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Trial record 1 of 2 for:    Simtuzumab and IPF
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Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF) (RAINIER)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01769196
Recruitment Status : Terminated (The Study was terminated due to lack of efficacy.)
First Posted : January 16, 2013
Results First Posted : April 13, 2017
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: Simtuzumab Drug: Simtuzumab placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 544 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : January 31, 2013
Actual Primary Completion Date : February 23, 2016
Actual Study Completion Date : February 23, 2016

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 Name: 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

Primary Outcome Measures :
  1. 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.

  2. PFS Among the Participants With sLOXL2 ≥ 50th Percentile [ Time Frame: Up to 148 weeks ]
  3. PFS Among the Participants With sLOXL2 ≥ 75th Percentile [ Time Frame: Up to 148 weeks ]

Secondary Outcome Measures :
  1. 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.

  2. Overall Survival Among the Participants With sLOXL2 ≥ 50th Percentile [ Time Frame: Up to 151 weeks ]
  3. Overall Survival Among the Participants With sLOXL2 ≥ 75th Percentile [ Time Frame: Up to 151 weeks ]
  4. 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.

  5. Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations [ Time Frame: Up to 148 weeks ]
  6. Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations [ Time Frame: Up to 148 weeks ]
  7. Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death [ Time Frame: Up to 148 weeks ]
  8. 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.

  9. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01769196

Hide Hide 175 study locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, United States, 85012
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85103
Arizona Pulmonary Specialists, Ltd.
Scottsdale, Arizona, United States, 85258
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
The University of Arizona
Tucson, Arizona, United States, 85724
United States, California
University of California San Diego
La Jolla, California, United States, 92093
David Geffen School of Medicine at University of California, Los Angeles
Los Angeles, California, United States, 90024
University of California Davis Medical Center
Sacramento, California, United States, 95817
University of California San Francisco
San Francisco, California, United States, 94143
Sansum Clinic
Santa Barbara, California, United States, 93105
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06150
United States, Florida
Bay Area Chest Physicians
Clearwater, Florida, United States, 33756
University of Florida
Jacksonville, Florida, United States, 32209
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
University of Miami
Miami, Florida, United States, 33136
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
Tampa General Hospital
Tampa, Florida, United States, 33606
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Southeastern Lung Care
Decatur, Georgia, United States, 30033
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago
Chicago, Illinois, United States, 60637
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Iowa
Loess Hills Clinical Research Center
Council Bluffs, Iowa, United States, 51503
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States, 40202
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Tufts University School of Medicine
Boston, Massachusetts, United States, 02111
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48124
United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
CardioPulmonary Associates
Chesterfield, Missouri, United States, 63017
Saint Luke's Midwest Pulmonary Consultants
Kansas City, Missouri, United States, 64111
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 55905
United States, New Jersey
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903-0019
Pulmonary and Allergy Associates, PA
Summit, New Jersey, United States, 07901
United States, New York
Albany Medical College
Albany, New York, United States, 12208
Jamaica Hospital Medical Center
Jamaica, New York, United States, 11418
North Shore University Hospital
New Hyde Park, New York, United States, 11040
Mount Sinai School of Medicine
New York, New York, United States, 10029
Columbia University
New York, New York, United States, 10032
Weill Cornell Medical College
New York, New York, United States, 10065
University of Rochester
Rochester, New York, United States, 14620
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43221
Miami Valley Hospital
Dayton, Ohio, United States, 45409
United States, Oregon
The Oregon Clinic, PC
Portland, Oregon, United States, 97220
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Temple University Hospital, Temple Lung Center
Philadelphia, Pennsylvania, United States, 19140
University of Pittsburgh Presbyterian - Montefiore
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
United States, Washington
Providence Everett Medical Center
Everett, Washington, United States, 98201
University of Washington
Seattle, Washington, United States, 98195
United States, Wisconsin
Froedtert Hospital and Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
Saint Vincents Hospital
Darlinghurst, New South Wales, Australia, 2010
Australia, Queensland
Mater Adult Hospital
Brisbane, Queensland, Australia, 4000
Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
ULB Erasme
Anderlecht, Brussels, Belgium, 1070
Universitair Ziekenhuis Leuven
Leuven, Flemish Brabant, Belgium, 3000
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, Namur, Belgium, 5530
Canada, British Columbia
Kelowna Respiratory and Allergy Clinic
Kelowna, British Columbia, Canada, V1Y1E4
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
University of British Columbia
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
Saint Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
University Health Network
Toronto, Ontario, Canada, M5G2C4
Canada, Quebec
Centre Hospitalier de L'Université de Montréal Hôtel-Dieu
Montreal, Quebec, Canada, H2W 1T8
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Quebec City, Quebec, Canada, G1V4G5
Fakultní nemocnice Brno
Brno, Jihormoravsky Kraj, Czechia, 625 00
Nemocnice Jihlava
Jihlava, Jihormoravsky Kraj, Czechia, 689 32
Krajská nemocnice Liberec a.s.
Liberec, Severocesky Kraj, Czechia, 460 63
Masarykova nemocnice v Ústí nad Labem o.z.
Ústí nad Labem, Severocesky Kraj, Czechia, 401 13
Fakultní Nemocnice Ostrava
Ostrava - Poruba, Severomoravsky Kraj, Czechia, 708 52
Fakultní nemocnice Plzen
Plzen, Zapadocesky Kraj, Czechia, 305 99
Thomayerova nemocnice
Prague 4 - Krc, Czechia, 140 59
Hôpitaux Universitaires de Strasbourg
Strasbourg, Alsace, France, 67091
Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou
Rennes cedex 9, Bretagne, France, 35033
Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau
Tours Cedex 9, Centre, France, 37044
Centre Hospitalier Universitaire Hôpital Avicenne
Bobigny Cedex, Ile-de-france, France, 93009
Paris Cedex 15, Ile-de-france, France, 75908
Hôpital Bichat-Claude Bernard
Paris, Ile-de-france, France, 75018
Hôpital Arnaud de Villeneuve
Montpellier cedex 5, Languedoc-roussillon, France, 34295
Hôpital Larrey, CHU de Toulouse, Service de Pneumologie
Toulouse cedex 9, Midi-pyrenees, France, 31059
Hôpital Albert Calmette
Lille cedex, Nord Pas-de-calais, France, 59037
Centre Hospitalier Universitaire de Nice-Hôpital Pasteur
Nice CEDEX 1, Poitou-charentes, France, 06002
Centre Hospitalier Universitaire Hôpital Nord
Marseille Cedex 20, Provence Alpes Cote D'azur, France, 13015
Centre Hospitalier Universitaire Grenoble Hopital Michalon
Grenoble Cedex 9, Rhone-Alpes, France, 38043
Hôpital Louis Pradel
Bron, Rhone-aples, France, 69677
Universität Freiburg, Klinikum, Abt für Pneumologie
Freiburg, Baden-wuerttemberg, Germany, 79106
Thoraxklinik am Universitätsklinikum Heidelberg
Heidelberg, Baden-wuerttemberg, Germany, 69126
Mannheim, Baden-wuerttemberg, Germany, 68165
Klinikum Großhadern der Ludwig-Maximilians-Universität München
München, Bayern, Germany, 81377
Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH
Giessen, Hessen, Germany, 35392
Lungenfachklinik Immenhausen
Immenhausen, Hessen, Germany, 34376
Medizinische Hochschule Hannover
Hanover, Niedersachsen, Germany, 30625
Fachkrankenhaus Coswig
Coswig, Sachsen, Germany, 01640
Universitätsklinikum Leipzig
Leipzig, Sachsen, Germany, 04103
Helios Klinikum Emil von Behring, Lungenklinik Heckeshorn
Berlin, Germany, 14165
Soroka University Medical Center
Beer Sheva, Beersheba, Israel, 84100
Chaim Sheba Medical Center
Tel Hashomer, Tel Aviv, Israel, 52621
Hadassah-Hebrew University Medical Center
Jerusalem, Israel, 91120
Meir Medical Center
Kfar Saba, Israel, 44281
Rabin Medical Center
Petach Tikvah, Israel, 49100
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Ospedale "G.B.Morgagni - L. Pierantoni"
Forlì, Forli-cesena, Italy, 47100
Azienda Ospedaliera San Gerardo di Monza
Monza, Monza E Brianza, Italy, 20052
Policlinico Universitario di Catania
Catania, Italy, 95123
San Giuseppe Hospital, Dept. of Internal Medicine
Milano, Italy, 20132
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, Italy, 41100
Università degli studi Federico II di Napoli
Napoli, Italy, 80131
Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)
Palermo, Italy, 90127
Fondazione PTV - Policlinico Tor Vergata
Roma, Italy, 00133
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Siena, Italy, 53100
Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, Korea, Republic of, 420-767
Gachon University Gil Medical Center
Incheon, Gyeonggi-Do, Korea, Republic of, 405-760
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Samsung Medical Center
Seoul, Gyeonggi-do, Korea, Republic of, 135-710
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Korea University Anam Hospital
Seoul, Korea, Republic of, 136-705
Asan Medical Center
Seoul, Korea, Republic of, 138-736
10 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ w Bydgoszczy
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-681
Samodzielny Publiczny ZOZ, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego
Lódz, Lodzkie, Poland, 90-153
Instytut Gruzlicy i Chorób Pluc
Warszawa, Mazowieckie, Poland, 01-138
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomorskie, Poland, 80-952
Samodzielny Publiczny Szpital Kliniczny nr 3 w Zabrzu Slaskiego Uniwersytetu Medycznego w Katowicach
Zabrze, Slaskie, Poland, 41-803
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33011
Hospital Quirón Madrid
Pozuelo de Alarcón, Madrid, Spain, 28223
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital Universitario La Princesa
Madrid, Spain, 28006
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Kantonsspital St. Gallen
St. Gallen, Sankt Gallen, Switzerland, 9007
Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)
Lausanne, Vaud, Switzerland, CH 1011
Universitätsspital Basel
Basel, Switzerland, 4031
United Kingdom
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom, B9 5SS
Southmead Hospital
Bristol, England, United Kingdom, BS10 5NB
Papworth Hospital
Cambridge, England, United Kingdom, CB23 3RE
Castle Hill Hospital
Cottingham, England, United Kingdom, HU16 5JQ
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom, EX2 5DW
Saint James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Glenfield Hospital
Leicester, England, United Kingdom, LE3 9QP
Aintree University Hospitals NHS Foundation Trust
Liverpool, England, United Kingdom, L9 7AL
Royal Brompton Hospital
London, England, United Kingdom, SW3 6NP
University Hospital of South Manchester NHS Foundation Trust
Manchester, England, United Kingdom, M23 9LT
Nottingham City Hospital
Nottingham, England, United Kingdom, NG5 1PD
Churchill Hospital
Oxford, England, United Kingdom, OX3 7LE
Northern General Hospital
Sheffield, England, United Kingdom, S5 7AU
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom, EH16 4TJ
Glasgow Royal Infirmary
Glasgow, Scotland, United Kingdom, G11 6NT
Sponsors and Collaborators
Gilead Sciences
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Study Director: Gilead Study Director Gilead Sciences

Publications of Results:
Humphries SM, O'Riordan TG, Zhang JJ, Bayly S, Sood R, Hayden A, Lynch DA; Relationship Baseline Fibrosis Score to Lung Function in A Clinical Trial Population with Idiopathic Pulmonary Fibrosis. ATS International Conference, 2016 May 13-18, San Francisco CA.
Raghu G, Brown K, Collard H, Lederer D, Martinez F, Noble P, Song JW, Wells A, Whelan T, Moreau E, Patterson S, Bayly S, Chien J, Zhang J, O'Riordan T; Simtuzumab in Idiopathic Pulmonary Fibrosis: Results of a Randomized Clinical Trial. ERS Congress, 2016 September 3-7, London, UK.
Raghu G, Brown KK, Collard HR, Lederer DJ, Martinez FJ, Noble PW, Song JW, Wells AU, Whalen TP, Lambert L, Chien JW, Zhang JJ, O'Riordan TG; Simtuzumab in Idiopathic Pulmonary Fibrosis (IPF): Baseline Demographic and Lung Function Data from a Clinical Trial. ATS International Conference, 2016 May 13-18, San Francisco CA.

Other Publications:
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Responsible Party: Gilead Sciences Identifier: NCT01769196    
Other Study ID Numbers: GS-US-322-0207
2012-001571-36 ( EudraCT Number )
First Posted: January 16, 2013    Key Record Dates
Results First Posted: April 13, 2017
Last Update Posted: May 30, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gilead Sciences:
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial