A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)

September 3, 2019 updated by: Pearl Therapeutics, Inc.

A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD

This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be randomized to one of the following three treatment groups: PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 52 weeks.

Study Type

Interventional

Enrollment (Actual)

1876

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1414AIF
        • Research Site
      • Caba, Argentina
        • Research Site
      • Caba, Argentina, C1425BEN
        • Research Site
      • Caba, Argentina, C1056ABJ
        • Research Site
      • Caba, Argentina, 1426
        • Research Site
      • Ciudad Autonomade Buenos Aires, Argentina, 1426
        • Research Site
      • Ciudad Autónoma de Buenos Aire, Argentina, C1440BRR
        • Research Site
      • Ciudad de Buenos Aires, Argentina, 1425
        • Research Site
      • Concepción del Uruguay, Argentina, 3260
        • Research Site
      • Córdoba, Argentina, X5003DCE
        • Research Site
      • Florencio Varela, Argentina, 1888
        • Research Site
      • Mar del Plata, Argentina, 7600
        • Research Site
      • Mar del Plata, Argentina, B7600GNY
        • Research Site
      • Mar del Plata, Argentina, B7600FZN
        • Research Site
      • Mendoza, Argentina, 5500
        • Research Site
      • Mendoza, Argentina, M5500GIP
        • Research Site
      • Nueve de julio, Argentina, B6500EZL
        • Research Site
      • Ranelagh, Argentina, 1886
        • Research Site
      • Rosario, Argentina, S2000DEJ
        • Research Site
      • San Fernando, Argentina, 1646
        • Research Site
      • San Miguel de Tucuman, Argentina, 4000
        • Research Site
  • Austria
      • Bludenz, Austria, 6700
        • Research Site
      • Feldbach, Austria, A-8330
        • Research Site
      • Hallein, Austria, 5400
        • Research Site
      • Linz, Austria, 04020
        • Research Site
  • Belgium
      • Brussels, Belgium, 1070
        • Research Site
      • Erpent, Belgium, 5101
        • Research Site
      • Gilly, Belgium, 6060
        • Research Site
      • Jambes, Belgium, 5100
        • Research Site
      • Liège, Belgium, 4000
        • Research Site
      • Roeselare, Belgium, 8800
        • Research Site
  • Brazil
      • Botucatu, Brazil, 18618-970
        • Research Site
      • Porto Alegre, Brazil, 90610-000
        • Research Site
      • Porto Alegre, Brazil, 91350-200
        • Research Site
      • Porto Alegre, Brazil, 90470-340
        • Research Site
      • Porto Alegre, Brazil, 90035074
        • Research Site
      • Santo Andre, Brazil, 09080-110
        • Research Site
      • Sao Bernardo do Campo, Brazil, 09750-420
        • Research Site
      • Sao Paulo, Brazil, 04039-901
        • Research Site
      • Sorocaba, Brazil, 18040-425
        • Research Site
      • São Paulo, Brazil, 01228-200
        • Research Site
      • Uberlandia, Brazil, 38411-186
        • Research Site
      • Vitória, Brazil, 29055-450
        • Research Site
  • Canada
      • Quebec, Canada, G1V 4G5
        • Research Site
      • Quebec, Canada, G2J 0C4
        • Research Site
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • Research Site
      • Windsor, Ontario, Canada, N8X 1T3
        • Research Site
      • Windsor, Ontario, Canada, N8X 5A6
        • Research Site
    • Quebec
      • St Charles Borromee, Quebec, Canada, J6E 2B4
        • Research Site
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • Research Site
  • Chile
      • Curico, Chile, 3341643
        • Research Site
      • Santiago, Chile, 8380456
        • Research Site
      • Santiago, Chile, 8380453
        • Research Site
      • Talca, Chile, 3465584
        • Research Site
      • Talcahuano, Chile, 4270918
        • Research Site
  • Denmark
      • Aarhus N, Denmark, 8200
        • Research Site
      • Hvidovre, Denmark, 2650
        • Research Site
      • Kolding, Denmark, 6000
        • Research Site
      • København NV, Denmark, 2400
        • Research Site
      • Odense C, Denmark, 5000
        • Research Site
      • Roskilde, Denmark, 4000
        • Research Site
      • Silkeborg, Denmark, 8600
        • Research Site
      • Ålborg, Denmark, 9000
        • Research Site
  • Germany
      • Berlin, Germany, 14059
        • Research Site
      • Berlin, Germany, 10119
        • Research Site
      • Berlin, Germany, 12157
        • Research Site
      • Berlin, Germany, 13187
        • Research Site
      • Cottbus, Germany, 03044
        • Research Site
      • Frankfurt, Germany, 60596
        • Research Site
      • Köln, Germany, 51069
        • Research Site
      • Leipzig, Germany, 04357
        • Research Site
      • Lübeck, Germany, 23552
        • Research Site
      • Rodgau-Dudenhofen, Germany, 63110
        • Research Site
  • Italy
      • Bari, Italy, 70124
        • Research Site
      • Catania, Italy, 95123
        • Research Site
      • Ferrara, Italy, 44121
        • Research Site
      • Legnago, Italy, 37045
        • Research Site
      • Monza, Italy, 20900
        • Research Site
      • Napoli, Italy, 80131
        • Research Site
      • Padova, Italy, 35128
        • Research Site
      • Pavia, Italy, 27100
        • Research Site
      • Riccione, Italy, 47838
        • Research Site
      • Rimini, Italy, 47921
        • Research Site
      • Roma, Italy, 00168
        • Research Site
      • Roma, Italy, 00100
        • Research Site
      • Sassari, Italy, 07100
        • Research Site
  • Mexico
      • Cdmx, Mexico, 6760
        • Research Site
      • Durango, Mexico, 43080
        • Research Site
      • Guadalajara, Mexico, 44130
        • Research Site
      • Guadalajara, Mexico, 44200
        • Research Site
      • Guadalajara, Mexico, 44100
        • Research Site
      • Minatitlán, Mexico, 96730
        • Research Site
      • Monterrey, Mexico, 64460
        • Research Site
      • Sonora, Mexico, 83000
        • Research Site
      • Villahermosa, Mexico, 86035
        • Research Site
  • Norway
      • Arendal, Norway, 4841
        • Research Site
      • Hønefoss, Norway, N-3515
        • Research Site
      • Kråkeroy, Norway, N-1671
        • Research Site
      • Stavanger, Norway, N-4005
        • Research Site
      • Svelvik, Norway, 3060
        • Research Site
      • Trondheim, Norway, 7030
        • Research Site
  • Peru
      • Chancay, Peru, 15131
        • Research Site
      • Cusco, Peru
        • Research Site
      • Lima, Peru, L27
        • Research Site
      • Lima, Peru, LIMA 1
        • Research Site
      • Lima, Peru, LIMA 31
        • Research Site
      • Lima, Peru, 41
        • Research Site
      • Lima, Peru, Lima 32
        • Research Site
      • Lima, Peru, L41
        • Research Site
      • Lima, Peru, L18
        • Research Site
      • Lima, Peru, LIMA 21
        • Research Site
      • Piura, Peru
        • Research Site
  • Puerto Rico
      • Ponce, Puerto Rico, 00717
        • Research Site
      • San Juan, Puerto Rico, 00927
        • Research Site
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620039
        • Research Site
      • Izhevsk, Russian Federation, 426035
        • Research Site
      • Moscow, Russian Federation, 105077
        • Research Site
      • Novosibirsk, Russian Federation, 630008
        • Research Site
      • Novosibirsk, Russian Federation, 630084
        • Research Site
      • Omsk, Russian Federation, 644043
        • Research Site
      • Penza, Russian Federation, 440067
        • Research Site
      • Perm, Russian Federation, 614000
        • Research Site
      • Saint Petersburg, Russian Federation, 196601
        • Research Site
      • Saint-Petersburg, Russian Federation, 197022
        • Research Site
      • StPetersburg, Russian Federation, 191180
        • Research Site
      • Ulyanovsk, Russian Federation, 432009
        • Research Site
  • South Africa
      • Bloemfontein, South Africa, 9301
        • Research Site
      • Cape Town, South Africa, 7764
        • Research Site
      • Cape Town, South Africa, 7570
        • Research Site
      • Cape Town, South Africa, 1730
        • Research Site
      • Durban, South Africa, 4001
        • Research Site
      • Johannesburg, South Africa, 2001
        • Research Site
      • Lenasia Ext8, South Africa, 1820
        • Research Site
      • Mowbray, South Africa, 7700
        • Research Site
      • Parow, South Africa
        • Research Site
      • Pretoria, South Africa, 184
        • Research Site
      • Stanger, South Africa, 4450
        • Research Site
  • Spain
      • Alicante, Spain, 03114
        • Research Site
      • Alzira (Valencia), Spain, 46600
        • Research Site
      • Benalmádena (Málaga), Spain, 29631
        • Research Site
      • Cáceres, Spain, 10003
        • Research Site
      • Jerez de la Frontera, Spain, 11407
        • Research Site
      • Laredo, Spain, 39770
        • Research Site
      • Loja (Granada), Spain, 18300
        • Research Site
      • Malaga, Spain, 29010
        • Research Site
      • Marbella (Málaga), Spain, 29603
        • Research Site
      • Palma de Mallorca, Spain, 07010
        • Research Site
      • Sagunto(Valencia), Spain, 46520
        • Research Site
      • Sant Boi de Llobregat, Spain, 08830
        • Research Site
  • Sweden
      • Lund, Sweden, 221 85
        • Research Site
      • Lund, Sweden, 222 21
        • Research Site
      • Malmo, Sweden, 21152
        • Research Site
      • Stockholm, Sweden, 114 46
        • Research Site
      • Uppsala, Sweden, 75237
        • Research Site
  • United Kingdom
      • Bradford, United Kingdom, BD9 6RJ
        • Research Site
      • Chertsey, United Kingdom, KT16 0PZ
        • Research Site
      • Chester, United Kingdom, CH2 1UL
        • Research Site
      • Doncaster, United Kingdom, DN2 5LT
        • Research Site
      • Lancaster, United Kingdom, LA1 4RP
        • Research Site
      • Sheffield, United Kingdom, S5 7AU
        • Research Site
      • Wishaw, United Kingdom, ML2 0DP
        • Research Site
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Research Site
      • Huntsville, Alabama, United States, 35801
        • Research Site
      • Sheffield, Alabama, United States, 35660
        • Research Site
    • Arizona
      • Flagstaff, Arizona, United States, 86001
        • Research Site
    • California
      • Costa Mesa, California, United States, 92627
        • Research Site
      • Gold River, California, United States, 95670
        • Research Site
      • Lincoln, California, United States, 95648
        • Research Site
      • Long Beach, California, United States, 90822
        • Research Site
      • Palo Alto, California, United States, 94304
        • Research Site
      • San Diego, California, United States, 92120
        • Research Site
      • San Diego, California, United States, 92103
        • Research Site
      • San Diego, California, United States, 92117
        • Research Site
      • Upland, California, United States, 91786
        • Research Site
      • Yorba Linda, California, United States, 92886
        • Research Site
    • Colorado
      • Boulder, Colorado, United States, 80301
        • Research Site
      • Denver, Colorado, United States, 80246
        • Research Site
    • Connecticut
      • New Haven, Connecticut, United States, 06716
        • Research Site
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Research Site
      • Chiefland, Florida, United States, 32626
        • Research Site
      • Clearwater, Florida, United States, 33765
        • Research Site
      • Daytona Beach, Florida, United States, 32117
        • Research Site
      • Hialeah, Florida, United States, 33012
        • Research Site
      • Kissimmee, Florida, United States, 34741
        • Research Site
      • Leesburg, Florida, United States, 34748
        • Research Site
      • Lehigh Acres, Florida, United States, 33971
        • Research Site
      • Merritt Island, Florida, United States, 32952
        • Research Site
      • Miami, Florida, United States, 33126
        • Research Site
      • Miami, Florida, United States, 33173
        • Research Site
      • Miami, Florida, United States, 33165
        • Research Site
      • Miami, Florida, United States, 33145
        • Research Site
      • Miami, Florida, United States, 33155
        • Research Site
      • Orlando, Florida, United States, 32825
        • Research Site
      • Ormond Beach, Florida, United States, 32174
        • Research Site
      • Port Orange, Florida, United States, 32127
        • Research Site
      • Sarasota, Florida, United States, 34239
        • Research Site
      • Tampa, Florida, United States, 33603
        • Research Site
      • Tampa, Florida, United States, 33607
        • Research Site
      • Winter Park, Florida, United States, 32789
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30345
        • Research Site
      • Dacula, Georgia, United States, 30019
        • Research Site
      • Decatur, Georgia, United States, 30033
        • Research Site
      • Snellville, Georgia, United States, 30078
        • Research Site
      • Stockbridge, Georgia, United States, 30281
        • Research Site
    • Illinois
      • Aurora, Illinois, United States, 60506
        • Research Site
      • Chicago, Illinois, United States, 60607
        • Research Site
      • Peoria, Illinois, United States, 61602
        • Research Site
    • Indiana
      • Brownsburg, Indiana, United States, 46112
        • Research Site
      • Evansville, Indiana, United States, 47714
        • Research Site
      • Valparaiso, Indiana, United States, 46383
        • Research Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Research Site
    • Kansas
      • Olathe, Kansas, United States, 66061
        • Research Site
      • Topeka, Kansas, United States, 66604
        • Research Site
    • Kentucky
      • Hazard, Kentucky, United States, 41701
        • Research Site
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Research Site
      • Sunset, Louisiana, United States, 70584
        • Research Site
    • Maine
      • Biddeford, Maine, United States, 04005
        • Research Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Research Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Research Site
      • Kansas City, Missouri, United States, 64128
        • Research Site
      • Saint Charles, Missouri, United States, 63301
        • Research Site
      • Saint Louis, Missouri, United States, 63122
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Research Site
    • Nevada
      • Reno, Nevada, United States, 89506
        • Research Site
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Research Site
    • New York
      • Bronx, New York, United States, 10459
        • Research Site
      • Brooklyn, New York, United States, 11215
        • Research Site
      • New York, New York, United States, 10029
        • Research Site
      • Syracuse, New York, United States, 13210
        • Research Site
    • North Carolina
      • Gastonia, North Carolina, United States, 28054
        • Research Site
      • Hickory, North Carolina, United States, 28602
        • Research Site
      • Hickory, North Carolina, United States, 28601
        • Research Site
      • Lenoir, North Carolina, United States, 28645
        • Research Site
      • Tabor City, North Carolina, United States, 28463
        • Research Site
      • Winston-Salem, North Carolina, United States, 27104
        • Research Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Research Site
      • Cincinnati, Ohio, United States, 45242
        • Research Site
      • Columbus, Ohio, United States, 43213
        • Research Site
      • Columbus, Ohio, United States, 43207
        • Research Site
      • Dayton, Ohio, United States, 45417
        • Research Site
      • Marion, Ohio, United States, 43302
        • Research Site
      • Wooster, Ohio, United States, 44691
        • Research Site
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Research Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Research Site
      • Portland, Oregon, United States, 97220
        • Research Site
    • Pennsylvania
      • Johnstown, Pennsylvania, United States, 15905
        • Research Site
      • Scottdale, Pennsylvania, United States, 15683
        • Research Site
      • Wyomissing, Pennsylvania, United States, 19610
        • Research Site
    • Rhode Island
      • Cumberland, Rhode Island, United States, 02864
        • Research Site
      • East Providence, Rhode Island, United States, 02914
        • Research Site
      • Warwick, Rhode Island, United States, 02886
        • Research Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Research Site
      • Gaffney, South Carolina, United States, 29340
        • Research Site
      • Gaffney, South Carolina, United States, 29341
        • Research Site
      • Lancaster, South Carolina, United States, 29720
        • Research Site
      • Orangeburg, South Carolina, United States, 29118
        • Research Site
      • Rock Hill, South Carolina, United States, 29732
        • Research Site
      • Seneca, South Carolina, United States, 29678
        • Research Site
      • Spartanburg, South Carolina, United States, 29303
        • Research Site
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Research Site
      • Knoxville, Tennessee, United States, 37909
        • Research Site
      • Smyrna, Tennessee, United States, 37167
        • Research Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • Research Site
      • Austin, Texas, United States, 78758
        • Research Site
      • Baytown, Texas, United States, 77521
        • Research Site
      • Dallas, Texas, United States, 75234
        • Research Site
      • Houston, Texas, United States, 77030
        • Research Site
      • Kerrville, Texas, United States, 78028
        • Research Site
      • Lewisville, Texas, United States, 75067
        • Research Site
      • Lufkin, Texas, United States, 75904
        • Research Site
      • McKinney, Texas, United States, 75069
        • Research Site
      • McKinney, Texas, United States, 75070
        • Research Site
      • Plano, Texas, United States, 75093
        • Research Site
      • Port Arthur, Texas, United States, 77640
        • Research Site
      • Sherman, Texas, United States, 75092
        • Research Site
      • Spring, Texas, United States, 77379
        • Research Site
      • Waco, Texas, United States, 76712
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 94102
        • Research Site
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Research Site
    • Washington
      • Everett, Washington, United States, 98208
        • Research Site
      • Renton, Washington, United States, 98055
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Give their signed written informed consent to participate
  2. At least 40 years of age and no older than 80 years of age
  3. COPD patients who are symptomatic
  4. Must be receiving one or more inhaled bronchodilators as maintenance therapy
  5. Must have a documented history of COPD exacerbations

Exclusion Criteria:

  1. Current diagnosis of asthma
  2. COPD due to α1-Antitrypsin Deficiency
  3. Known active tuberculosis, lung cancer, cystic fibrosis, and significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months.
  4. Long-term-oxygen therapy (≥ 15 hours a day).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BFF MDI (PT009) 320/9.6 μg
Budesonide and Formoterol Fumarate Inhalation Aerosol - 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Drug: BFF MDI (PT009) 320/9.6 μg
Blinded Treatment
Other Names:
  • Budesonide and Formoterol Fumarate Inhalation Aerosol
EXPERIMENTAL: BFF MDI (PT009) 160/9.6 μg
Budesonide and Formoterol Fumarate Inhalation Aerosol - 80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Drug: BFF MDI (PT009) 160/9.6 μg
Blinded Treatment
Other Names:
  • Budesonide and Formoterol Fumarate Inhalation Aerosol
EXPERIMENTAL: FF MDI (PT005) 9.6 μg
Formoterol Fumarate Inhalation Aerosol - 4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Drug: FF MDI (PT005) 9.6 μg
Blinded Treatment
Other Names:
  • Formoterol Fumarate Inhalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morning Pre-dose Trough FEV1
Time Frame: at Week 12
Morning pre-dose trough FEV1 (Forced Expiratory Volume in one second) at week 12
at Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Moderate or Severe COPD Exacerbation
Time Frame: over 52 weeks
Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation over 52 weeks
over 52 weeks
Change From Baseline in Average Daily Rescue Ventolin HFA Use
Time Frame: over 12 weeks
Change from baseline in average daily rescue Ventolin HFA use over 12 weeks
over 12 weeks
Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in Saint George's Respiratory Questionnaire (SGRQ) Total Score
Time Frame: at Week 12
The SGRQ (St. George's Respiratory Questionnaire) is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of BFF MDI on health-related quality of life as compared to FF MDI 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. A decrease from baseline in SGRQ total score of 4 units or more is considered a clinically meaningful improvement in quality of life.
at Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pearl Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 29, 2016

Primary Completion (ACTUAL)

April 4, 2018

Study Completion (ACTUAL)

April 4, 2018

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

March 30, 2016

First Posted (ESTIMATE)

April 4, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT009003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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