COPDPhase 3NCT02268396

Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) Dose Indicator Study in Adults With Moderate to Very Severe COPD

A Phase 3 study testing Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler in people with COPD, run by Pearl Therapeutics, Inc. at 10 sites in United States.

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

This is an open-label, multi-center study to evaluate the accuracy, reliability and functionality of the Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) dose indicator in adult subjects with moderate to very severe COPD over a 4-week Treatment Period. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: COPD
What is being tested?: Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 138 participants
Where: 10 sitesUnited States
Study dates: Nov 2014to May 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

Give their signed written informed consent to participate.
Are at least 40 years of age and no older than 80 at Visit 1.
A female of non-child bearing potential or child bearing potential, has a negative serum pregnancy test, and agrees to approved contraceptive methods.
COPD Diagnosis: 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.
FEV1/FVC ratio of <0.70.
Post-bronchodilator FEV1 must be ≥ 30% and <80% predicted normal value calculated using the Third National Health and Nutrition Examination Survey (NHANES III) reference equations, and must also be greater than or equal to 750 mL.
Subject is willing and, in the opinion of the Investigator, able to adjust current COPD therapy as required by the protocol.

Who cannot join

Pregnancy, nursing females or subjects trying to conceive.
Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study.
Current primary diagnosis of asthma.
History of ECG abnormalities.
Poorly controlled or worsening COPD prior to Screening or during the Screening Period.
Clinically significant bladder neck obstruction or urinary retention.

Show all 10Show fewer

Male subjects with a trans-urethral resection of prostate (TURP) or full resection of the prostate within 6 months prior to Screening.
Cancer that has not been in complete remission for at least five years.
Inadequately treated glaucoma.
History of allergic reaction or hypersensitivity to any component of the formulations used in this study.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Pearl Investigative Site
Charlotte, North Carolina
Pearl Investigative Site
Clearwater, Florida
Pearl Investigative Site
Columbus, Ohio
Pearl Investigative Site
Greenville, South Carolina
Pearl Investigative Site
Medford, Oregon
Pearl Investigative Site
Richmond, Virginia
Pearl Investigative Site
Rock Hill, South Carolina
Pearl Investigative Site
Spartanburg, South Carolina
Pearl Investigative Site
Tampa, Florida
Pearl Investigative Site
Winter Park, Florida

Other trials in United States

About this study

Official title: An Open-Label, Multi-Center, Dose Indicator Study of Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) in Adult Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Conditions: COPD
Being tested: Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler
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.

Glycopyrronium and Formoterol Fumarate Metered-dose InhalerDrug
Also called GFF MDI, PT003
GFF MDI administered as 2 inhalations BID

Study groups in NCT02268396
Study group	Role	What they receive
Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler	Experimental	Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler (GFF MDI), PT003 Receives: Drug: Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler

What is being measured

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

Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count
Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit: ITT Population
Measured: Over the life of the canister/120 puffs - up to 4 weeks

Secondary outcomes (5)

Percentage of Devices in Agreement Between eCRF-Based Dose Indicator Actuation Count and Weight-Based Actuation Count at the Last Available Visit
Percentage of devices whose number of actuations counted at the end of the study, using the dose indicator reading, was consistent (±20 actuations) with the number of actuations used as estimated by the change in MDI weight
Measured: Over the life of the canister/120 puffs - up to 4 weeks
Percentage of Devices in Agreement Between Laboratory-Advanced Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit
Percentage of devices whose number of actuations counted at the end of the study, using the lab-advanced dose indicator reading, was consistent (±20 actuations) with the number of actuations used as reported by the subject
Measured: Over the life of the canister/120 puffs - up to 4 weeks
Percentage of Devices in Agreement Between Laboratory-advanced Does Indicator Actuation and Weight-based Actuation Count at Last Available Visit.
Percentage of devices whose number of actuations counted at the end of the study, using the dose indicator reading, was consistent (±20 actuations) with the number of actuations used as estimated by the change in MDI weight
Measured: Over the life of the canister/120 puffs - up to 4 weeks
Percentage of Devices Where the Dose Indicator Actuation Count is >20 Less Than the Subject-reported Actuation Count (Undercount)
Percentage of devices where the dose indicator actuation count is >20 less than the subject-reported actuation count (undercount)
Measured: Over the life of the canister/120 puffs - up to 4 weeks
Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count
Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count
Measured: Over the life of the canister/120 puffs - up to 4 weeks

Timeline

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

Nov 2014May 2015

First posted20 Oct 2014 (estimated)
Study startNov 2014
Primary completionJan 2015
Study completionMay 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 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 138 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02268396
Sponsor's protocol ID: PT003016-00
Status last verified: Oct 2016
First submitted: 15 Oct 2014
Last updated: 23 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Pudi K, Feldman G, Fakih F, Mack P, Maes A, Siddiqui S, St Rose E, Reisner C. An Open-Label Study Evaluating the Performance of the Dose Indicator in a Metered Dose Inhaler Delivering Glycopyrrolate and Formoterol Fumarate in Patients with Moderate-to-Very Severe Chronic Obstructive Pulmonary Disease. J Aerosol Med Pulm Drug Deliv. 2019 Feb;32(1):40-46. doi: 10.1089/jamp.2018.1466. Epub 2018 Nov 1.
PubMed 30335559

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 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multi-Center, Dose Indicator Study of Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) in Adult Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT02268396
Acronym / sponsor ID: PT003016-00
Conditions: COPD
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 138 participants (actual)
Lead sponsor: Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2014
Primary completion: Jan 2015 (actual)
Study completion: May 2015 (actual)
First posted: 20 Oct 2014 (estimated)
Results: Posted 23 Dec 2016

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler	Experimental	Drug: Glycopyrronium and Formoterol Fumarate Metered-dose InhalerGlycopyrronium and Formoterol Fumarate Metered-dose Inhaler (GFF MDI), PT003

Who may qualify

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

Key inclusion criteria (8 listed)

Give their signed written informed consent to participate.
Are at least 40 years of age and no older than 80 at Visit 1.
A female of non-child bearing potential or child bearing potential, has a negative serum pregnancy test, and agrees to approved contraceptive methods.
COPD Diagnosis: 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.

Key exclusion criteria (10 listed)

Pregnancy, nursing females or subjects trying to conceive.
Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study.
Current primary diagnosis of asthma.
History of ECG abnormalities.
Poorly controlled or worsening COPD 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
Glycopyrronium and Formoterol Fumarate Metered-dose InhalerAlso: GFF MDI, PT003GFF MDI administered as 2 inhalations BID	Drug	Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler

Primary outcome

Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count
Time frame: Over the life of the canister/120 puffs - up to 4 weeks
Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit: ITT Population

5 secondary outcomes

Percentage of Devices in Agreement Between eCRF-Based Dose Indicator Actuation Count and Weight-Based Actuation Count at the Last Available Visit
Time frame: Over the life of the canister/120 puffs - up to 4 weeks
Percentage of Devices in Agreement Between Laboratory-Advanced Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit
Time frame: Over the life of the canister/120 puffs - up to 4 weeks
Percentage of Devices in Agreement Between Laboratory-advanced Does Indicator Actuation and Weight-based Actuation Count at Last Available Visit.
Time frame: Over the life of the canister/120 puffs - up to 4 weeks
Percentage of Devices Where the Dose Indicator Actuation Count is >20 Less Than the Subject-reported Actuation Count (Undercount)
Time frame: Over the life of the canister/120 puffs - up to 4 weeks
Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count
Time frame: Over the life of the canister/120 puffs - up to 4 weeks

Results and safety

Results posted to the registry on 23 Dec 2016, 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)	138	126

Primary outcome: Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count

Time frame: Over the life of the canister/120 puffs - up to 4 weeks. Number. Unit: Percentage

Measure	GFF MDI (PT003) n = 137
Value	96.4 (18.9)

Population analysed: ITT Population

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs occurring between when signed consent and randomized reported as SAEs up to 14 days following last dose of study drug. AEs occurring at time of and following first study drug administration were reported and followed until stabilized/resolved.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GFF MDI (PT003)	3 of 138 (2.2%)	10 of 138 (7.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30335559Pudi K, Feldman G, Fakih F, Mack P, Maes A, Siddiqui S, St Rose E, Reisner C. An Open-Label Study Evaluating the Performance of the Dose Indicator in a Metered Dose Inhaler Delivering Glycopyrrolate and Formoterol Fumarate in Patients with Moderate-to-Very Severe Chronic Obstructive Pulmonary Disease. J Aerosol Med Pulm Drug Deliv. 2019 Feb;32(1):40-46. doi: 10.1089/jamp.2018.1466. Epub 2018 Nov 1.

Related trials for COPD

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
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

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

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler in people with COPD, run by Pearl Therapeutics, Inc. at 10 sites in United States.

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 8 inclusion and 10 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 23 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. 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 23 Dec 2016). 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?

Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count (time frame: Over the life of the canister/120 puffs - up to 4 weeks). 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 NCT02268396, 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 23 Dec 2016.