Chronic Obstructive Pulmonary DiseasePhase 3NCT01854645
Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)
A Phase 3 study testing GFF MDI, GP MDI and FF MDI in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 139 sites in 3 countries.
Trial summary
The overall objective of this study is to assess the efficacy and safety of treatment with PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to very severe COPD. 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, GP MDI and FF MDI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,103 participants
- Where
- 139 sitesin 3 countries
- Study dates
- May 2013to Feb 2015
- 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
- Male or female subjects at least 40 years of age and no older than 80 at Visit 1.
- 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.
- Average f the -60 and the -30 min pre-dose FEV1 assessments must be < 80% predicted normal value calculated using National Health and Nutrition Examination Survey (NHANES) III reference equations.
- Subjects willing and, in the opinion of the investigator, able to adjust current COPD therapy as required by the protocol
Who cannot join
- Significant diseases other than COPD, i.e. disease or condition which, in the opinion of the investigator, may put the patient 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
- Current diagnosis of asthma or alpha-1 antitrypsin deficiency
- Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea
- Hospitalized due to poorly controlled COPD within 3 months prior to screening or during the Screening Period
- Poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to screening or during the Screening Period
- Lower respiratory tract infections that required antibiotics within 6 weeks prior to screening or during the Screening Period
Show all 14Show fewer
- Unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of enrollment.
- Recent history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft within the past three months
- Congestive heart failure (CHF) New York Heart Association (NYHA) Class III/IV)
- Clinically significant abnormal 12-lead ECG
- Abnormal liver function tests defined as aspartate transaminase (AST), alanine transaminase (ALT), or total bilirubin ≥ 1.5 times upper limit of normal at Visit 1 and on repeat testing
- Cancer not in complete remission for at least five years
- History of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, lactose/milk protein or any component of the MDI
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
139 sites in 3 countries.
139 sites in 3 countries
United States121 sites
Pearl Investigative Site
Abingdon, Virginia
Pearl Investigative Site
Albuquerque, New Mexico
Pearl Investigative Site
Anaheim, California
Pearl Investigative Site
Andalusia, Alabama
Pearl Investigative Site
Anderson, Indiana
Pearl Investigative Site
Anniston, Alabama
Pearl Investigative Site
Athens, Alabama
Pearl Investigative Site
Atlanta, Georgia
Pearl Investigative Site
Austell, Georgia
Pearl Investigative Site
Austin, Texas
Pearl Investigative Site
Avon, Indiana
Pearl Investigative Site
Baltimore, Maryland
Pearl Investigative Site
Bellevue, Nebraska
Pearl Investigative Site
Bend, Oregon
Pearl Investigative Site
Birmingham, Alabama
Pearl Investigative Site
Brandon, Florida
Pearl Investigative Site
Bristol, Tennessee
Pearl Investigative Site
Burlington, North Carolina
Pearl Investigative Site
Carlsbad, California
Pearl Investigative Site
Champaign, Illinois
Pearl Investigative Site
Charleston, South Carolina
Pearl Investigative Site
Charlotte, North Carolina
Pearl Investigative Site
Cincinnati, Ohio
Pearl Investigative Site
Clearwater, Florida
Pearl Investigative Site
Coeur d'Alene, Idaho
Pearl Investigative Site
Colorado Springs, Colorado
Pearl Investigative Site
Columbus, Georgia
Pearl Investigative Site
Columbus, Ohio
Pearl Investigative Site
Corning, New York
Pearl Investigative Site
Danbury, Connecticut
Pearl Investigative Site
Dayton, Ohio
Pearl Investigative Site
Denver, Colorado
Pearl Investigative Site
Dublin, Ohio
Pearl Investigative Site
Duluth, Georgia
Pearl Investigative Site
Easley, South Carolina
Pearl Investigative Site
Edina, Minnesota
Pearl Investigative Site
El Paso, Texas
Pearl Investigative Site
Elwood, Indiana
Pearl Investigative Site
Evanston, Illinois
Pearl Investigative Site
Evansville, Indiana
Pearl Investigative Site
Fort Collins, Colorado
Pearl Investigative Site
Fort Worth, Texas
Pearl Investigative Site
Fridley, Minnesota
Pearl Investigative Site
Gaffney, South Carolina
Pearl Investigative Site
Gainesville, Georgia
Pearl Investigative Site
Greensboro, North Carolina
Pearl Investigative Site
Greenville, South Carolina
Pearl Investigative Site
Hollywood, Maryland
Pearl Investigative Site
Houston, Texas
Pearl Investigative Site
Huntersville, North Carolina
Pearl Investigative Site
Huntsville, Texas
Pearl Investigative Site
Iowa City, Iowa
Pearl Investigative Site
Johnson City, Tennessee
Pearl Investigative Site
Kingsport, Tennessee
Pearl Investigative Site
Lafayette, Louisiana
Pearl Investigative Site
Lakewood, California
Pearl Investigative Site
Las Vegas, Nevada
Pearl Investigative Site
Lehigh Acres, Florida
Pearl Investigative Site
Livonia, Michigan
Pearl Investigative Site
Longview, Texas
Pearl Investigative Site
Los Angeles, California
Pearl Investigative Site
Louisville, Kentucky
Pearl Investigative Site
Lufkin, Texas
Pearl Investigative Site
Medford, Oregon
Pearl Investigative Site
Mesa, Arizona
Pearl Investigative Site
Miami, Florida
Pearl Investigative Site
Midvale, Utah
Pearl Investigative Site
Minneapolis, Minnesota
Pearl Investigative Site
Missoula, Montana
Pearl Investigative Site
Monroeville, Pennsylvania
Pearl Investigative Site
Morgantown, West Virginia
Pearl Investigative Site
Mt. Pleasant, South Carolina
Pearl Investigative Site
Murrells Inlet, South Carolina
Pearl Investigative Site
Myrtle Beach, South Carolina
Pearl Investigative Site
New Braunfels, Texas
Pearl Investigative Site
Ocean City, New Jersey
Pearl Investigative Site
Omaha, Nebraska
Pearl Investigative Site
Oregon, Ohio
Pearl Investigative Site
Ormond Beach, Florida
Pearl Investigative Site
Panama City, Florida
Pearl Investigative Site
Pasadena, California
Pearl Investigative Site
Pensacola, Florida
Pearl Investigative Site
Peoria, Illinois
Pearl Investigative Site
Philadelphia, Pennsylvania
Pearl Investigative Site
Phoenix, Arizona
Pearl Investigative Site
Portland, Oregon
Pearl Investigative Site
Poway, California
Pearl Investigative Site
Raleigh, North Carolina
Pearl Investigative Site
Rapid City, South Dakota
Pearl Investigative Site
Richmond, Virginia
Pearl Investigative Site
River Forest, Illinois
Pearl Investigative Site
Rock Hill, South Carolina
Pearl Investigative Site
Sacramento, California
Pearl Investigative Site
Saint Charles, Missouri
Pearl Investigative Site
Salt Lake City, Utah
Pearl Investigative Site
San Antonio, Texas
Pearl Investigative Site
San Diego, California
Pearl Investigative Site
Scottsdale, Arizona
Pearl Investigative Site
South Burlington, Vermont
Pearl Investigative Site
Southfield, Michigan
Pearl Investigative Site
Spartanburg, South Carolina
Pearl Investigative Site
Spokane, Washington
Pearl Investigative Site
Springfield, Missouri
Pearl Investigative Site
St Louis, Missouri
Pearl Investigative Site
St. Petersburg, Florida
Pearl Investigative Site
Sunset, Louisiana
Pearl Investigative Site
Tacoma, Washington
Pearl Investigative Site
Tampa, Florida
Pearl Investigative Site
Topeka, Kansas
Pearl Investigative Site
Tucson, Arizona
Pearl Investigative Site
Tullahoma, Tennessee
Pearl Investigative Site
Tustin, California
Pearl Investigative Site
Union, South Carolina
Pearl Investigative Site
Vista, California
Pearl Investigative Site
Waterbury, Connecticut
Pearl Investigative Site
West Allis, Wisconsin
Pearl Investigative Site
Wheat Ridge, Colorado
Pearl Investigative Site
Wilmington, North Carolina
Pearl Investigative Site
Winston-Salem, North Carolina
Pearl Investigative Site
Winter Park, Florida
Pearl Investigative Site
Woodbury, Minnesota
Australia12 sites
Pearl Investigative Site
Adelaide, South Australia
Pearl Investigative Site
Box Hill, Victoria
Pearl Investigative Site
Brisbane, Queensland
Pearl Investigative Site
Cairns, Queensland
Pearl Investigative Site
Daw Park, South Australia
Pearl Investigative Site
Heidelberg, Victoria
Pearl Investigative Site
Nedlands, Western Australia
Pearl Investigative Site
New Lambton, New South Wales
Pearl Investigative Site
Perth, Western Australia
Pearl Investigative Site
Toorak Gardens, South Australia
Pearl Investigative Site
Westmead, New South Wales
Pearl Investigative Site
Wooloongabba, Queensland
New Zealand6 sites
Pearl Investigative Site
Caversham, Dunedin
Pearl Investigative Site
Greenlane, East Aukland
Pearl Investigative Site
Hamilton, Waikato Region
Pearl Investigative Site
Newtown, Wellington Region
Pearl Investigative Site
Otahuhu, Aukland
Pearl Investigative Site
Tauranga
About this study
Official title: A Randomized, Double Blind, Chronic Dosing, 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 and Spiriva® Handihaler® (Tiotropium Bromide 18 µg Open-Label) as an Active Control
The overall objective of this study is to assess the efficacy and safety of treatment with PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to very severe COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- GFF MDI, GP MDI, FF MDI, Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®), Placebo MDI
- 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 MDIDrug
GFF MDI administered as two puffs Bis in Di.e. Twice Daily (BID)
GP MDIDrug
GP MDI administered as two puffs BID
FF MDIDrug
FF MDI administered as two puffs BID
Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)Drug
Taken as 1 capsule daily containing 18 µg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)
Placebo MDIDrug
Inhaled placebo administered as two puffs BID
| Study group | Role | What they receive |
|---|---|---|
| GFF MDI | Experimental | Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) (PT003) Receives: Drug: GFF MDI |
| GP MDI | Experimental | Glycopyrronium (GP) MDI (PT001) Receives: Drug: GP MDI |
| FF MDI | Experimental | Formoterol Fumarate (FF) MDI (PT005) Receives: Drug: FF MDI |
| Open-label tiotropium bromide inhalation powder | Active comparator | Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®) Receives: Drug: Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®) |
| Placebo | Placebo comparator | Placebo MDI 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
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24
Measured: Baseline and at Week 24
Secondary outcomes (5)
Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) over 24 weeks. FEV1 was assessed at multiple time points post-baseline,and a modelbased average of all visits starting from Week 2 through week 24 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.
Measured: Baseline and Weeks 2 to 24
St. George's Respiratory Questionnaire (SGRQ) Score
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: Baseline and at Week 24
Rescue Ventolin Hydrofluoroalkane (HFA) Use
Change from baseline in average daily rescue Ventolin HFA use
Measured: Baseline and at Week 24
Onset of Action as Assessed by FEV1
Defined as the first time-point using the 5- and 15-minute post dose measurements where the difference in FEV1 from Placebo was statistically significant
Measured: Assessed for 5- and 15-minute post dose on Day 1
Peak Change From Baseline in FEV1 Within 2 Hours Post-dose
Peak change from baseline in forced expiratory volume in 1 second (FEV1) within 2 hours post-dose
Measured: Baseline and at Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startMay 2013
- Primary completionFeb 2015
- Study completionFeb 2015
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 (5)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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2,103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pearl Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Colin Reisner, MD, Study director, Pearl Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854645
- Sponsor's protocol ID
- PT003006-00
- Status last verified
- Feb 2017
- First submitted
- 13 May 2013
- Last updated
- 28 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Spata E, Jauhiainen A, Da Silva CA. Impact of season and geography on COPDCompEx: a composite endpoint for COPD trials. Respir Med Res. 2026 Jul 12;90:101305. doi: 10.1016/j.resmer.2026.101305. Online ahead of print.
PubMed 42551404Singh 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 35815359Martinez 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 32450869Martinez 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 32021148Martinez FJ, Fabbri LM, Ferguson GT, Orevillo C, Darken P, Martin UJ, Reisner C. Baseline Symptom Score Impact on Benefits of Glycopyrrolate/Formoterol Metered Dose Inhaler in COPD. Chest. 2017 Dec;152(6):1169-1178. doi: 10.1016/j.chest.2017.07.007. Epub 2017 Jul 16.
PubMed 28720336
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Chronic Dosing, 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 and Spiriva® Handihaler® (Tiotropium Bromide 18 µg Open-Label) as an Active Control
- ClinicalTrials.gov ID
- NCT01854645
- Acronym / sponsor ID
- PT003006-00
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,103 participants (actual)
- Lead sponsor
- Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 15 May 2013 (estimated)
- Results
- Posted 28 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this study is to assess the efficacy and safety of treatment with PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to very severe COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GFF MDI | Experimental | Drug: GFF MDIGlycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) (PT003) |
| GP MDI | Experimental | Drug: GP MDIGlycopyrronium (GP) MDI (PT001) |
| FF MDI | Experimental | Drug: FF MDIFormoterol Fumarate (FF) MDI (PT005) |
| Open-label tiotropium bromide inhalation powder | Active comparator | Drug: Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®) |
| Placebo | Placebo comparator | Drug: Placebo MDIPlacebo MDI |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects at least 40 years of age and no older than 80 at Visit 1.
- 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.
- Average f the -60 and the -30 min pre-dose FEV1 assessments must be < 80% predicted normal value calculated using National Health and Nutrition Examination Survey (NHANES) III reference equations.
- Subjects willing and, in the opinion of the investigator, able to adjust current COPD therapy as required by the protocol
Key exclusion criteria (14 listed)
- Significant diseases other than COPD, i.e. disease or condition which, in the opinion of the investigator, may put the patient 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
- Current diagnosis of asthma or alpha-1 antitrypsin deficiency
- Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea
- Hospitalized due to poorly controlled COPD within 3 months prior to screening or during the Screening Period
- Poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to screening or during the Screening Period
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 MDIGFF MDI administered as two puffs Bis in Di.e. Twice Daily (BID) | Drug | GFF MDI |
| GP MDIGP MDI administered as two puffs BID | Drug | GP MDI |
| FF MDIFF MDI administered as two puffs BID | Drug | FF MDI |
| Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)Taken as 1 capsule daily containing 18 µg of open-label tiotropium via the Handihaler dry powder inhaler (DPI) | Drug | Open-label tiotropium bromide inhalation powder |
| Placebo MDIInhaled placebo administered as two puffs BID | Drug | Placebo |
Primary outcome
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24
Time frame: Baseline and at Week 24
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24
5 secondary outcomes
Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks
Time frame: Baseline and Weeks 2 to 24
St. George's Respiratory Questionnaire (SGRQ) Score
Time frame: Baseline and at Week 24
Rescue Ventolin Hydrofluoroalkane (HFA) Use
Time frame: Baseline and at Week 24
Onset of Action as Assessed by FEV1
Time frame: Assessed for 5- and 15-minute post dose on Day 1
Peak Change From Baseline in FEV1 Within 2 Hours Post-dose
Time frame: Baseline and at Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42551404Spata E, Jauhiainen A, Da Silva CA. Impact of season and geography on COPDCompEx: a composite endpoint for COPD trials. Respir Med Res. 2026 Jul 12;90:101305. doi: 10.1016/j.resmer.2026.101305. Online ahead of print.
- 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 28720336Martinez FJ, Fabbri LM, Ferguson GT, Orevillo C, Darken P, Martin UJ, Reisner C. Baseline Symptom Score Impact on Benefits of Glycopyrrolate/Formoterol Metered Dose Inhaler in COPD. Chest. 2017 Dec;152(6):1169-1178. doi: 10.1016/j.chest.2017.07.007. Epub 2017 Jul 16.
- PT003006-02 Protocol and Amendment-FINAL-RedactedLink provided by the sponsor.
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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 director
Pearl Therapeutics, Inc.
139 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GFF MDI, GP MDI and FF MDI in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 139 sites in 3 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 14 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 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 139 sites in United States, Australia, New Zealand. 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 28 Mar 2017). 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 (time frame: Baseline and at Week 24). 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 NCT01854645, which also lists 5 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 28 Mar 2017.