Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01854645
Registration number
NCT01854645
Ethics application status
Date submitted
13/05/2013
Date registered
15/05/2013
Date last updated
28/03/2017
Titles & IDs
Public title
Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)
Query!
Scientific title
A Randomized, Double Blind, Chronic Dosing, Placebo-Controlled, Parallel Group, Multi Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo and Spiriva® Handihaler® (Tiotropium Bromide 18 µg Open-Label) as an Active Control
Query!
Secondary ID [1]
0
0
PT003006-00
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Chronic obstructive pulmonary disease
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - GFF MDI
Treatment: Drugs - GP MDI
Treatment: Drugs - FF MDI
Treatment: Drugs - Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)
Treatment: Drugs - Placebo MDI
Experimental: GFF MDI - Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) (PT003)
Experimental: GP MDI - Glycopyrronium (GP) MDI (PT001)
Experimental: FF MDI - Formoterol Fumarate (FF) MDI (PT005)
Active comparator: Open-label tiotropium bromide inhalation powder - Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)
Placebo comparator: Placebo - Placebo MDI
Treatment: Drugs: GFF MDI
GFF MDI administered as two puffs Bis in Di.e. Twice Daily (BID)
Treatment: Drugs: GP MDI
GP MDI administered as two puffs BID
Treatment: Drugs: FF MDI
FF MDI administered as two puffs BID
Treatment: Drugs: Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)
Taken as 1 capsule daily containing 18 µg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)
Treatment: Drugs: Placebo MDI
Inhaled placebo administered as two puffs BID
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24
Query!
Assessment method [1]
0
0
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24
Query!
Timepoint [1]
0
0
Baseline and at Week 24
Query!
Secondary outcome [1]
0
0
Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks
Query!
Assessment method [1]
0
0
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) over 24 weeks. FEV1 was assessed at multiple time points post-baseline,and a modelbased average of all visits starting from Week 2 through week 24 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.
Query!
Timepoint [1]
0
0
Baseline and Weeks 2 to 24
Query!
Secondary outcome [2]
0
0
St. George's Respiratory Questionnaire (SGRQ) Score
Query!
Assessment method [2]
0
0
Change from baseline in the SGRQ total score. 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 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.
Query!
Timepoint [2]
0
0
Baseline and at Week 24
Query!
Secondary outcome [3]
0
0
Rescue Ventolin Hydrofluoroalkane (HFA) Use
Query!
Assessment method [3]
0
0
Change from baseline in average daily rescue Ventolin HFA use
Query!
Timepoint [3]
0
0
Baseline and at Week 24
Query!
Secondary outcome [4]
0
0
Onset of Action as Assessed by FEV1
Query!
Assessment method [4]
0
0
Defined as the first time-point using the 5- and 15-minute post dose measurements where the difference in FEV1 from Placebo was statistically significant
Query!
Timepoint [4]
0
0
Assessed for 5- and 15-minute post dose on Day 1
Query!
Secondary outcome [5]
0
0
Peak Change From Baseline in FEV1 Within 2 Hours Post-dose
Query!
Assessment method [5]
0
0
Peak change from baseline in forced expiratory volume in 1 second (FEV1) within 2 hours post-dose
Query!
Timepoint [5]
0
0
Baseline and at Week 24
Query!
Eligibility
Key inclusion criteria
Key
* 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.
* Average f the -60 and the -30 min pre-dose FEV1 assessments must be < 80% predicted normal value calculated using National Health and Nutrition Examination Survey (NHANES) III reference equations.
* Subjects willing and, in the opinion of the investigator, able to adjust current COPD therapy as required by the protocol
Key
Query!
Minimum age
40
Years
Query!
Query!
Maximum age
80
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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 ECG
* Abnormal liver function tests defined as aspartate transaminase (AST), alanine transaminase (ALT), 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/05/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/02/2015
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
2103
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Pearl Investigative Site - New Lambton
Query!
Recruitment hospital [2]
0
0
Pearl Investigative Site - Westmead
Query!
Recruitment hospital [3]
0
0
Pearl Investigative Site - Brisbane
Query!
Recruitment hospital [4]
0
0
Pearl Investigative Site - Cairns
Query!
Recruitment hospital [5]
0
0
Pearl Investigative Site - Wooloongabba
Query!
Recruitment hospital [6]
0
0
Pearl Investigative Site - Adelaide
Query!
Recruitment hospital [7]
0
0
Pearl Investigative Site - Daw Park
Query!
Recruitment hospital [8]
0
0
Pearl Investigative Site - Toorak Gardens
Query!
Recruitment hospital [9]
0
0
Pearl Investigative Site - Box Hill
Query!
Recruitment hospital [10]
0
0
Pearl Investigative Site - Heidelberg
Query!
Recruitment hospital [11]
0
0
Pearl Investigative Site - Nedlands
Query!
Recruitment hospital [12]
0
0
Pearl Investigative Site - Perth
Query!
Recruitment postcode(s) [1]
0
0
- New Lambton
Query!
Recruitment postcode(s) [2]
0
0
- Westmead
Query!
Recruitment postcode(s) [3]
0
0
- Brisbane
Query!
Recruitment postcode(s) [4]
0
0
- Cairns
Query!
Recruitment postcode(s) [5]
0
0
- Wooloongabba
Query!
Recruitment postcode(s) [6]
0
0
- Adelaide
Query!
Recruitment postcode(s) [7]
0
0
- Daw Park
Query!
Recruitment postcode(s) [8]
0
0
- Toorak Gardens
Query!
Recruitment postcode(s) [9]
0
0
- Box Hill
Query!
Recruitment postcode(s) [10]
0
0
- Heidelberg
Query!
Recruitment postcode(s) [11]
0
0
- Nedlands
Query!
Recruitment postcode(s) [12]
0
0
- Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Idaho
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Indiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Iowa
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Kansas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Kentucky
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Louisiana
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Maryland
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Michigan
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Minnesota
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Missouri
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Montana
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Nebraska
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Nevada
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
New Jersey
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
New Mexico
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
New York
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
North Carolina
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Ohio
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Oregon
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Pennsylvania
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
South Carolina
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
South Dakota
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Tennessee
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Texas
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Utah
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Vermont
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
Virginia
Query!
Country [36]
0
0
United States of America
Query!
State/province [36]
0
0
Washington
Query!
Country [37]
0
0
United States of America
Query!
State/province [37]
0
0
West Virginia
Query!
Country [38]
0
0
United States of America
Query!
State/province [38]
0
0
Wisconsin
Query!
Country [39]
0
0
New Zealand
Query!
State/province [39]
0
0
Aukland
Query!
Country [40]
0
0
New Zealand
Query!
State/province [40]
0
0
Dunedin
Query!
Country [41]
0
0
New Zealand
Query!
State/province [41]
0
0
East Aukland
Query!
Country [42]
0
0
New Zealand
Query!
State/province [42]
0
0
Waikato
Query!
Country [43]
0
0
New Zealand
Query!
State/province [43]
0
0
Wellington
Query!
Country [44]
0
0
New Zealand
Query!
State/province [44]
0
0
Tauranga
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Pearl Therapeutics, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The overall objective of this study is to assess the efficacy and safety of treatment with PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to very severe COPD.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01854645
Query!
Trial related presentations / publications
Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314. Martinez FJ, Lipworth BJ, Rabe KF, Collier DJ, Ferguson GT, Sethi S, Feldman GJ, O'Brien G, Jenkins M, Reisner C. Benefits of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) in improving lung function and reducing exacerbations in patients with moderate-to-very severe COPD: a pooled analysis of the PINNACLE studies. Respir Res. 2020 May 25;21(1):128. doi: 10.1186/s12931-020-01388-y. Martinez FJ, Rabe KF, Lipworth BJ, Arora S, Jenkins M, Martin UJ, Reisner C. Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Improves Lung Function versus Monotherapies in GOLD Category A Patients with COPD: Pooled Data from the Phase III PINNACLE Studies. Int J Chron Obstruct Pulmon Dis. 2020 Jan 9;15:99-106. doi: 10.2147/COPD.S229794. eCollection 2020. Martinez FJ, Fabbri LM, Ferguson GT, Orevillo C, Darken P, Martin UJ, Reisner C. Baseline Symptom Score Impact on Benefits of Glycopyrrolate/Formoterol Metered Dose Inhaler in COPD. Chest. 2017 Dec;152(6):1169-1178. doi: 10.1016/j.chest.2017.07.007. Epub 2017 Jul 16.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Colin Reisner, MD
Query!
Address
0
0
Pearl Therapeutics, Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01854645
Download to PDF