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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02465567




Registration number
NCT02465567
Ethics application status
Date submitted
29/05/2015
Date registered
8/06/2015
Date last updated
15/08/2018

Titles & IDs
Public title
Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)
Scientific title
A Randomized, Double-Blind, Multi-Center, Parallel-Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD (Ethos)
Secondary ID [1] 0 0
PT010005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGF MDI 320/14.4/9.6 µg
Treatment: Drugs - GFF MDI 14.4/9.6 µg
Treatment: Drugs - BGF MDI 160/14.4/9.6 µg
Treatment: Drugs - BFF MDI 320/9.6 µg

Experimental: BGF (PT010) MDI 320/14.4/9.6 µg - BGF MDI 320/14.4/9.6 µg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler [MDI])

Experimental: BGF (PT010) MDI 160/14.4/9.6 µg - BGF MDI 160/14.4/9.6 µg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler [MDI])

Experimental: BFF (PT009) MDI 320/9.6 µg - BFF MDI 320/9.6 µg Budesonide, Formoterol Fumarate Aerosol Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)

Experimental: GFF (PT003) MDI 14.4/9.6 µg - GFF MDI 14.4/9.6 µg Glycopyrronium, Formoterol Fumarate Aerosol Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)


Treatment: Drugs: BGF MDI 320/14.4/9.6 µg
Budensonide, Glycopyrronium, and Formoterol Fumarate

Treatment: Drugs: GFF MDI 14.4/9.6 µg
Glycopyrronium, and Formoterol Fumarate

Treatment: Drugs: BGF MDI 160/14.4/9.6 µg
Budensonide, Glycopyrronium, and Formoterol Fumarate

Treatment: Drugs: BFF MDI 320/9.6 µg
Budensonide, and Formoterol Fumarate

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of moderate or severe exacerbations - Rate of moderate or severe exacerbations
Timepoint [1] 0 0
(52-week treatment period)
Secondary outcome [1] 0 0
Time to first moderate or severe COPD exacerbation - Time to first moderate or severe COPD exacerbation
Timepoint [1] 0 0
52 Weeks
Secondary outcome [2] 0 0
Change from baseline in average daily rescue Ventolin HFA use over 24 weeks - Change from baseline in average daily rescue Ventolin HFA use over 24 weeks
Timepoint [2] 0 0
24 Weeks
Secondary outcome [3] 0 0
Percentage of subjects achieving a minimal clinically important difference - Percentage of subjects achieving a minimal clinically important difference of 4 units or more in SGRQ total score at Week 24
Timepoint [3] 0 0
24 Weeks
Secondary outcome [4] 0 0
Time to death (all cause) - Time to death (all cause)
Timepoint [4] 0 0
52 Weeks

Eligibility
Key inclusion criteria
Inclusion Criteria

- Non-child bearing potential (ie, physiologically incapable of becoming pregnant,
including any female who is 2 years post-menopausal); or Child bearing potential, has
a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive
methods used consistently and correctly for the duration of the study.

- 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.

- Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be
<0.70 and FEV1 must be <65% predicted normal value calculated using NHANES III
reference equations (or reference norms applicable to other regions).

- Subjects with history of exacerbations.

Please refer to the study protocol for the complete inclusion criteria list.
Minimum age
40 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Significant diseases or conditions other than COPD, 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, or are planning to become pregnant during the
course of the study, or women of childbearing potential who are not using an
acceptable method of contraception.

- 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 Visit 1 (Screening)

- 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
Visit 1 (Screening)

- Immune suppression or severe neurological disorders affecting control of the upper
airway or other risk factors that in the opinion of the Investigator would put the
subject at substantial risk of pneumonia.

- Subjects with a diagnosis of narrow angle glaucoma, who, in the opinion of the
Investigator, have not been adequately treated.

- Subjects who have a history of hypersensitivity to ß2-agonists, budesonide or any
other corticosteroid components, glycopyrronium or other muscarinic anticholinergics,
or any other component of the IMPs.

Please refer to the study protocol for the complete inclusion criteria list.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
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5000 - Adelaide
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3128 - Box Hill
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4870 - Cairns
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2139 - Concord
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5041 - Daw Park
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5067 - Kent Town
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4101 - South Brisbane
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2145 - Westmead
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Wokingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pearl Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy
and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate
to very severe COPD.
Trial website
https://clinicaltrials.gov/show/NCT02465567
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul M Dorinsky, MD
Address 0 0
Pearl Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications