Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT01970878

Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® (PINNACLE 3)

A Phase 3 study testing GFF MDI (PT 003), GP MDI (PT001) and FF MDI (PT005) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Pearl Therapeutics, Inc. at 125 sites in 3 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

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease (COPD)
What is being tested?: GFF MDI (PT 003), GP MDI (PT001) and FF MDI (PT005)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 892 participants
Where: 125 sitesin 3 countries
Study dates: Nov 2013to Mar 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

Participant in/completion of previous 24-week PINNACLE Phase III Trial.
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.
Subjects with FEV1/forced vital capacity (FVC) ratio of <0.70 and FEV1 <80% predicted normal and ≥750 mL if FEV1 <30% of predicted normal value.
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 electrocardiogram (ECG)
Abnormal liver function tests defined as alanine transaminase (ALT), aspartate transaminanse (AST), 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

125 sites in 3 countries.

Country

City, postcode or hospital

125 sites in 3 countries

United States110 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
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
Bellvue, Nebraska
Pearl Investigative Site
Bend, Oregon
Pearl Investigative Site
Birmingham, Alabama
Pearl Investigative Site
Brandon, Oregon
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
Chesterfield, Missouri
Pearl Investigative Site
Cincinnati, Ohio
Pearl Investigative Site
Clearwater, Florida
Pearl Investigative Site
Colorado Springs, Colorado
Pearl Investigative Site
Columbus, Georgia
Pearl Investigative Site
Corning, New York
Pearl Investigative Site
Couer D'aline, Idaho
Pearl Investigative Site
Danbury, Connecticut
Pearl Investigative Site
Dayton, Ohio
Pearl Investigative Site
Denver, Colorado
Pearl Investigative Site
Duluth, Georgia
Pearl Investigative Site
Easley, South Carolina
Pearl Investigative Site
Edina, Minnesota
Pearl Investigative Site
Evanston, Illinois
Pearl Investigative Site
Evansville, Indiana
Pearl Investigative Site
Fort Collins, Colorado
Pearl Investigative Site
Fridley, Minnesota
Pearl Investigative Site
Gaffney, South Carolina
Pearl Investigative Site
Gainesville, Georgia
Pearl Investigative Site
Glendale, Arizona
Pearl Investigative Site
Greensboro, North 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
Jasper, Alabama
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
Livonia, Michigan
Pearl Investigative Site
Longview, Texas
Pearl Investigative Site
Los Angeles, California
Pearl Investigative Site
Louisville, Kentucky
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
Monterey Park, California
Pearl Investigative Site
Mooresville, North Carolina
Pearl Investigative Site
Morgantown, West Virginia
Pearl Investigative Site
Murrells Inlet, South Carolina
Pearl Investigative Site
New Braunfels, Texas
Pearl Investigative Site
Olathe, Kansas
Pearl Investigative Site
Omaha, Nebraska
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
Pittsburgh, Pennsylvania
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
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 Bend, Indiana
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
Tustin, California
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

Other trials in United States

Australia9 sites

Pearl Investigative Site
Adelaide, South Australia
Pearl Investigative Site
Brisbane, Queensland
Pearl Investigative Site
Cairns, Queensland
Pearl Investigative Site
Heidelberg, Victoria
Pearl Investigative Site
Nederlands, Western Australia
Pearl Investigative Site
New Lambton, New South Wales
Pearl Investigative Site
Perth, Western Australia
Pearl Investigative Site
Westmead, New South Wales
Pearl Investigative Site
Wooloongabba, Queensland

Other trials in Australia

New Zealand6 sites

Pearl Investigative Site
Caversham, Dunedin
Pearl Investigative Site
Greenlabe, East Aukland
Pearl Investigative Site
Hamilton, Waikato Region
Pearl Investigative Site
Newtown, Wellington Region
Pearl Investigative Site
Otahuhu, Aukland
Pearl Investigative Site
Tauranga

Other trials in New Zealand

About this study

Official title: A 28-Week, Multi-Center, Randomized, Double Blind, Parallel-Group, Active-Controlled Safety Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® as an Active Control

This is a multi-center, randomized, double-blind, parallel group, chronic dosing, active-controlled, 28-week safety extension study of the two pivotal 24-week safety and efficacy studies (Studies PT003006 and PT003007). This study is designed to assess the long-term safety and tolerability of Glycopyrrolate (GP) and Formoterol Fumarate (FF) combination (GFF) metered dose inhaler (MDI), GP MDI, and FF MDI in subjects with moderate to very severe COPD over a total observation period of 52 weeks. Open-label Spiriva is included as an active control. To be eligible for this study, a subject must complete participation in Study PT003006 (NCT01854645) or Study PT003007 (NCT01854658).

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: GFF MDI (PT 003), GP MDI (PT001), FF MDI (PT005), Open-label tiotropium bromide inhalation (Spiriva® Handihaler®)
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 (PT 003)Drug
GFF MDI administered as two puffs BID
GP MDI (PT001)Drug
GP MDI administered as two puffs BID
FF MDI (PT005)Drug
FF MDI administered as two puffs BID
Open-label tiotropium bromide inhalation (Spiriva® Handihaler®)Drug
Taken as 1 capsule daily containing 18 μg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)

Study groups in NCT01970878
Study group	Role	What they receive
GFF MDI (PT003)	Experimental	Not described Receives: Drug: GFF MDI (PT 003)
GP MDI (PT001)	Experimental	Not described Receives: Drug: GP MDI (PT001)
FF MDI (PT005)	Experimental	Not described Receives: Drug: FF MDI (PT005)
Open-label tiotropium bromide inhalation powder	Active comparator	Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®) Receives: Drug: Open-label tiotropium bromide inhalation (Spiriva® Handihaler®)

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 Over 52 Weeks
Change From Baseline in Morning Pre-Dose Trough FEV1 Over 52 Weeks as a Model-Based Average (ITT Population). FEV1 was assessed at multiple time points post-baseline, and a model-based average of all visits starting from Week 2 through week 52 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 52

Secondary outcomes (4)

Self-Administered Computerized (SAC) TDI Focal Score Over 52 Weeks
SAC TDI focal score over 52 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: Baseline and Weeks 4 to 52
Peak Change From Baseline in FEV1 Within 2 Hrs Post-dosing
Peak change from Baseline FEV1 Over 52 Weeks is a Model-Based Average (ITT Population). Peak FEV1 was assessed at multiple visits post-baseline, and a model-based average of all visits starting from Week 2 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average Peak FEV1 post-baseline.
Measured: Baseline and Weeks 2 to 52
Change From Baseline in 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 (best possible health status) to 100 (worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life. SGRQ Total Score was assessed at multiple visits post-baseline, and a model-based average of all visits starting from Week 12 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average SGRQ Total Score post-baseline.
Measured: Baseline and Weeks 12 to 52
Change From Baseline in Average Daily Rescue Ventolin Use
Subjects recorded in their diary the number of puffs of rescue Ventolin HFA taken on each study day. The subject's average daily number of puffs of rescue Ventolin HFA was calculated over the entire 52-week treatment period. Missing values were ignored in both the numerator and denominator. Diary data recorded during the last 7 days of the 10-14 day screening period were used to calculate the baseline average. Change in rescue Ventolin HFA use was calculated by subtracting the baseline average from the 52-week average.
Measured: Baseline through Week 52

Timeline

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

Nov 2013Mar 2015

First posted28 Oct 2013 (estimated)
Study startNov 2013
Primary completionMar 2015
Study completionMar 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 (1)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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: 892 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01970878
Sponsor's protocol ID: PT003008-00
Status last verified: Feb 2017
First submitted: 18 Oct 2013
Last updated: 17 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

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

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Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 28-Week, Multi-Center, Randomized, Double Blind, Parallel-Group, Active-Controlled Safety Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® as an Active Control
ClinicalTrials.gov ID: NCT01970878
Acronym / sponsor ID: PT003008-00
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 892 participants (actual)
Lead sponsor: Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2013
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 28 Oct 2013 (estimated)
Results: Posted 6 Feb 2017

Clinical summary

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

Study design

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

Arm	Type	Receives
GFF MDI (PT003)	Experimental	Drug: GFF MDI (PT 003)
GP MDI (PT001)	Experimental	Drug: GP MDI (PT001)
FF MDI (PT005)	Experimental	Drug: FF MDI (PT005)
Open-label tiotropium bromide inhalation powder	Active comparator	Drug: Open-label tiotropium bromide inhalation (Spiriva® Handihaler®)Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)

Who may qualify

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

Key inclusion criteria (6 listed)

Participant in/completion of previous 24-week PINNACLE Phase III Trial.
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.
Subjects with FEV1/forced vital capacity (FVC) ratio of <0.70 and FEV1 <80% predicted normal and ≥750 mL if FEV1 <30% of predicted normal value.

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 MDI (PT 003)GFF MDI administered as two puffs BID	Drug	GFF MDI (PT003)
GP MDI (PT001)GP MDI administered as two puffs BID	Drug	GP MDI (PT001)
FF MDI (PT005)FF MDI administered as two puffs BID	Drug	FF MDI (PT005)
Open-label tiotropium bromide inhalation (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

Primary outcome

Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks
Time frame: Baseline and Weeks 2 to 52
Change From Baseline in Morning Pre-Dose Trough FEV1 Over 52 Weeks as a Model-Based Average (ITT Population). FEV1 was assessed at multiple time points post-baseline, and a model-based average of all visits starting from Week 2 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.

4 secondary outcomes

Self-Administered Computerized (SAC) TDI Focal Score Over 52 Weeks
Time frame: Baseline and Weeks 4 to 52
Peak Change From Baseline in FEV1 Within 2 Hrs Post-dosing
Time frame: Baseline and Weeks 2 to 52
Change From Baseline in SGRQ Total Score
Time frame: Baseline and Weeks 12 to 52
Change From Baseline in Average Daily Rescue Ventolin Use
Time frame: Baseline through Week 52

Results and safety

Results posted to the registry on 6 Feb 2017, 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 (PT003)	290	253
GP MDI (PT001)	218	191
FF MDI (PT005)	213	187
Spiriva® Handihaler® (Open-label)	171	147

Primary outcome: Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks

Time frame: Baseline and Weeks 2 to 52. Least squares mean (95% Confidence Interval). Unit: Liters

Measure	GFF MDI (PT003) n = 1021	GP MDI (PT001) n = 872	FF MDI (PT005) n = 871	Spiriva® Handihaler® (Open-label) n = 445
Value	0.133 (0.122 to 0.144)	0.076 (0.064 to 0.088)	0.068 (0.056 to 0.080)	0.107 (0.091 to 0.124)

Population analysed: Subjects in the ITT population from the lead-in studies who had data for the parameter.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 52 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GFF MDI (PT003)	114 of 1,036 (11%)	109 of 1,036 (10.5%)	Not reported
GP MDI (PT001)	90 of 890 (10.1%)	77 of 890 (8.7%)	Not reported
FF MDI (PT005)	78 of 890 (8.8%)	90 of 890 (10.1%)	Not reported
Spiriva® Handihaler® (Open-label)	49 of 451 (10.9%)	51 of 451 (11.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
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.

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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 chair

Pearl Therapeutics, Inc.

125 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 (PT 003), GP MDI (PT001) and FF MDI (PT005) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Pearl Therapeutics, Inc. at 125 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 6 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 17 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 125 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. 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 6 Feb 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 Over 52 Weeks (time frame: Baseline and Weeks 2 to 52). 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 NCT01970878, which also lists 1 linked publication.

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 17 Mar 2017.