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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01970878




Registration number
NCT01970878
Ethics application status
Date submitted
18/10/2013
Date registered
28/10/2013
Date last updated
17/03/2017

Titles & IDs
Public title
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)
Scientific 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
Secondary ID [1] 0 0
PT003008-00
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GFF MDI (PT 003)
Treatment: Drugs - GP MDI (PT001)
Treatment: Drugs - FF MDI (PT005)
Treatment: Drugs - Open-label tiotropium bromide inhalation (Spiriva® Handihaler®)

Experimental: GFF MDI (PT003) -

Experimental: GP MDI (PT001) -

Experimental: FF MDI (PT005) -

Active Comparator: Open-label tiotropium bromide inhalation powder - Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)


Treatment: Drugs: GFF MDI (PT 003)
GFF MDI administered as two puffs BID

Treatment: Drugs: GP MDI (PT001)
GP MDI administered as two puffs BID

Treatment: Drugs: FF MDI (PT005)
FF MDI administered as two puffs BID

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

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks
Timepoint [1] 0 0
Baseline and Weeks 2 to 52
Secondary outcome [1] 0 0
Self-Administered Computerized (SAC) TDI Focal Score Over 52 Weeks
Timepoint [1] 0 0
Baseline and Weeks 4 to 52
Secondary outcome [2] 0 0
Peak Change From Baseline in FEV1 Within 2 Hrs Post-dosing
Timepoint [2] 0 0
Baseline and Weeks 2 to 52
Secondary outcome [3] 0 0
Change From Baseline in SGRQ Total Score
Timepoint [3] 0 0
Baseline and Weeks 12 to 52
Secondary outcome [4] 0 0
Change From Baseline in Average Daily Rescue Ventolin Use
Timepoint [4] 0 0
Baseline through Week 52

Eligibility
Key inclusion criteria
Key

- 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

Key
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

- 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 ß2-agonists, glycopyrronium or other muscarinic
anticholinergics, lactose/milk protein or any component of the MDI

Other protocol-defined inclusion/exclusion criteria may apply

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2015
Sample size
Target
Accrual to date
Final
892
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Pearl Investigative Site - New Lambton
Recruitment hospital [2] 0 0
Pearl Investigative Site - Westmead
Recruitment hospital [3] 0 0
Pearl Investigative Site - Brisbane
Recruitment hospital [4] 0 0
Pearl Investigative Site - Cairns
Recruitment hospital [5] 0 0
Pearl Investigative Site - Wooloongabba
Recruitment hospital [6] 0 0
Pearl Investigative Site - Adelaide
Recruitment hospital [7] 0 0
Pearl Investigative Site - Heidelberg
Recruitment hospital [8] 0 0
Pearl Investigative Site - Nederlands
Recruitment hospital [9] 0 0
Pearl Investigative Site - Perth
Recruitment postcode(s) [1] 0 0
- New Lambton
Recruitment postcode(s) [2] 0 0
- Westmead
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 0 0
- Cairns
Recruitment postcode(s) [5] 0 0
- Wooloongabba
Recruitment postcode(s) [6] 0 0
- Adelaide
Recruitment postcode(s) [7] 0 0
- Heidelberg
Recruitment postcode(s) [8] 0 0
- Nederlands
Recruitment postcode(s) [9] 0 0
- Perth
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Idaho
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maryland
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Michigan
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Minnesota
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Missouri
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Nebraska
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Nevada
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New Mexico
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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Vermont
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West Virginia
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Wisconsin
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New Zealand
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Aukland
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Dunedin
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New Zealand
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East Aukland
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Waikato
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Wellington
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New Zealand
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Tauranga

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 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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01970878
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Colin Reisner, MD
Address 0 0
Pearl Therapeutics, Inc.
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