Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF) (RAINIER)

April 28, 2017 updated by: Gilead Sciences

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on progression-free survival (PFS) as determined by either a categorical decline in forced vital capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of participants who are classified as lysyl oxidase-like-2 (LOXL2) high based on a prespecified level in serum at baseline.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

544

Phase

  • Phase 2

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

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital
      • Darlinghurst, New South Wales, Australia, 2010
        • Saint Vincents Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4000
        • Mater Adult Hospital
      • Chermside, Queensland, Australia, 4032
        • Prince Charles Hospital
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Women'S Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Belgium
    • Brussels
      • Anderlecht, Brussels, Belgium, 1070
        • ULB Erasme
    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgium, 3000
        • Universitair Ziekenhuis Leuven
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • Cliniques Universitaires UCL de Mont-Godinne
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y1E4
        • Kelowna Respiratory and Allergy Clinic
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • University of British Columbia
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Saint Joseph's Healthcare
      • Toronto, Ontario, Canada, M5G2C4
        • University Health Network
    • Quebec
      • Montreal, Quebec, Canada, H2W 1T8
        • Centre Hospitalier de L'Université de Montréal Hôtel-Dieu
      • Quebec City, Quebec, Canada, G1V4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec
  • Czechia
      • Prague 4 - Krc, Czechia, 140 59
        • Thomayerova nemocnice
    • Jihormoravsky Kraj
      • Brno, Jihormoravsky Kraj, Czechia, 625 00
        • Fakultní Nemocnice Brno
      • Jihlava, Jihormoravsky Kraj, Czechia, 689 32
        • Nemocnice Jihlava
    • Severocesky Kraj
      • Liberec, Severocesky Kraj, Czechia, 460 63
        • Krajská nemocnice Liberec a.s.
      • Ústí nad Labem, Severocesky Kraj, Czechia, 401 13
        • Masarykova nemocnice v Ústí nad Labem o.z.
    • Severomoravsky Kraj
      • Ostrava - Poruba, Severomoravsky Kraj, Czechia, 708 52
        • Fakultni Nemocnice Ostrava
    • Zapadocesky Kraj
      • Plzen, Zapadocesky Kraj, Czechia, 305 99
        • Fakultni nemocnice Plzen
  • France
    • Alsace
      • Strasbourg, Alsace, France, 67091
        • Hopitaux Universitaires de Strasbourg
    • Bretagne
      • Rennes cedex 9, Bretagne, France, 35033
        • Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou
    • Centre
      • Tours Cedex 9, Centre, France, 37044
        • Centre Hospitalier Regional et Universitaire - Hopital Bretonneau
    • Ile-de-france
      • Bobigny Cedex, Ile-de-france, France, 93009
        • Centre Hospitalier Universitaire Hopital Avicenne
      • Paris, Ile-de-france, France, 75018
        • Hopital Bichat-Claude Bernard
      • Paris Cedex 15, Ile-de-france, France, 75908
        • HEGP
    • Languedoc-roussillon
      • Montpellier cedex 5, Languedoc-roussillon, France, 34295
        • Hôpital Arnaud de Villeneuve
    • Midi-pyrenees
      • Toulouse cedex 9, Midi-pyrenees, France, 31059
        • Hopital Larrey, CHU de Toulouse, Service de Pneumologie
    • Nord Pas-de-calais
      • Lille cedex, Nord Pas-de-calais, France, 59037
        • Hopital Albert Calmette
    • Poitou-charentes
      • Nice CEDEX 1, Poitou-charentes, France, 06002
        • Centre Hospitalier Universitaire de Nice-Hôpital Pasteur
    • Provence Alpes Cote D'azur
      • Marseille Cedex 20, Provence Alpes Cote D'azur, France, 13015
        • Centre Hospitalier Universitaire Hôpital Nord
    • Rhone-Alpes
      • Grenoble Cedex 9, Rhone-Alpes, France, 38043
        • Centre Hospitalier Universitaire Grenoble Hopital Michalon
    • Rhone-aples
      • Bron, Rhone-aples, France, 69677
        • Hopital Louis Pradel
  • Germany
      • Berlin, Germany, 14165
        • Helios Klinikum Emil von Behring, Lungenklinik Heckeshorn
    • Baden-wuerttemberg
      • Freiburg, Baden-wuerttemberg, Germany, 79106
        • Universität Freiburg, Klinikum, Abt für Pneumologie
      • Heidelberg, Baden-wuerttemberg, Germany, 69126
        • Thoraxklinik am Universitätsklinikum Heidelberg
      • Mannheim, Baden-wuerttemberg, Germany, 68165
        • Ruhrlandklinik
    • Bayern
      • München, Bayern, Germany, 81377
        • Klinikum Großhadern der Ludwig-Maximilians-Universität München
    • Hessen
      • Giessen, Hessen, Germany, 35392
        • Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH
      • Immenhausen, Hessen, Germany, 34376
        • Lungenfachklinik Immenhausen
    • Niedersachsen
      • Hanover, Niedersachsen, Germany, 30625
        • Medizinische Hochschule Hannover
    • Sachsen
      • Coswig, Sachsen, Germany, 01640
        • Fachkrankenhaus Coswig
      • Leipzig, Sachsen, Germany, 04103
        • Universitätsklinikum Leipzig
  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah-Hebrew University Medical Center
      • Kfar Saba, Israel, 44281
        • Meir Medical Center
      • Petach Tikvah, Israel, 49100
        • Rabin Medical Center
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
    • Beersheba
      • Beer Sheva, Beersheba, Israel, 84100
        • Soroka University Medical Center
    • Tel Aviv
      • Tel Hashomer, Tel Aviv, Israel, 52621
        • Chaim Sheba Medical Center
  • Italy
      • Catania, Italy, 95123
        • Policlinico Universitario di Catania
      • Milano, Italy, 20132
        • San Giuseppe Hospital, Dept. of Internal Medicine
      • Modena, Italy, 41100
        • Azienda Ospedaliero-Universitaria Policlinico di Modena
      • Napoli, Italy, 80131
        • Università degli studi Federico II di Napoli
      • Palermo, Italy, 90127
        • Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)
      • Roma, Italy, 00133
        • Fondazione PTV - Policlinico Tor Vergata
      • Siena, Italy, 53100
        • Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
    • Forli-cesena
      • Forlì, Forli-cesena, Italy, 47100
        • Ospedale "G.B.Morgagni - L. Pierantoni"
    • Monza E Brianza
      • Monza, Monza E Brianza, Italy, 20052
        • Azienda Ospedaliera San Gerardo di Monza
  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 136-705
        • Korea University Anam Hospital
    • Gyeonggi-Do
      • Incheon, Gyeonggi-Do, Korea, Republic of, 405-760
        • Gachon University Gil Medical Center
    • Gyeonggi-do
      • Bucheon-si, Gyeonggi-do, Korea, Republic of, 420-767
        • Soon Chun Hyang University Hospital Bucheon
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
      • Seoul, Gyeonggi-do, Korea, Republic of, 135-710
        • Samsung Medical Center
  • Poland
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-681
        • 10 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ w Bydgoszczy
    • Lodzkie
      • Lódz, Lodzkie, Poland, 90-153
        • Samodzielny Publiczny ZOZ, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 01-138
        • Instytut Gruzlicy i Chorob Pluc
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne
    • Slaskie
      • Zabrze, Slaskie, Poland, 41-803
        • Samodzielny Publiczny Szpital Kliniczny nr 3 w Zabrzu Slaskiego Uniwersytetu Medycznego w Katowicach
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau
      • Madrid, Spain, 28006
        • Hospital Universitario La Princesa
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen Del Rocio
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Hospital Quiron Madrid
  • Switzerland
      • Basel, Switzerland, 4031
        • Universitätsspital Basel
    • Sankt Gallen
      • St. Gallen, Sankt Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen
    • Vaud
      • Lausanne, Vaud, Switzerland, CH 1011
        • Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)
  • United Kingdom
    • England
      • Birmingham, England, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • Bristol, England, United Kingdom, BS10 5NB
        • Southmead Hospital
      • Cambridge, England, United Kingdom, CB23 3RE
        • Papworth Hospital
      • Cottingham, England, United Kingdom, HU16 5JQ
        • Castle Hill Hospital
      • Exeter, England, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital
      • Leeds, England, United Kingdom, LS9 7TF
        • Saint James's University Hospital
      • Leicester, England, United Kingdom, LE3 9QP
        • Glenfield Hospital
      • Liverpool, England, United Kingdom, L9 7AL
        • Aintree University Hospitals NHS Foundation Trust
      • London, England, United Kingdom, SW3 6NP
        • Royal Brompton Hospital
      • Manchester, England, United Kingdom, M23 9LT
        • University Hospital of South Manchester NHS Foundation Trust
      • Nottingham, England, United Kingdom, NG5 1PD
        • Nottingham City Hospital
      • Oxford, England, United Kingdom, OX3 7LE
        • Churchill Hospital
      • Sheffield, England, United Kingdom, S5 7AU
        • Northern General Hospital
      • Southampton, England, United Kingdom, SO16 6YD
        • Southampton General Hospital
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH16 4TJ
        • Royal Infirmary of Edinburgh
      • Glasgow, Scotland, United Kingdom, G11 6NT
        • Glasgow Royal Infirmary
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Arizona Pulmonary Specialists, Ltd.
      • Phoenix, Arizona, United States, 85103
        • Saint Joseph's Hospital and Medical Center
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Arizona
      • Scottsdale, Arizona, United States, 85258
        • Arizona Pulmonary Specialists, Ltd.
      • Tucson, Arizona, United States, 85724
        • The University of Arizona
    • California
      • La Jolla, California, United States, 92093
        • University of California San Diego
      • Los Angeles, California, United States, 90024
        • David Geffen School of Medicine at University of California, Los Angeles
      • Sacramento, California, United States, 95817
        • University of California Davis Medical Center
      • San Francisco, California, United States, 94143
        • University of California San Francisco
      • Santa Barbara, California, United States, 93105
        • Sansum Clinic
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Connecticut
      • New Haven, Connecticut, United States, 06150
        • Yale University School Of Medicine
    • Florida
      • Clearwater, Florida, United States, 33756
        • Bay Area Chest Physicians
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida
      • Jacksonville, Florida, United States, 32209
        • University of Florida
      • Miami, Florida, United States, 33136
        • University of Miami
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Decatur, Georgia, United States, 30033
        • Southeastern Lung Care
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Iowa
      • Council Bluffs, Iowa, United States, 51503
        • Loess Hills Clinical Research Center
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
      • Louisville, Kentucky, United States, 40202
        • Kentuckiana Pulmonary Associates
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University School of Medicine
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02120
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02111
        • Tufts University School of Medicine
    • Michigan
      • Detroit, Michigan, United States, 48124
        • Henry Ford Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • CardioPulmonary Associates
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Midwest Pulmonary Consultants
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Hampshire
      • Lebanon, New Hampshire, United States, 55905
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903-0019
        • Robert Wood Johnson Medical School
      • Summit, New Jersey, United States, 07901
        • Pulmonary and Allergy Associates, PA
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College
      • Jamaica, New York, United States, 11418
        • Jamaica Hospital Medical Center
      • New Hyde Park, New York, United States, 11040
        • North Shore University Hospital
      • New York, New York, United States, 10065
        • Weill Cornell Medical College
      • New York, New York, United States, 10032
        • Columbia University
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • Rochester, New York, United States, 14620
        • University of Rochester
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43221
        • Ohio State University
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
    • Oregon
      • Portland, Oregon, United States, 97220
        • The Oregon Clinic, PC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital, Temple Lung Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Presbyterian - Montefiore
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
    • Washington
      • Everett, Washington, United States, 98201
        • Providence Everett Medical Center
      • Seattle, Washington, United States, 98195
        • University of Washington
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital and Medical College of Wisconsin

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

45 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Male or female subjects from 45 to 85 years of age
  • Definite IPF within 3 years prior to screening
  • Be able to walk at least 50 meters

Key Exclusion Criteria:

  • Significant diseases other than IPF
  • Obstructive lung disease
  • Aortic aneurysm greater than or equal to 3.5 cm in diameter

  • Treatment with immunosuppressive, cytotoxic, or antifibrotic drugs < 28 days prior to randomization are not permitted.

    • N-acetylcysteine is permitted provided the individual has been on a stable dose for > 4 weeks prior to screening
    • Concomitant use of pirfenidone or nintedanib must be in accordance with the approved prescribing instructions in the country where the site is located
  • Individuals actively listed for lung transplant are excluded. However individuals at transplant centers with long waiting times (greater than 1 year) may be permitted to enter the study after discussion with Medical Monitor.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Simtuzumab
Participants will receive simtuzumab for up to 254 weeks.
Drug: Simtuzumab
125 mg/mL single-dose vials administered subcutaneously once a week
Other Names:
  • GS-6624
PLACEBO_COMPARATOR: Simtuzumab Placebo
Participants will receive simtuzumab placebo for up to 254 weeks.
Drug: Simtuzumab placebo
Simtuzumab placebo single-dose vials administered subcutaneously once a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: Up to 148 weeks
Progression free survival (PFS) was defined as the categorical decrease in forced vital capacity (FVC) % predicted (≥ 10% relative decrease in FVC and ≥ 5% absolute decrease in FVC from baseline) with confirmation at a consecutive visit at least 2 weeks later using the same criteria.
Up to 148 weeks
PFS Among the Participants With sLOXL2 ≥ 50th Percentile
Time Frame: Up to 148 weeks
Up to 148 weeks
PFS Among the Participants With sLOXL2 ≥ 75th Percentile
Time Frame: Up to 148 weeks
Up to 148 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to 151 weeks
Overall survival was defined as the time from randomization date to death that occurred prior to the last dose date plus 30 days.
Up to 151 weeks
Overall Survival Among the Participants With sLOXL2 ≥ 50th Percentile
Time Frame: Up to 151 weeks
Up to 151 weeks
Overall Survival Among the Participants With sLOXL2 ≥ 75th Percentile
Time Frame: Up to 151 weeks
Up to 151 weeks
Relative Change From Baseline in FVC % Predicted
Time Frame: Weeks 54, 106, and 130
  • FVC was defined as the volume of air (liters) that can forcibly be blown out after taking a full breath. FVC % predicted was defined as FVC % of the participant divided by the average FVC % in the population for any person of similar age, sex, and body composition.
  • Adjusted means were from mixed model repeated measures (MMRM) model with baseline FVC % predicted, sLOXL2 level, concomitant pirfenidone/nintedanib use (never vs. ever), treatment, visit, and treatment-by-visit interaction terms, including all data up to Week 130
  • The relative change was calculated as 100% * ( value at later time point minus value at baseline ) / value at baseline, with lower values indicating a decrease and higher values indicating an increase.
Weeks 54, 106, and 130
Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations
Time Frame: Up to 148 weeks
Up to 148 weeks
Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations
Time Frame: Up to 148 weeks
Up to 148 weeks
Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death
Time Frame: Up to 148 weeks
Up to 148 weeks
Absolute Change From Baseline in 6 Minute Walk Distance (6MWD)
Time Frame: Weeks 58, 106, and 130
  • Adjusted means were from MMRM model with baseline 6MWD, FVC % predicted, sLOXL2 level, concomitant pirfenidone/nintedanib use (never vs. ever), treatment, visit, and treatment-by-visit interaction terms, including all data up to Week 130.
  • The absolute change was calculated as value at later time point minus value at baseline, with lower values indicating a decrease and higher values indicating an increase.
Weeks 58, 106, and 130
Absolute Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Score
Time Frame: Week 58, 106, and 130
  • The SGRQ is a disease-specific questionnaire designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Patients respond to questions about symptoms (frequency & severity) and impact components (social functioning and psychological disturbances resulting from airways disease). Scores range from 0 to 100, with higher scores indicating more limitations.
  • The absolute change was calculated as value at later time point minus value at baseline, with lower values indicating a decrease and higher values indicating an increase.
Week 58, 106, and 130

Collaborators and Investigators

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

Sponsor

Gilead Sciences

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

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)

January 31, 2013

Primary Completion (ACTUAL)

February 23, 2016

Study Completion (ACTUAL)

February 23, 2016

Study Registration Dates

First Submitted

January 14, 2013

First Submitted That Met QC Criteria

January 14, 2013

First Posted (ESTIMATE)

January 16, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 30, 2017

Last Update Submitted That Met QC Criteria

April 28, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-322-0207
  • 2012-001571-36 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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