COPDPhase 3NCT02347072

24-hour Lung Function in Subjects With Moderate to Very Severe COPD After Treatment With PT003, Open-Label Spiriva® Respimat® as an Active Control, and Placebo

A Phase 3 study testing GFF MDI (PT003) and Spiriva® Respimat® (Tiotropium Bromide) in people with COPD, run by Pearl Therapeutics, Inc..

Completed

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

Official record

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Trial summary

Randomized, Phase IIIb, Three-period, Three-treatment, Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe COPD after 4 Weeks of Treatment with PT003, Open-Label Spiriva® Respimat® (Tiotropium Bromide) as an Active Control, and Placebo. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: COPD
What is being tested?: GFF MDI (PT003) and Spiriva® Respimat® (Tiotropium Bromide)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: No sites listed yet
Study dates: 1 Feb 2015to 1 Mar 2016
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

At least 40 years of age and no older than 80 at Screening
Women of non-child bearing potential or negative serum pregnancy test at Screening, and agrees to acceptable contraceptive methods used consistently and correctly Screening until 14 days after final visit.
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
Pre- and post-bronchodilator FEV1/FVC ratio of <0.70
Post-bronchodilator FEV1 must be <80% predicted normal value, calculated using NHANES III reference equations, and the measured FEV1 must also be ≥750 mL if FEV1 <30% of predicted normal value.

Who cannot join

Significant diseases other than COPD, i.e., 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.
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 Screening or during the Screening Period.
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 Screening or during the Screening Period.
Subjects who have clinically significant uncontrolled hypertension.

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Subjects who have cancer that has not been in complete remission for at least five years.
Subjects with abnormal liver function tests defined as AST, ALT, or total bilirubin ≥1.5 times upper limit of normal at Screening and on repeat testing.
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 with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the Investigator. Subjects with a trans-urethral resection of prostate (TURP) or full resection of the prostate within 6 months prior to Screening are excluded from the study.
Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator.

About this study

Official title: A Randomized, Phase IIIb, Three-period, Three-treatment, Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects With Moderate to Very Severe COPD After 4 Weeks of Treatment With PT003, Open-Label Spiriva® Respimat® (Tiotropium Bromide) as an Active Control, and Placebo

Conditions: COPD
Being tested: GFF MDI (PT003), Placebo MDI, Spiriva® Respimat® (Tiotropium Bromide)
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 Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)
Placebo MDIDrug
Also called Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol
Spiriva® Respimat® (Tiotropium Bromide)Drug
Tiotropium Bromide Inhalation Solution; Spiriva® Respimat® (Spiriva)

Study groups in NCT02347072
Study group	Role	What they receive
GFF MDI (PT003)	Experimental	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) Receives: Drug: GFF MDI (PT003)
Placebo MDI	Placebo comparator	Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol Receives: Drug: Placebo MDI
Spiriva® Respimat® (Tiotropium Bromide)	Active comparator	Tiotropium Bromide Inhalation Solution; Spiriva® Respimat® (Spiriva) Receives: Drug: Spiriva® Respimat® (Tiotropium Bromide)

What is being measured

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

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

Secondary outcomes (8)

FEV1 AUC12-24
Normalized FEV1 AUC12-24
Measured: Pre dose, 15 and 30 minutes, 1, 2, 4, 8, and 12 hours post the evening dose on Day 29
FEV1 AUC0-12
Normalized FEV1 AUC0-12
Measured: Pre dose, 15 and 30 minutes, 1, 2, 4, 8, and 12 hours post the morning dose on Day 29
Peak Change From Baseline in FEV1 Evening
Peak Change From Baseline in FEV1 Evening
Measured: Baseline and Day 29
Peak Change From Baseline in FEV1 Morning
Peak Change From Baseline in FEV1 Morning
Measured: Baseline and Day 29
Morning Pre-Dose Trough FEV1 on Day 29
Morning Pre-Dose Trough FEV1 on Day 29
Measured: Day 29
Morning Pre-Dose Trough FEV1 on Day 30
Morning Pre-Dose Trough FEV1 on Day 30
Measured: Day 30
Peak Change From Baseline in IC (Inspiratory Capacity) Evening
Peak Change From Baseline in IC Evening
Measured: Baseline and Day 29
Peak Change From Baseline in IC Morning
Peak Change From Baseline in IC Morning
Measured: Baseline and Day 29

Timeline

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

1 Feb 20151 Mar 2016

First posted27 Jan 2015 (estimated)
Study start1 Feb 2015
Primary completion1 Aug 2015
Study completion1 Mar 2016

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 COPDStudies 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: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02347072
Sponsor's protocol ID: PT003011-00
Status last verified: Mar 2017
First submitted: 21 Jan 2015
Last updated: 19 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Reisner C, Gottschlich G, Fakih F, Koser A, Krainson J, Delacruz L, Arora S, Feldman G, Pudi K, Siddiqui S, Orevillo C, Maes A, St Rose E, Martin U. 24-h bronchodilation and inspiratory capacity improvements with glycopyrrolate/formoterol fumarate via co-suspension delivery technology in COPD. Respir Res. 2017 Aug 18;18(1):157. doi: 10.1186/s12931-017-0636-4.
PubMed 28821260

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?

Official record

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All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Phase IIIb, Three-period, Three-treatment, Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects With Moderate to Very Severe COPD After 4 Weeks of Treatment With PT003, Open-Label Spiriva® Respimat® (Tiotropium Bromide) as an Active Control, and Placebo
ClinicalTrials.gov ID: NCT02347072
Acronym / sponsor ID: PT003011-00
Conditions: COPD
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 1 Feb 2015 (actual)
Primary completion: 1 Aug 2015 (actual)
Study completion: 1 Mar 2016 (actual)
First posted: 27 Jan 2015 (estimated)
Results: Posted 19 Apr 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: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
GFF MDI (PT003)	Experimental	Drug: GFF MDI (PT003)Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)
Placebo MDI	Placebo comparator	Drug: Placebo MDIPlacebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol
Spiriva® Respimat® (Tiotropium Bromide)	Active comparator	Drug: Spiriva® Respimat® (Tiotropium Bromide)Tiotropium Bromide Inhalation Solution; Spiriva® Respimat® (Spiriva)

Who may qualify

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

Key inclusion criteria (6 listed)

At least 40 years of age and no older than 80 at Screening
Women of non-child bearing potential or negative serum pregnancy test at Screening, and agrees to acceptable contraceptive methods used consistently and correctly Screening until 14 days after final visit.
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
Pre- and post-bronchodilator FEV1/FVC ratio of <0.70

Key exclusion criteria (11 listed)

Significant diseases other than COPD, i.e., 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.
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 Screening or during the Screening Period.
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 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 (PT003)Also: Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)	Drug	GFF MDI (PT003)
Placebo MDIAlso: Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol	Drug	Placebo MDI
Spiriva® Respimat® (Tiotropium Bromide)Tiotropium Bromide Inhalation Solution; Spiriva® Respimat® (Spiriva)	Drug	Spiriva® Respimat® (Tiotropium Bromide)

Primary outcome

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

8 secondary outcomes

FEV1 AUC12-24
Time frame: Pre dose, 15 and 30 minutes, 1, 2, 4, 8, and 12 hours post the evening dose on Day 29
FEV1 AUC0-12
Time frame: Pre dose, 15 and 30 minutes, 1, 2, 4, 8, and 12 hours post the morning dose on Day 29
Peak Change From Baseline in FEV1 Evening
Time frame: Baseline and Day 29
Peak Change From Baseline in FEV1 Morning
Time frame: Baseline and Day 29
Morning Pre-Dose Trough FEV1 on Day 29
Time frame: Day 29
Morning Pre-Dose Trough FEV1 on Day 30
Time frame: Day 30
Peak Change From Baseline in IC (Inspiratory Capacity) Evening
Time frame: Baseline and Day 29
Peak Change From Baseline in IC Morning
Time frame: Baseline and Day 29

Results and safety

Results posted to the registry on 19 Apr 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
Overall Study	80	62

Primary outcome: Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-24

Time frame: Pre dose, 15 and 30 minutes, 1, 2, 4, 8, 12, 12.25, 12.5, 13, 14, 16, 22, and 24 hours post the morning dose on Day 29. Least squares mean (95% Confidence Interval). Unit: Liters

Measure	GFF MDI n = 65	Spiriva Respimat n = 67	Placebo n = 65
Value	0.192 (0.141 to 0.243)	0.112 (0.061 to 0.162)	-0.072 (-0.123 to -0.022)

Population analysed: Subjects in the Modified Intent to Treat (MITT) Population who had a sufficient number of post dose FEV1 measurements

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GFF MDI	2 of 75 (2.7%)	5 of 75 (6.7%)	Not reported
Spiriva Respimat	2 of 73 (2.7%)	5 of 73 (6.8%)	Not reported
Placebo	2 of 72 (2.8%)	6 of 72 (8.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28821260Reisner C, Gottschlich G, Fakih F, Koser A, Krainson J, Delacruz L, Arora S, Feldman G, Pudi K, Siddiqui S, Orevillo C, Maes A, St Rose E, Martin U. 24-h bronchodilation and inspiratory capacity improvements with glycopyrrolate/formoterol fumarate via co-suspension delivery technology in COPD. Respir Res. 2017 Aug 18;18(1):157. doi: 10.1186/s12931-017-0636-4.

Related trials for COPD

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GFF MDI (PT003) and Spiriva® Respimat® (Tiotropium Bromide) in people with COPD, run by Pearl Therapeutics, Inc..

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 11 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 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

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 19 Apr 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?

Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-24 (time frame: Pre dose, 15 and 30 minutes, 1, 2, 4, 8, 12, 12.25, 12.5, 13, 14, 16, 22, and 24 hours post the morning dose on Day 29). 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 NCT02347072, 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 19 Apr 2017.