Site
Ako-shi, 678-0239
Research Site
Asahikawa-shi, 070-8644
Research Site
Chūōku, 103-0027
Research Site
Chūōku, 103-0028
Research Site
Fukuoka, 811-1394
Research Site
Hamamatsu, 434-8511
Research Site
Himeji-shi, 671-0102
Research Site
Himeji-shi, 672-8064
Research Site
Hitachi-Naka, 312-0057
Research Site
Kakogawa-shi, 675-0023
Research Site
Kamogawa-shi, 296-0041
Research Site
Kanazawa, 920-8201
Research Site
Kishiwada-shi, 596-8501
Research Site
Kobe, 650-0047
Research Site
Koga-shi, 811-3195
Research Site
Matsumoto-shi, 390-0872
Research Site
Matsumoto-shi, 390-8621
Research Site
Mito, 310-0015
Research Site
Nagaoka-shi, 940-2085
Research Site
Nagoya, 457-0866
Research Site
Naka-gun, 319-1113
Research Site
Ohota-ku, 145-0063
Research Site
Ōita, 870-0951
Research Site
Saiki-shi, 876-0813
Research Site
Sendai, 981-8563
Research Site
Sendai, 983-0824
Research Site
Seto-shi, 489-8642
Research Site
Shimotsuga-gun, 321-0293
Research Site
tabashi City, 173-8610
Research Site
Takamatsu, 760-8538
Research Site
Toon-shi, 791-0281
Research Site
Yanagawa-shi, 832-0059
Research Site
Yokohama, 232-0066
Research Site
Yokohama, 241-0811

Other trials in Japan

China31 sites

Research Site
Beijing, 100029
Research Site
Beijing, 100050
Research Site
Beijing, 100144
Research Site
Changchun, 130021
Research Site
Changsha, 410011
Research Site
Chengdu, 610083
Research Site
Chengdu, CN-610041
Research Site
Guangzhou, 510000
Research Site
Guangzhou, 510120
Research Site
Guangzhou, 510515
Research Site
Guiyang, 510630
Research Site
Haikou, 570311
Research Site
Hefei, 230001
Research Site
Heshan, 413000
Research Site
Hohhot, 010017
Research Site
Nanchang, 330006
Research Site
Nanjing, 210009
Research Site
Nanning, 530021
Research Site
Shanghai, 200040
Research Site
Shanghai, 200120
Research Site
Shanghai, 200433
Research Site
Shengyang, 110004
Research Site
Shenyang, 110016
Research Site
Shijiazhuang, 050000
Research Site
Shijiazhuang, 050051
Research Site
Suzhou, 215006
Research Site
Taiyuan, 030001
Research Site
Tianjin, 300052
Research Site
Wuxi, 214023
Research Site
Xiamen, 361004
Research Site
Xining, 810007

Other trials in China

Poland13 sites

Research Site
Bialystok, 15-003
Research Site
Bialystok, 15-044
Research Site
Elblag, 82-300
Research Site
Inowrocław, 88-100
Research Site
Lodz, 90-153
Research Site
Lodz, 90-203
Research Site
Piekary Śląskie, 41-94O
Research Site
Rzeszów, 35-205
Research Site
Skierniewice, 96-100
Research Site
Szczecin, 70-111
Research Site
Tarnów, 33-100
Research Site
Torun, 87-100
Research Site
Warszawa Targowek, 03-291

Other trials in Poland

Germany10 sites

Research Site
Augsburg, 86150
Research Site
Berlin, 10629
Research Site
Berlin, 10787
Research Site
Berlin, 12157
Research Site
Grosshansdof, 22927
Research Site
Hamburg, 20354
Research Site
Leipzig, 04103
Research Site
Leipzig, 04357
Research Site
Lübeck, 23552
Research Site
Wiesbaden, 65187

Other trials in Germany

South Korea8 sites

Research Site
Busan, 602-715
Research Site
Daegu, 42415
Research Site
Seoul, 04551
Research Site
Seoul, 130-709
Research Site
Seoul, 130-872
Research Site
Seoul, 136-705
Research Site
Seoul, 152-703
Research Site
Wŏnju, 220-701

Other trials in South Korea

Russia7 sites

Research Site
Gatchina, 188300
Research Site
Moscow, 105229
Research Site
Moscow, 127018
Research Site
Pytigorsk, 357538
Research Site
Saint Petersburg, 195271
Research Site
Saint Petersburg, 197022
Research Site
Saint Petersburg, 198260

Other trials in Russia

Hungary6 sites

Research Site
Budapest, 1135
Research Site
Gödöllő, 2100
Research Site
Nyíregyháza, 4400
Research Site
Pécs, 7635
Research Site
Siófok, 8600
Research Site
Szeged, H-6722

Other trials in Hungary

United Kingdom5 sites

Research Site
Dundee, DD1 9SY
Research Site
London, EC1M 6BQ
Research Site
London, W1G 8HU
Research Site
Northwood, HA6 2RN
Research Site
Sidcup, DA14 6LT

Other trials in United Kingdom

Czechia4 sites

Research Site
Jindřichův Hradec, 37701
Research Site
Ostrava-Hrabuvka, 700 30
Research Site
Prague, 15000
Research Site
Teplice, 415 01

Other trials in Czechia

Taiwan4 sites

Research Site
Kaohsiung City, 83301
Research Site
Taichung, 40447
Research Site
Taichung, 40705
Research Site
Taipei, 10002

Other trials in Taiwan

About this study

Official title: A Randomized, Double-Blind, Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo

A chronic dosing (24 weeks) study to assess the efficacy and safety GFF MDI; PT003), FF MDI; PT005, and GP MDI; PT001) in subjects with moderate to very severe COPD, compared with placebo.

Read the detailed description

A randomized, double-blind, chronic dosing (24 weeks), placebo-controlled, parallel group, multi-center study to assess the efficacy and safety of glycopyrronium and formoterol fumarate inhalation aerosol (GFF; PT003), formoterol fumarate inhalation aerosol (FF; PT005), and glycopyrronium inhalation aerosol (GP; PT001) in subjects with moderate to very severe COPD, compared with placebo.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: GFF MDI (PT003), FF MDI (PT005), GP MDI (PT001), Placebo MDI
Keywords: COPD
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GFF MDI (PT003)Drug
Also called Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol
Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
FF MDI (PT005)Drug
Also called Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol
Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
GP MDI (PT001)Drug
Also called Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol
Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
Placebo MDIDrug
Also called Placebo (matching) for GFF MDI, FF MDI, and GP MDI
Placebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID)

Study groups in NCT02343458
Study group	Role	What they receive
GFF MDI (PT003)	Experimental	Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID) Receives: Drug: GFF MDI (PT003)
FF MDI (PT005)	Experimental	Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID) Receives: Drug: FF MDI (PT005)
GP MDI (PT001)	Experimental	Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID) Receives: Drug: GP MDI (PT001)
Placebo MDI	Placebo comparator	Placebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID) Receives: Drug: Placebo MDI

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 of Treatment (US/China Approach)
For the US/China approach, the primary endpoint was the change from baseline in morning pre-dose trough FEV1 at Week 24 of treatment
Measured: at week 24
Change From Baseline in Morning Pre-dose Trough FEV1 Over Weeks 12-24, Japan Approach
Change from baseline in morning pre-dose trough FEV1 over weeks 12-24, Japan approach
Measured: over weeks 12-24
Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks. Primary Endpoint, EU/SK/TW Approach, Secondary Endpoint US/China Approach.
Change from baseline in morning pre-dose trough FEV1 over 24 weeks. Primary endpoint, EU/SK/TW approach, Secondary endpoint US/China approach.
Measured: over 24 weeks

Secondary outcomes (14)

TDI Focal Score Over 24 Weeks, US/China and EU/SK/TW Approach
TDI focal score over 24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9
Measured: over 24 Weeks
TDI Focal Score Over Weeks 12-24 Japan Approach
TDI focal score over 12-24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9
Measured: over Weeks 12-24
TDI Focal Score Over 24 Weeks - US/China and EU/SK/TW Approaches -Symptomatic Population
TDI focal score over 24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9
Measured: over 24 Weeks
TDI Focal Score Over Weeks 12-24 - Japan Approach - Symptomatic Population
TDI focal score over 12-24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9
Measured: over weeks 12-24
Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing at Week 24 US/China Approach
Peak change from baseline in FEV1 within 2 hours post-dosing at Week 24 US/China approach
Measured: at week 24
Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over Weeks 12-24 Japan Approach
Peak change from baseline in FEV1 within 2 hours post-dosing over weeks 12-24 Japan approach
Measured: over weeks 12-24
Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over 24 Weeks EU/SK/TW Approach
Peak change from baseline in FEV1 within 2 hours post-dosing over 24 weeks EU/SK/TW approach
Measured: over 24 weeks
Change From Baseline in SGRQ Total Score at Week 24, US/China Approach
Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life
Measured: at week 24
Change From Baseline in SGRQ Total Score Over Weeks 12-24 , Japan & EU/SK/TW Approach
Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life
Measured: over weeks 12-24
Change From Baseline in SGRQ Total Score at Week 24 in Symptomatic Population, US/China Approach
Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life
Measured: at week 24
Change From Baseline in SGRQ Total Score Over Weeks 12-24, in Symptomatic Population, Japan & EU/SK/TW Approach
Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life
Measured: over weeks 12-24
Change From Baseline in Average Daily Rescue Ventolin Use Over 24 Weeks in RVU Population, All Approaches
Change from baseline in average daily rescue Ventolin use over 24 weeks in RVU population, all approaches
Measured: over 24 weeks
FEV1 Measured at 5 Minutes Post-dose on Day 1
Onset of Action as Assessed by FEV1 Day 1 at 5 Minutes Post-Dose. Reported is the FEV1 measured at 5 minutes post-dose on Day 1 as the first time point when the difference from Placebo was statistically significant
Measured: Assessed at 5-minutes post dose on Day 1
FEV1 Measured at 15 Minutes Post-dose on Day 1
Onset of Action as Assessed by FEV1 Day 1 at 15 Minutes Post-Dose. Reported is the FEV1 measured at 15 minutes post-dose on Day 1 as the first time point when the difference from Placebo was statistically significant
Measured: Assessed at 15-minute post dose on Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Mar 201531 Aug 2017

First posted22 Jan 2015 (estimated)
Study start30 Mar 2015
Primary completion31 Aug 2017
Study completion31 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,756 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02343458
Sponsor's protocol ID: PT003014
Status last verified: Jan 2019
First submitted: 6 Jan 2015
Last updated: 20 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: AstraZeneca's policy is to share data with researchers if the request is in scope of our policy. The policy and additional information can be found on astrazenecaclinicaltrials.com.

Publications

Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314.
PubMed 35815359
Martinez FJ, Lipworth BJ, Rabe KF, Collier DJ, Ferguson GT, Sethi S, Feldman GJ, O'Brien G, Jenkins M, Reisner C. Benefits of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) in improving lung function and reducing exacerbations in patients with moderate-to-very severe COPD: a pooled analysis of the PINNACLE studies. Respir Res. 2020 May 25;21(1):128. doi: 10.1186/s12931-020-01388-y.
PubMed 32450869
Martinez FJ, Rabe KF, Lipworth BJ, Arora S, Jenkins M, Martin UJ, Reisner C. Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Improves Lung Function versus Monotherapies in GOLD Category A Patients with COPD: Pooled Data from the Phase III PINNACLE Studies. Int J Chron Obstruct Pulmon Dis. 2020 Jan 9;15:99-106. doi: 10.2147/COPD.S229794. eCollection 2020.
PubMed 32021148
Chen R, Zhong N, Wang HY, Zhao L, Mei X, Qin Z, Huang J, Assam PN, Maes A, Siddiqui S, Martin UJ, Reisner C. Efficacy And Safety Of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (GFF MDI) Formulated Using Co-Suspension Delivery Technology In Chinese Patients With COPD. Int J Chron Obstruct Pulmon Dis. 2020 Jan 8;15:43-56. doi: 10.2147/COPD.S223638. eCollection 2020.
PubMed 32021143

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo
ClinicalTrials.gov ID: NCT02343458
Acronym / sponsor ID: PT003014
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,756 participants (actual)
Lead sponsor: Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 30 Mar 2015 (actual)
Primary completion: 31 Aug 2017 (actual)
Study completion: 31 Aug 2017 (actual)
First posted: 22 Jan 2015 (estimated)
Results: Posted 20 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A chronic dosing (24 weeks) study to assess the efficacy and safety GFF MDI; PT003), FF MDI; PT005, and GP MDI; PT001) in subjects with moderate to very severe COPD, compared with placebo.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
GFF MDI (PT003)	Experimental	Drug: GFF MDI (PT003)Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
FF MDI (PT005)	Experimental	Drug: FF MDI (PT005)Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
GP MDI (PT001)	Experimental	Drug: GP MDI (PT001)Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
Placebo MDI	Placebo comparator	Drug: Placebo MDIPlacebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID)

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS).
Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio of <0.70.
FEV1 must be <80% predicted normal value calculated using the Third National Health and Nutrition Examination Survey (NHANES III) reference equations. (Or reference norms applicable to other regions).

Key exclusion criteria (7 listed)

Significant diseases other than COPD, ie, disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
Women who are pregnant or lactating or women of childbearing potential who are not using an acceptable method of contraception.
Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GFF MDI (PT003)Also: Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation AerosolGlycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)	Drug	GFF MDI (PT003)
FF MDI (PT005)Also: Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation AerosolFormoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)	Drug	FF MDI (PT005)
GP MDI (PT001)Also: Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation AerosolGlycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID)	Drug	GP MDI (PT001)
Placebo MDIAlso: Placebo (matching) for GFF MDI, FF MDI, and GP MDIPlacebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID)	Drug	Placebo MDI

Primary outcome

Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 of Treatment (US/China Approach)
Time frame: at week 24
For the US/China approach, the primary endpoint was the change from baseline in morning pre-dose trough FEV1 at Week 24 of treatment
Change From Baseline in Morning Pre-dose Trough FEV1 Over Weeks 12-24, Japan Approach
Time frame: over weeks 12-24
Change from baseline in morning pre-dose trough FEV1 over weeks 12-24, Japan approach
Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks. Primary Endpoint, EU/SK/TW Approach, Secondary Endpoint US/China Approach.
Time frame: over 24 weeks
Change from baseline in morning pre-dose trough FEV1 over 24 weeks. Primary endpoint, EU/SK/TW approach, Secondary endpoint US/China approach.

14 secondary outcomes

TDI Focal Score Over 24 Weeks, US/China and EU/SK/TW Approach
Time frame: over 24 Weeks
TDI Focal Score Over Weeks 12-24 Japan Approach
Time frame: over Weeks 12-24
TDI Focal Score Over 24 Weeks - US/China and EU/SK/TW Approaches -Symptomatic Population
Time frame: over 24 Weeks
TDI Focal Score Over Weeks 12-24 - Japan Approach - Symptomatic Population
Time frame: over weeks 12-24
Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing at Week 24 US/China Approach
Time frame: at week 24
Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over Weeks 12-24 Japan Approach
Time frame: over weeks 12-24
Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over 24 Weeks EU/SK/TW Approach
Time frame: over 24 weeks
Change From Baseline in SGRQ Total Score at Week 24, US/China Approach
Time frame: at week 24
Change From Baseline in SGRQ Total Score Over Weeks 12-24 , Japan & EU/SK/TW Approach
Time frame: over weeks 12-24
Change From Baseline in SGRQ Total Score at Week 24 in Symptomatic Population, US/China Approach
Time frame: at week 24
Change From Baseline in SGRQ Total Score Over Weeks 12-24, in Symptomatic Population, Japan & EU/SK/TW Approach
Time frame: over weeks 12-24
Change From Baseline in Average Daily Rescue Ventolin Use Over 24 Weeks in RVU Population, All Approaches
Time frame: over 24 weeks
FEV1 Measured at 5 Minutes Post-dose on Day 1
Time frame: Assessed at 5-minutes post dose on Day 1
FEV1 Measured at 15 Minutes Post-dose on Day 1
Time frame: Assessed at 15-minute post dose on Day 1

Results and safety

Results posted to the registry on 20 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GFF MDI 14.4/9.6 ug	555	494
FF MDI 9.6 ug	483	417
GP MDI 14.4 ug	480	417
Placebo MDI	238	200

Primary outcome: Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 of Treatment (US/China Approach)

Time frame: at week 24. Least squares mean (95% Confidence Interval). Unit: mL

Measure	GFF MDI 14.4/9.6 ug n = 488	FF MDI 9.6 ug n = 413	GP MDI 14.4 ug n = 412	Placebo MDI n = 196
Value	120 (102 to 138)	47 (28 to 67)	60 (41 to 80)	-45 (-73 to -17)

Population analysed: ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data

Primary outcome: Change From Baseline in Morning Pre-dose Trough FEV1 Over Weeks 12-24, Japan Approach

Time frame: over weeks 12-24. Least squares mean (95% Confidence Interval). Unit: mL

Measure	GFF MDI 14.4/9.6 ug n = 517	FF MDI 9.6 ug n = 436	GP MDI 14.4 ug n = 437	Placebo MDI n = 205
Value	128 (113 to 143)	54 (38 to 71)	74 (58 to 91)	-25 (-49 to -1)

Primary outcome: Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks. Primary Endpoint, EU/SK/TW Approach, Secondary Endpoint US/China Approach.

Time frame: over 24 weeks. Least squares mean (95% Confidence Interval). Unit: mL

Measure	GFF MDI 14.4/9.6 ug n = 541	FF MDI 9.6 ug n = 467	GP MDI 14.4 ug n = 465	Placebo MDI n = 225
Value	135 (121 to 149)	63 (48 to 78)	80 (65 to 94)	-20 (-41 to 2)

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time the subject signed consent throughout the four treatment periods of 24 weeks and up to 10 days following the last dose of study drug.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GFF MDI 14.4/9.6 ug	53 of 551 (9.6%)	166 of 551 (30.1%)	1 of 551
FF MDI 9.6 ug	40 of 480 (8.3%)	123 of 480 (25.6%)	1 of 480
GP MDI 14.4 ug	34 of 474 (7.2%)	128 of 474 (27%)	1 of 474
Placebo MDI	19 of 235 (8.1%)	61 of 235 (26%)	1 of 235

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35815359Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314.
Derived from this study: PubMed 32450869Martinez FJ, Lipworth BJ, Rabe KF, Collier DJ, Ferguson GT, Sethi S, Feldman GJ, O'Brien G, Jenkins M, Reisner C. Benefits of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) in improving lung function and reducing exacerbations in patients with moderate-to-very severe COPD: a pooled analysis of the PINNACLE studies. Respir Res. 2020 May 25;21(1):128. doi: 10.1186/s12931-020-01388-y.
Derived from this study: PubMed 32021148Martinez FJ, Rabe KF, Lipworth BJ, Arora S, Jenkins M, Martin UJ, Reisner C. Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Improves Lung Function versus Monotherapies in GOLD Category A Patients with COPD: Pooled Data from the Phase III PINNACLE Studies. Int J Chron Obstruct Pulmon Dis. 2020 Jan 9;15:99-106. doi: 10.2147/COPD.S229794. eCollection 2020.
Derived from this study: PubMed 32021143Chen R, Zhong N, Wang HY, Zhao L, Mei X, Qin Z, Huang J, Assam PN, Maes A, Siddiqui S, Martin UJ, Reisner C. Efficacy And Safety Of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (GFF MDI) Formulated Using Co-Suspension Delivery Technology In Chinese Patients With COPD. Int J Chron Obstruct Pulmon Dis. 2020 Jan 8;15:43-56. doi: 10.2147/COPD.S223638. eCollection 2020.
Updated cover pageLink provided by the sponsor.
Updated Cover pageLink provided by the sponsor.
Updated Cover pageLink provided by the sponsor.
Updated cover pageLink provided by the sponsor.
Individual participant dataSharing planned: Yes. AstraZeneca's policy is to share data with researchers if the request is in scope of our policy. The policy and additional information can be found on astrazenecaclinicaltrials.com.

Related trials for Chronic Obstructive Pulmonary Disease

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Colin Reisner, MD study chair

Pearl Therapeutics, Inc.

166 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GFF MDI (PT003), FF MDI (PT005) and GP MDI (PT001) in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 166 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 166 sites in United States, Japan, China, Poland, Germany and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 of Treatment (US/China Approach) (time frame: at week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02343458, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.