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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)
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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
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Secondary ID [1]
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PT003008-00
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD)
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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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)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks
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Assessment method [1]
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Change From Baseline in Morning Pre-Dose Trough FEV1 Over 52 Weeks as a Model-Based Average (ITT Population). FEV1 was assessed at multiple time points post-baseline, and a model-based average of all visits starting from Week 2 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.
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Timepoint [1]
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Baseline and Weeks 2 to 52
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Secondary outcome [1]
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Self-Administered Computerized (SAC) TDI Focal Score Over 52 Weeks
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Assessment method [1]
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SAC TDI focal score over 52 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9.
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Timepoint [1]
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Baseline and Weeks 4 to 52
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Secondary outcome [2]
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Peak Change From Baseline in FEV1 Within 2 Hrs Post-dosing
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Assessment method [2]
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Peak change from Baseline FEV1 Over 52 Weeks is a Model-Based Average (ITT Population). Peak FEV1 was assessed at multiple visits post-baseline, and a model-based average of all visits starting from Week 2 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average Peak FEV1 post-baseline.
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Timepoint [2]
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Baseline and Weeks 2 to 52
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Secondary outcome [3]
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Change From Baseline in SGRQ Total Score
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Assessment method [3]
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The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (best possible health status) to 100 (worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life. SGRQ Total Score was assessed at multiple visits post-baseline, and a model-based average of all visits starting from Week 12 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average SGRQ Total Score post-baseline.
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Timepoint [3]
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Baseline and Weeks 12 to 52
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Secondary outcome [4]
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Change From Baseline in Average Daily Rescue Ventolin Use
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Assessment method [4]
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Subjects recorded in their diary the number of puffs of rescue Ventolin HFA taken on each study day. The subject's average daily number of puffs of rescue Ventolin HFA was calculated over the entire 52-week treatment period. Missing values were ignored in both the numerator and denominator. Diary data recorded during the last 7 days of the 10-14 day screening period were used to calculate the baseline average. Change in rescue Ventolin HFA use was calculated by subtracting the baseline average from the 52-week average.
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Timepoint [4]
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Baseline through Week 52
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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
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Minimum age
40
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
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Actual
1/03/2015
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Sample size
Target
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Accrual to date
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Final
892
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Pearl Investigative Site - New Lambton
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Pearl Investigative Site - Westmead
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Pearl Investigative Site - Brisbane
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Pearl Investigative Site - Cairns
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Pearl Investigative Site - Wooloongabba
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Pearl Investigative Site - Adelaide
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Pearl Investigative Site - Heidelberg
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Recruitment hospital [8]
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Pearl Investigative Site - Nederlands
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Recruitment hospital [9]
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Pearl Investigative Site - Perth
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Recruitment postcode(s) [1]
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- New Lambton
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- Westmead
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- Brisbane
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- Wooloongabba
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- Adelaide
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- Heidelberg
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- Nederlands
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Recruitment postcode(s) [9]
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- Perth
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Recruitment outside Australia
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Alabama
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pearl Therapeutics, Inc.
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Ethics approval
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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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01970878
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Colin Reisner, MD
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Address
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Pearl Therapeutics, Inc.
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01970878
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