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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02465567
Registration number
NCT02465567
Ethics application status
Date submitted
29/05/2015
Date registered
8/06/2015
Date last updated
2/02/2021
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)
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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)
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Secondary ID [1]
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PT010005
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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:
COPD
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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 (PT009)
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 (PT003)
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
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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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Adjusted Rate of Moderate or Severe Exacerbations
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Assessment method [1]
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Adjusted Rate of Moderate or Severe Exacerbations
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Timepoint [1]
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52-week treatment period
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Secondary outcome [1]
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Time to First Moderate or Severe COPD Exacerbation
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Assessment method [1]
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Time to first moderate or severe COPD exacerbation (proportion with event reported as median time was not reached, statistical analyses are based upon time to event)
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Timepoint [1]
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52 Weeks
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Secondary outcome [2]
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Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks
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Assessment method [2]
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Change from baseline in average daily rescue Ventolin HFA use over 24 weeks
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Timepoint [2]
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24 Weeks
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Secondary outcome [3]
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Percentage of Subjects Achieving a MCID of 4 Units or More in SGRQ Total Score
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Assessment method [3]
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Percentage of subjects achieving a minimal clinically important difference (MCID) of 4 units or more in SGRQ (St. George's Respiratory Questionnaire) total score at Week 24
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Timepoint [3]
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at Week 24
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Secondary outcome [4]
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Time to Death (All Cause)
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Assessment method [4]
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Subject Deaths (all cause)
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Timepoint [4]
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52 Weeks
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Secondary outcome [5]
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Rate of Severe COPD Exacerbations
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Assessment method [5]
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Rate of severe COPD exacerbations
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Timepoint [5]
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52 Weeks
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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.
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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
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.
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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 assessing the outcomes
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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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
30/06/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/07/2019
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Sample size
Target
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Final
8588
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Recruitment in Australia
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5000 - Adelaide
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5042 - Bedford Park
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3128 - Box Hill
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2139 - Concord
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4053 - Everton Park
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5067 - Kent Town
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6150 - Murdoch
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6009 - Nedlands
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4101 - South Brisbane
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2145 - Westmead
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0
0
China
Query!
State/province [112]
0
0
Nanjing
Query!
Country [113]
0
0
China
Query!
State/province [113]
0
0
Pingxiang
Query!
Country [114]
0
0
China
Query!
State/province [114]
0
0
Shanghai
Query!
Country [115]
0
0
China
Query!
State/province [115]
0
0
Shenyang
Query!
Country [116]
0
0
China
Query!
State/province [116]
0
0
Shenzhen
Query!
Country [117]
0
0
China
Query!
State/province [117]
0
0
Shijiazhuang
Query!
Country [118]
0
0
China
Query!
State/province [118]
0
0
Wuhan
Query!
Country [119]
0
0
China
Query!
State/province [119]
0
0
Xi'an
Query!
Country [120]
0
0
China
Query!
State/province [120]
0
0
Xiangtan
Query!
Country [121]
0
0
China
Query!
State/province [121]
0
0
Xuzhou
Query!
Country [122]
0
0
China
Query!
State/province [122]
0
0
Yanji
Query!
Country [123]
0
0
China
Query!
State/province [123]
0
0
Zhanjiang
Query!
Country [124]
0
0
Czechia
Query!
State/province [124]
0
0
Benešov
Query!
Country [125]
0
0
Czechia
Query!
State/province [125]
0
0
Beroun
Query!
Country [126]
0
0
Czechia
Query!
State/province [126]
0
0
Jindrichuv Hradec
Query!
Country [127]
0
0
Czechia
Query!
State/province [127]
0
0
Liberec 1
Query!
Country [128]
0
0
Czechia
Query!
State/province [128]
0
0
Liberec
Query!
Country [129]
0
0
Czechia
Query!
State/province [129]
0
0
Melnik
Query!
Country [130]
0
0
Czechia
Query!
State/province [130]
0
0
Moravsky Krumlov
Query!
Country [131]
0
0
Czechia
Query!
State/province [131]
0
0
Praha 10
Query!
Country [132]
0
0
Czechia
Query!
State/province [132]
0
0
Praha 1
Query!
Country [133]
0
0
Czechia
Query!
State/province [133]
0
0
Teplice
Query!
Country [134]
0
0
Czechia
Query!
State/province [134]
0
0
Zatec
Query!
Country [135]
0
0
France
Query!
State/province [135]
0
0
Lyon Cedex 4
Query!
Country [136]
0
0
France
Query!
State/province [136]
0
0
Marseille
Query!
Country [137]
0
0
France
Query!
State/province [137]
0
0
Nantes
Query!
Country [138]
0
0
France
Query!
State/province [138]
0
0
Nimes Cedex 09
Query!
Country [139]
0
0
France
Query!
State/province [139]
0
0
Vandoeuvre les Nancy
Query!
Country [140]
0
0
Germany
Query!
State/province [140]
0
0
Aschaffenburg
Query!
Country [141]
0
0
Germany
Query!
State/province [141]
0
0
Augsburg
Query!
Country [142]
0
0
Germany
Query!
State/province [142]
0
0
Bad Wörishofen
Query!
Country [143]
0
0
Germany
Query!
State/province [143]
0
0
Bamberg
Query!
Country [144]
0
0
Germany
Query!
State/province [144]
0
0
Bergisch Gladbach
Query!
Country [145]
0
0
Germany
Query!
State/province [145]
0
0
Berlin
Query!
Country [146]
0
0
Germany
Query!
State/province [146]
0
0
Bonn
Query!
Country [147]
0
0
Germany
Query!
State/province [147]
0
0
Cottbus
Query!
Country [148]
0
0
Germany
Query!
State/province [148]
0
0
Darmstadt
Query!
Country [149]
0
0
Germany
Query!
State/province [149]
0
0
Deggendorf
Query!
Country [150]
0
0
Germany
Query!
State/province [150]
0
0
Deggingen
Query!
Country [151]
0
0
Germany
Query!
State/province [151]
0
0
Dortmund
Query!
Country [152]
0
0
Germany
Query!
State/province [152]
0
0
Düren
Query!
Country [153]
0
0
Germany
Query!
State/province [153]
0
0
Erlangen
Query!
Country [154]
0
0
Germany
Query!
State/province [154]
0
0
Essen
Query!
Country [155]
0
0
Germany
Query!
State/province [155]
0
0
Frankfurt am Main
Query!
Country [156]
0
0
Germany
Query!
State/province [156]
0
0
Frankfurt
Query!
Country [157]
0
0
Germany
Query!
State/province [157]
0
0
Gelsenkirchen
Query!
Country [158]
0
0
Germany
Query!
State/province [158]
0
0
Grosshansdof
Query!
Country [159]
0
0
Germany
Query!
State/province [159]
0
0
Halle
Query!
Country [160]
0
0
Germany
Query!
State/province [160]
0
0
Hamburg
Query!
Country [161]
0
0
Germany
Query!
State/province [161]
0
0
Hannover
Query!
Country [162]
0
0
Germany
Query!
State/province [162]
0
0
Ibbenbüren
Query!
Country [163]
0
0
Germany
Query!
State/province [163]
0
0
Kiel
Query!
Country [164]
0
0
Germany
Query!
State/province [164]
0
0
Koblenz
Query!
Country [165]
0
0
Germany
Query!
State/province [165]
0
0
Köln
Query!
Country [166]
0
0
Germany
Query!
State/province [166]
0
0
Landsberg
Query!
Country [167]
0
0
Germany
Query!
State/province [167]
0
0
Leipzig
Query!
Country [168]
0
0
Germany
Query!
State/province [168]
0
0
Lübeck
Query!
Country [169]
0
0
Germany
Query!
State/province [169]
0
0
Magdeburg
Query!
Country [170]
0
0
Germany
Query!
State/province [170]
0
0
Mainz
Query!
Country [171]
0
0
Germany
Query!
State/province [171]
0
0
Marburg
Query!
Country [172]
0
0
Germany
Query!
State/province [172]
0
0
München
Query!
Country [173]
0
0
Germany
Query!
State/province [173]
0
0
Münster
Query!
Country [174]
0
0
Germany
Query!
State/province [174]
0
0
Neu-Isenburg
Query!
Country [175]
0
0
Germany
Query!
State/province [175]
0
0
Peine
Query!
Country [176]
0
0
Germany
Query!
State/province [176]
0
0
Potsdam
Query!
Country [177]
0
0
Germany
Query!
State/province [177]
0
0
Radebeul
Query!
Country [178]
0
0
Germany
Query!
State/province [178]
0
0
Rosenheim
Query!
Country [179]
0
0
Germany
Query!
State/province [179]
0
0
Ruesselsheim
Query!
Country [180]
0
0
Germany
Query!
State/province [180]
0
0
Rüdersdorf
Query!
Country [181]
0
0
Germany
Query!
State/province [181]
0
0
Schleswig
Query!
Country [182]
0
0
Germany
Query!
State/province [182]
0
0
Schwedt
Query!
Country [183]
0
0
Germany
Query!
State/province [183]
0
0
Wardenburg
Query!
Country [184]
0
0
Germany
Query!
State/province [184]
0
0
Weinheim
Query!
Country [185]
0
0
Germany
Query!
State/province [185]
0
0
Wiesbaden
Query!
Country [186]
0
0
Germany
Query!
State/province [186]
0
0
Wiesloch
Query!
Country [187]
0
0
Germany
Query!
State/province [187]
0
0
Witten
Query!
Country [188]
0
0
Germany
Query!
State/province [188]
0
0
Zerbst
Query!
Country [189]
0
0
Hungary
Query!
State/province [189]
0
0
Balassagyarmat
Query!
Country [190]
0
0
Hungary
Query!
State/province [190]
0
0
Budapest
Query!
Country [191]
0
0
Hungary
Query!
State/province [191]
0
0
Csorna
Query!
Country [192]
0
0
Hungary
Query!
State/province [192]
0
0
Debrecen
Query!
Country [193]
0
0
Hungary
Query!
State/province [193]
0
0
Gödöllo
Query!
Country [194]
0
0
Hungary
Query!
State/province [194]
0
0
Kaposvár
Query!
Country [195]
0
0
Hungary
Query!
State/province [195]
0
0
Kapuvar
Query!
Country [196]
0
0
Hungary
Query!
State/province [196]
0
0
Komarom
Query!
Country [197]
0
0
Hungary
Query!
State/province [197]
0
0
Komló
Query!
Country [198]
0
0
Hungary
Query!
State/province [198]
0
0
Miskolc
Query!
Country [199]
0
0
Hungary
Query!
State/province [199]
0
0
Nyíregyháza
Query!
Country [200]
0
0
Hungary
Query!
State/province [200]
0
0
Siófok
Query!
Country [201]
0
0
Hungary
Query!
State/province [201]
0
0
Szigetszentmiklós
Query!
Country [202]
0
0
Hungary
Query!
State/province [202]
0
0
Százhalombatta
Query!
Country [203]
0
0
Hungary
Query!
State/province [203]
0
0
Törökbálint
Query!
Country [204]
0
0
Italy
Query!
State/province [204]
0
0
Bologna
Query!
Country [205]
0
0
Italy
Query!
State/province [205]
0
0
Foggia
Query!
Country [206]
0
0
Italy
Query!
State/province [206]
0
0
Genova
Query!
Country [207]
0
0
Italy
Query!
State/province [207]
0
0
Messina
Query!
Country [208]
0
0
Italy
Query!
State/province [208]
0
0
Milan
Query!
Country [209]
0
0
Italy
Query!
State/province [209]
0
0
Modena
Query!
Country [210]
0
0
Italy
Query!
State/province [210]
0
0
Napoli
Query!
Country [211]
0
0
Italy
Query!
State/province [211]
0
0
Palermo
Query!
Country [212]
0
0
Italy
Query!
State/province [212]
0
0
Parma
Query!
Country [213]
0
0
Italy
Query!
State/province [213]
0
0
Pisa
Query!
Country [214]
0
0
Italy
Query!
State/province [214]
0
0
Pordenone
Query!
Country [215]
0
0
Italy
Query!
State/province [215]
0
0
Roma
Query!
Country [216]
0
0
Italy
Query!
State/province [216]
0
0
Tradate
Query!
Country [217]
0
0
Japan
Query!
State/province [217]
0
0
Osakasayama-shi
Query!
Country [218]
0
0
Japan
Query!
State/province [218]
0
0
Sakaide-shi
Query!
Country [219]
0
0
Japan
Query!
State/province [219]
0
0
Seto-shi
Query!
Country [220]
0
0
Japan
Query!
State/province [220]
0
0
Shinagawa-ku
Query!
Country [221]
0
0
Japan
Query!
State/province [221]
0
0
Yanagawa-shi
Query!
Country [222]
0
0
Mexico
Query!
State/province [222]
0
0
Cuautitlan Izcalli
Query!
Country [223]
0
0
Mexico
Query!
State/province [223]
0
0
Guadalajara
Query!
Country [224]
0
0
Mexico
Query!
State/province [224]
0
0
Mexico
Query!
Country [225]
0
0
Mexico
Query!
State/province [225]
0
0
Monterrey
Query!
Country [226]
0
0
Netherlands
Query!
State/province [226]
0
0
Almelo
Query!
Country [227]
0
0
Netherlands
Query!
State/province [227]
0
0
Almere
Query!
Country [228]
0
0
Netherlands
Query!
State/province [228]
0
0
Beek
Query!
Country [229]
0
0
Netherlands
Query!
State/province [229]
0
0
Breda
Query!
Country [230]
0
0
Netherlands
Query!
State/province [230]
0
0
Capelle aan den IJssel
Query!
Country [231]
0
0
Netherlands
Query!
State/province [231]
0
0
Eindhoven
Query!
Country [232]
0
0
Netherlands
Query!
State/province [232]
0
0
Enschede
Query!
Country [233]
0
0
Netherlands
Query!
State/province [233]
0
0
Harderwijk
Query!
Country [234]
0
0
Netherlands
Query!
State/province [234]
0
0
Heerlen
Query!
Country [235]
0
0
Netherlands
Query!
State/province [235]
0
0
Hoorn NH
Query!
Country [236]
0
0
Netherlands
Query!
State/province [236]
0
0
Voerendaal
Query!
Country [237]
0
0
Netherlands
Query!
State/province [237]
0
0
Zutphen
Query!
Country [238]
0
0
Netherlands
Query!
State/province [238]
0
0
Zwolle
Query!
Country [239]
0
0
New Zealand
Query!
State/province [239]
0
0
Auckland
Query!
Country [240]
0
0
New Zealand
Query!
State/province [240]
0
0
Christchurch
Query!
Country [241]
0
0
New Zealand
Query!
State/province [241]
0
0
Dunedin
Query!
Country [242]
0
0
New Zealand
Query!
State/province [242]
0
0
Greenlane East
Query!
Country [243]
0
0
New Zealand
Query!
State/province [243]
0
0
Greenlane
Query!
Country [244]
0
0
New Zealand
Query!
State/province [244]
0
0
Hamilton
Query!
Country [245]
0
0
New Zealand
Query!
State/province [245]
0
0
Havelock North
Query!
Country [246]
0
0
New Zealand
Query!
State/province [246]
0
0
Newtown
Query!
Country [247]
0
0
New Zealand
Query!
State/province [247]
0
0
Papatoetoe
Query!
Country [248]
0
0
New Zealand
Query!
State/province [248]
0
0
Tauranga
Query!
Country [249]
0
0
Peru
Query!
State/province [249]
0
0
Cusco
Query!
Country [250]
0
0
Peru
Query!
State/province [250]
0
0
Lima
Query!
Country [251]
0
0
Peru
Query!
State/province [251]
0
0
Miraflores
Query!
Country [252]
0
0
Peru
Query!
State/province [252]
0
0
Piura
Query!
Country [253]
0
0
Peru
Query!
State/province [253]
0
0
Santa Beatriz
Query!
Country [254]
0
0
Poland
Query!
State/province [254]
0
0
Bialystok
Query!
Country [255]
0
0
Poland
Query!
State/province [255]
0
0
Bydgoszcz
Query!
Country [256]
0
0
Poland
Query!
State/province [256]
0
0
Poznan
Query!
Country [257]
0
0
Poland
Query!
State/province [257]
0
0
Ruda Slaska
Query!
Country [258]
0
0
Poland
Query!
State/province [258]
0
0
Rzeszow
Query!
Country [259]
0
0
Poland
Query!
State/province [259]
0
0
Rzeszów
Query!
Country [260]
0
0
Poland
Query!
State/province [260]
0
0
Skarzysko-Kamienna
Query!
Country [261]
0
0
Poland
Query!
State/province [261]
0
0
Szczecin
Query!
Country [262]
0
0
Poland
Query!
State/province [262]
0
0
Tarnów
Query!
Country [263]
0
0
Poland
Query!
State/province [263]
0
0
Warszawa
Query!
Country [264]
0
0
Poland
Query!
State/province [264]
0
0
Wroclaw
Query!
Country [265]
0
0
Poland
Query!
State/province [265]
0
0
Zabrze
Query!
Country [266]
0
0
Russian Federation
Query!
State/province [266]
0
0
Arkhangelsk
Query!
Country [267]
0
0
Russian Federation
Query!
State/province [267]
0
0
Ekaterinburg
Query!
Country [268]
0
0
Russian Federation
Query!
State/province [268]
0
0
Gatchina
Query!
Country [269]
0
0
Russian Federation
Query!
State/province [269]
0
0
Moscow
Query!
Country [270]
0
0
Russian Federation
Query!
State/province [270]
0
0
Saint Petersburg
Query!
Country [271]
0
0
Russian Federation
Query!
State/province [271]
0
0
St. Petersburg
Query!
Country [272]
0
0
Serbia
Query!
State/province [272]
0
0
Belgrade
Query!
Country [273]
0
0
Serbia
Query!
State/province [273]
0
0
Kragujevac
Query!
Country [274]
0
0
Serbia
Query!
State/province [274]
0
0
Nis
Query!
Country [275]
0
0
Serbia
Query!
State/province [275]
0
0
Sremska Kamenica
Query!
Country [276]
0
0
Serbia
Query!
State/province [276]
0
0
Valjevo
Query!
Country [277]
0
0
South Africa
Query!
State/province [277]
0
0
Benoni
Query!
Country [278]
0
0
South Africa
Query!
State/province [278]
0
0
Bloemfontein
Query!
Country [279]
0
0
South Africa
Query!
State/province [279]
0
0
Boksburg
Query!
Country [280]
0
0
South Africa
Query!
State/province [280]
0
0
Cape Town
Query!
Country [281]
0
0
South Africa
Query!
State/province [281]
0
0
Durban
Query!
Country [282]
0
0
South Africa
Query!
State/province [282]
0
0
Johannesburg
Query!
Country [283]
0
0
South Africa
Query!
State/province [283]
0
0
Port Elizabeth
Query!
Country [284]
0
0
South Africa
Query!
State/province [284]
0
0
Pretoria
Query!
Country [285]
0
0
South Africa
Query!
State/province [285]
0
0
Umhlanga
Query!
Country [286]
0
0
Spain
Query!
State/province [286]
0
0
Alcobendas
Query!
Country [287]
0
0
Spain
Query!
State/province [287]
0
0
Alicante
Query!
Country [288]
0
0
Spain
Query!
State/province [288]
0
0
Alzira
Query!
Country [289]
0
0
Spain
Query!
State/province [289]
0
0
Badalona(Barcelona)
Query!
Country [290]
0
0
Spain
Query!
State/province [290]
0
0
Barcelona
Query!
Country [291]
0
0
Spain
Query!
State/province [291]
0
0
Cartagena
Query!
Country [292]
0
0
Spain
Query!
State/province [292]
0
0
Coruna
Query!
Country [293]
0
0
Spain
Query!
State/province [293]
0
0
Girona
Query!
Country [294]
0
0
Spain
Query!
State/province [294]
0
0
Laredo
Query!
Country [295]
0
0
Spain
Query!
State/province [295]
0
0
Lleida
Query!
Country [296]
0
0
Spain
Query!
State/province [296]
0
0
Madrid
Query!
Country [297]
0
0
Spain
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Wokingham
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Funding & Sponsors
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Commercial sector/industry
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Name
Pearl Therapeutics, Inc.
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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.
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Trial website
https://clinicaltrials.gov/study/NCT02465567
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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. Rhodes K, Jenkins M, de Nigris E, Aurivillius M, Ouwens M. Relationship between risk, cumulative burden of exacerbations and mortality in patients with COPD: modelling analysis using data from the ETHOS study. BMC Med Res Methodol. 2022 May 25;22(1):150. doi: 10.1186/s12874-022-01616-7. Rabe KF, Martinez FJ, Ferguson GT, Wang C, Singh D, Wedzicha JA, Trivedi R, St Rose E, Ballal S, McLaren J, Darken P, Aurivillius M, Reisner C, Dorinsky P; ETHOS Investigators. Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD. N Engl J Med. 2020 Jul 2;383(1):35-48. doi: 10.1056/NEJMoa1916046. Epub 2020 Jun 24. Rabe KF, Martinez FJ, Ferguson GT, Wang C, Singh D, Wedzicha JA, Trivedi R, St Rose E, Ballal S, McLaren J, Darken P, Reisner C, Dorinsky P. A phase III study of triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler 320/18/9.6 mug and 160/18/9.6 mug using co-suspension delivery technology in moderate-to-very severe COPD: The ETHOS study protocol. Respir Med. 2019 Oct-Nov;158:59-66. doi: 10.1016/j.rmed.2019.08.010. Epub 2019 Aug 22.
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Public notes
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Contacts
Principal investigator
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Paul M Dorinsky, MD
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Pearl Therapeutics
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Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/67/NCT02465567/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/67/NCT02465567/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02465567
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