Chronic Obstructive Pulmonary DiseasePhase 2NCT01085045

Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2 study testing PT003 MDI, PT005 MDI and Tiotropium bromide 18 μg (Spiriva Handihaler®) in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 16 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

The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of the components… 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?: PT003 MDI, PT005 MDI and Tiotropium bromide 18 μg (Spiriva Handihaler®)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 118 participants
Where: 16 sitesin 3 countries
Study dates: Mar 2010to Nov 2010
Phase: Phase 2
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

Signed written informed consent
40 - 80 years of age
Clinical history of COPD with airflow limitation that is not fully reversible
Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
Current/former smokers with at least a 10 pack-year history of cigarette smoking
A measured post- bronchodilator FEV1/FVC ratio of < or = 0.70
A measured post- bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of predicted normal values
Able to change COPD treatment as required by protocol

Who cannot join

Women who are pregnant or lactating
Primary diagnosis of asthma
Alpha-1 antitrypsin deficiency as the cause of COPD
Active pulmonary diseases
Prior lung volume reduction surgery
Abnormal chest X-ray (or CT scan) not due to the presence of COPD

Show all 11Show fewer

Hospitalized due to poorly controlled COPD within 3 months of Screening
Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
Cancer that has not been in complete remission for at least 5 years
Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives
Other protocol defined inclusion/exclusion criteria may apply

Trial locations and contacts

16 sites in 3 countries.

Country

City, postcode or hospital

16 sites in 3 countries

Australia8 sites

Respiratory Research Foundation - Burnside War Memorial Hospital
Adelaide, South Australia
Austrials
Auchenflower, Queensland, 4066
Austrials
Caringbah, New South Wales, 2229
Monash Medical Centre
Clayton, Victoria, 3168
Woolcock
Glebe, New South Wales, 2037
Q-Pharm
Herston, Queensland, 4006
Austrials
Hornsby, New South Wales, 2077
Lung Institute of WA
Nedlands, Western Australia, 6006

Other trials in Australia

United States4 sites

American Health Research
Charlotte, North Carolina, 28207
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, 97504
Spartanburg Medical Research
Spartanburg, South Carolina, 29303

Other trials in United States

New Zealand4 sites

P3 Research
Crofton Downs, Wellington Region, 6143
Greenlane Clinical Centre
Epsom, Auckland, 1051
NZ Respiratory & Sleep Institute
Greenlane East, Auckland, 1051
Waikato Hospital
Hamilton, Waikato Region, 3240

Other trials in New Zealand

About this study

Official title: A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (7 Days), Four-Period, Eight-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Two Doses of PT003, Two Doses of PT005 and One Dose of PT001 in Patients With Moderate to Very Severe COPD, Compared With Foradil® Aerolizer® (12 μg, Open-Label) and Spiriva® Handihaler® (18 μg, Open-Label) as Active Controls

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: PT003 MDI, PT005 MDI, Placebo MDI, Tiotropium bromide 18 μg (Spiriva Handihaler®), Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Keywords: COPD
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

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

PT003 MDIDrug
Inhaled PT003 MDI administered as two puffs BID for 7 days
PT005 MDIDrug
Inhaled PT005 MDI administered as two puffs BID for 7 days
Placebo MDIDrug
Inhaled placebo administered as two puffs BID for 7 days
Tiotropium bromide 18 μg (Spiriva Handihaler®)Drug
Inhaled tiotropium bromide 18 μg (Spiriva Handihaler®) administered QD for 7 days
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)Drug
Inhaled formoterol fumarate 12 μg (Foradil® Aerolizer®) administered BID for 7 days
PT001 MDIDrug
Inhaled PT001 MDI administered as two puffs BID for 7 days

Study groups in NCT01085045
Study group	Role	What they receive
Inhaled PT003 (Dose 1)	Experimental	PT003 MDI Dose 1 Receives: Drug: PT003 MDI
Inhaled PT003 (Dose 2)	Experimental	PT003 MDI Dose 2 Receives: Drug: PT003 MDI
Inhaled PT005 (Dose 1)	Experimental	PT005 MDI Dose 1 Receives: Drug: PT005 MDI
Inhaled PT005 (Dose 2)	Experimental	PT005 MDI Dose 2 Receives: Drug: PT005 MDI
Inhaled Placebo	Placebo comparator	Placebo MDI Receives: Drug: Placebo MDI
Tiotropium bromide 18 μg (Spiriva Handihaler®)	Active comparator	Tiotropium Bromide inhalation powder Receives: Drug: Tiotropium bromide 18 μg (Spiriva Handihaler®)
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)	Active comparator	Formoterol fumarate inhalation powder 12 μg Receives: Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Inhaled PT001 (Dose 1)	Experimental	PT001 MDI Dose 1 Receives: Drug: PT001 MDI

What is being measured

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

FEV1 AUC 0-12 on Day 7
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 (normalized) relative to baseline FEV1 following 7-day dose administration
Measured: "Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 11.5, and 12 hours post-dose on Day 7

Secondary outcomes (12)

Peak Change From BL in FEV1 on Day 1
Peak change from Baseline in FEV1 on Day 1
Measured: Day 1
Peak Change From BL in FEV1 on Day 7
Peak change from Baseline (BL) in FEV1 on Day 7
Measured: Day 7
Peak Change From BL in Inspiratory Capacity on Day 1
Peak change from Baseline in Inspiratory Capacity (IC) on Day 1
Measured: Day 1
Peak Change From BL IC on Day 7
Peak Change from Baseline Inspiratory Capacity on following 7-day dose administration
Measured: Day 7
Time to Onset of Action >=10% Improvement in FEV1 on Day 1
Time to Onset of Action where the improvement in FEV1 on Day 1 was >=10%
Measured: Day 1
Percentage of Patients Achieving >=12% Improvement in FEV1 on Day 1
Time to Onset of Action where the improvement in FEV1 on Day 1 was >= 12%
Measured: Day 1
Change in Morning Pre-dose FEV1 on Day 7
Change from Baseline in morning pre-dose FEV1 on Day 7
Measured: Day 7
12 hr Post-dose Trough FEV1 on Day 7
12 hour post-dose trough Forced Expiratory Volume in 1 second on Day 7
Measured: Day 7
Change From BL in Mean Morning Pre-dose Daily Peak Flow Rate on Day 7
Change from BaseLine in mean morning pre-dose daily peak flow rate on Day 7
Measured: Day 7
Change From BL in Mean Morning Post-dose Daily Peak Flow Rate on Day 7
Change from BaseLine in mean morning post-dose daily peak flow rate on Day 7
Measured: Day 7
Change From BL in Mean Evening Pre-dose Daily Peak Flow Rate on Day 7
Change from BaseLine in mean evening pre-dose daily peak flow rate on Day 7
Measured: Day 7
Change From BL in Mean Evening Post-dose Daily Peak Flow Rate on Day 7
Change from BaseLine in mean evening post-dose daily peak flow rate on Day 7
Measured: Day 7

Timeline

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

Mar 2010Nov 2010

First posted11 Mar 2010 (estimated)
Study startMar 2010
Primary completionNov 2010
Study completionNov 2010

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 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 118 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01085045
Sponsor's protocol ID: PT0031002
Status last verified: Mar 2017
First submitted: 9 Mar 2010
Last updated: 26 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Reisner C, Fabbri LM, Kerwin EM, Fogarty C, Spangenthal S, Rabe KF, Ferguson GT, Martinez FJ, Donohue JF, Darken P, St Rose E, Orevillo C, Strom S, Fischer T, Golden M, Dwivedi S. A randomized, seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease. Respir Res. 2017 Jan 6;18(1):8. doi: 10.1186/s12931-016-0491-8.
PubMed 28061907

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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All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (7 Days), Four-Period, Eight-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Two Doses of PT003, Two Doses of PT005 and One Dose of PT001 in Patients With Moderate to Very Severe COPD, Compared With Foradil® Aerolizer® (12 μg, Open-Label) and Spiriva® Handihaler® (18 μg, Open-Label) as Active Controls
ClinicalTrials.gov ID: NCT01085045
Acronym / sponsor ID: PT0031002
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 118 participants (actual)
Lead sponsor: Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 11 Mar 2010 (estimated)
Results: Posted 26 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: 8

Arm	Type	Receives
Inhaled PT003 (Dose 1)	Experimental	Drug: PT003 MDIPT003 MDI Dose 1
Inhaled PT003 (Dose 2)	Experimental	Drug: PT003 MDIPT003 MDI Dose 2
Inhaled PT005 (Dose 1)	Experimental	Drug: PT005 MDIPT005 MDI Dose 1
Inhaled PT005 (Dose 2)	Experimental	Drug: PT005 MDIPT005 MDI Dose 2
Inhaled Placebo	Placebo comparator	Drug: Placebo MDIPlacebo MDI
Tiotropium bromide 18 μg (Spiriva Handihaler®)	Active comparator	Drug: Tiotropium bromide 18 μg (Spiriva Handihaler®)Tiotropium Bromide inhalation powder
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)	Active comparator	Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)Formoterol fumarate inhalation powder 12 μg
Inhaled PT001 (Dose 1)	Experimental	Drug: PT001 MDIPT001 MDI Dose 1

Who may qualify

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

Key inclusion criteria (8 listed)

Signed written informed consent
40 - 80 years of age
Clinical history of COPD with airflow limitation that is not fully reversible
Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
Current/former smokers with at least a 10 pack-year history of cigarette smoking

Key exclusion criteria (11 listed)

Women who are pregnant or lactating
Primary diagnosis of asthma
Alpha-1 antitrypsin deficiency as the cause of COPD
Active pulmonary diseases
Prior lung volume reduction surgery

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
PT003 MDIInhaled PT003 MDI administered as two puffs BID for 7 days	Drug	Inhaled PT003 (Dose 1), Inhaled PT003 (Dose 2)
PT005 MDIInhaled PT005 MDI administered as two puffs BID for 7 days	Drug	Inhaled PT005 (Dose 1), Inhaled PT005 (Dose 2)
Placebo MDIInhaled placebo administered as two puffs BID for 7 days	Drug	Inhaled Placebo
Tiotropium bromide 18 μg (Spiriva Handihaler®)Inhaled tiotropium bromide 18 μg (Spiriva Handihaler®) administered QD for 7 days	Drug	Tiotropium bromide 18 μg (Spiriva Handihaler®)
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)Inhaled formoterol fumarate 12 μg (Foradil® Aerolizer®) administered BID for 7 days	Drug	Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
PT001 MDIInhaled PT001 MDI administered as two puffs BID for 7 days	Drug	Inhaled PT001 (Dose 1)

Primary outcome

FEV1 AUC 0-12 on Day 7
Time frame: "Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 11.5, and 12 hours post-dose on Day 7
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 (normalized) relative to baseline FEV1 following 7-day dose administration

12 secondary outcomes

Peak Change From BL in FEV1 on Day 1
Time frame: Day 1
Peak Change From BL in FEV1 on Day 7
Time frame: Day 7
Peak Change From BL in Inspiratory Capacity on Day 1
Time frame: Day 1
Peak Change From BL IC on Day 7
Time frame: Day 7
Time to Onset of Action >=10% Improvement in FEV1 on Day 1
Time frame: Day 1
Percentage of Patients Achieving >=12% Improvement in FEV1 on Day 1
Time frame: Day 1
Change in Morning Pre-dose FEV1 on Day 7
Time frame: Day 7
12 hr Post-dose Trough FEV1 on Day 7
Time frame: Day 7
Change From BL in Mean Morning Pre-dose Daily Peak Flow Rate on Day 7
Time frame: Day 7
Change From BL in Mean Morning Post-dose Daily Peak Flow Rate on Day 7
Time frame: Day 7
Change From BL in Mean Evening Pre-dose Daily Peak Flow Rate on Day 7
Time frame: Day 7
Change From BL in Mean Evening Post-dose Daily Peak Flow Rate on Day 7
Time frame: Day 7

Results and safety

Results posted to the registry on 26 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	122	104

Primary outcome: FEV1 AUC 0-12 on Day 7

Time frame: "Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 11.5, and 12 hours post-dose on Day 7. Least squares mean (95% Confidence Interval). Unit: Liters

Measure	GFF MDI 72/9.6 μg n = 37	GFF MDI 36/9.6 μg n = 38	GP MDI 36 μg n = 35	Spiriva 18 μg n = 53	FF MDI 9.6 μg n = 55	FF MDI 7.2 μg n = 58	Foradil 12 μg n = 53
Value	1.537 (1.499 to 1.575)	1.529 (1.492 to 1.567)	1.429 (1.389 to 1.469)	1.434 (1.401 to 1.467)	1.421 (1.386 to 1.455)	1.413 (1.379 to 1.446)	1.437 (1.401 to 1.472)

Population analysed: Modified Intent to Treat (MITT) Population - not including the 4 sentinel patients.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GP/FF MDI 72/9.6 μg	0 of 41 (0%)	14 of 41 (34.1%)	Not reported
GP/FF MDI 36/9.6 μg	1 of 43 (2.3%)	17 of 43 (39.5%)	Not reported
GP MDI 36 μg	0 of 41 (0%)	10 of 41 (24.4%)	Not reported
Spiriva	2 of 58 (3.4%)	9 of 58 (15.5%)	Not reported
FF MDI 9.6 μg	1 of 64 (1.6%)	5 of 64 (7.8%)	Not reported
FF MDI 7.2 μg	2 of 64 (3.1%)	4 of 64 (6.3%)	Not reported
Placebo	0 of 52 (0%)	4 of 52 (7.7%)	Not reported
Foradil Aerolizer	0 of 55 (0%)	7 of 55 (12.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28061907Reisner C, Fabbri LM, Kerwin EM, Fogarty C, Spangenthal S, Rabe KF, Ferguson GT, Martinez FJ, Donohue JF, Darken P, St Rose E, Orevillo C, Strom S, Fischer T, Golden M, Dwivedi S. A randomized, seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease. Respir Res. 2017 Jan 6;18(1):8. doi: 10.1186/s12931-016-0491-8.

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Active, not recruiting
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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, M.D. study director

Pearl Therapeutics, Inc.

16 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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

Where is the study taking place?

The record lists 16 sites in Australia, United States, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 26 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?

FEV1 AUC 0-12 on Day 7 (time frame: "Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 11.5, and 12 hours post-dose on Day 7). 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 NCT01085045, 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 26 Apr 2017.