A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis

Last updated: June 6, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Active - Recruiting

Phase

2

Condition

Idiopathic Pulmonary Fibrosis

Cystic Fibrosis

Lung Injury

Treatment

BI 1839100

Placebo

Clinical Study ID

NCT06360094
1490-0004
2023-510249-79-00
U1111-1301-1311
  • Ages > 18
  • All Genders

Study Summary

Adults 40 years of age and older with idiopathic pulmonary fibrosis (IPF) or 18 years and older with progressive pulmonary fibrosis (PPF) can participate in this study. Only people who have a chronic cough can take part. The purpose of this study is to find out how well BI 1839100 helps reduce coughing in people with IPF or PPF.

Participants who have IPF are put into 4 groups by chance. Participants in 3 groups get different doses of BI 1839100. Participants in 1 group get placebo. Placebo looks like BI 1839100 but does not contain any medicine. Participants take the treatment for 3 months. After 1 month of treatment, participants who take the highest dose will have coughing measured to find out if the medicine works. If it does not work, the study may be stopped. Participants who have IPF are in the study for slightly longer than 4 months. During this time, they visit the study site 7 times. This study will also measure the effects of BI 1839100 on coughing and lung function in a smaller group of people with PPF.

During the study, coughing is measured over 24 hours about once per month using a portable device given to participants to use during the study. Participants fill in questionnaires about their coughing. Doctors also perform breathing tests that measure how well the lungs are working at the site visits. Researchers compare the results between participants who take BI 1839100 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects.

Eligibility Criteria

Inclusion

Inclusion Criteria

For Idiopathic Pulmonary Fibrosis (IPF) cohort:

  • Minimum age: 40 years

  • Diagnosis of IPF

  • Chronic cough (>8 weeks prior to Visit 1) attributed to IPF and refractory to treatment for known causes (Principal Investigator (PI) assessment)

  • Cough Severity visual analogue scale (VAS) ≥30 mm at Visit 1 and Visit 2B

  • Forced vital capacity (FVC) ≥45% of predicted normal at Visit 1

  • Diffusing capacity of the lungs for carbon monoxide (DLCO) >25% of predicted normal at Visit 1

  • Patients may be either:

  • On stable therapy with nintedanib or pirfenidone for ≥12 weeks prior to Visit 1 and are planning to stay on this background treatment for the whole trial duration. Combination of nintedanib plus pirfenidone will not be allowed

  • Not on therapy with nintedanib or pirfenidone for ≥12 weeks prior to Visit 1 (either antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start AF treatment during the trial. It is not permitted to delay nintedanib or pirfenidone therapy for the purpose of participating in this trial

  • Patients aged ≥40 years when signing the informed consent

For Progressive Pulmonary Fibrosis (PPF) cohort:

  • Minimum age: 18 years

  • Diagnosis of PPF

  • Chronic cough (>8 weeks prior to Visit 1) attributed to PPF, refractory to treatment for known causes (PI assessment)

  • Cough Severity VAS ≥30 mm at Visit 1 and Visit 2B

  • FVC ≥45% of predicted normal at Visit 1

  • DLCO ≥25% of predicted normal at Visit 1

  • If receiving immunomodulatory therapy for interstitial lung disease (ILD), allowed medications include tacrolimus, mycophenolate mofetil, or azathioprine (stable dose for 12 weeks prior to Visit 1)

  • Patients may be either:

  • On a stable therapy with nintedanib for ≥12 weeks prior to Visit 1 and are planning to stay on this background treatment for the whole trial duration

  • Not on a therapy with nintedanib for ≥12 weeks prior to Visit 1 (either AF-treatment naïve or previously discontinued) and do not plan to start or re-start AF treatment during the trial. It is not permitted to delay nintedanib or pirfenidone therapy for the purpose of participating in this trial

  • Patients aged >18 years when signing the informed consent Further inclusion criteria apply.

Exclusion criteria for IPF and PPF cohorts:

  • Acute exacerbation of IPF/PPF within 12 weeks prior to Visit 1

  • Forced expiratory volume in 1 second (Forced expiratory volume in 1 second (FEV1))/FVC <0.7 at Visit 1

  • Known reversible airflow obstruction/response to bronchodilators

  • In the opinion of the Investigator, other clinically significant pulmonary abnormalities, including primary bronchitic and bronchiectatic disorder

  • Upper or lower respiratory tract infection within 4 weeks prior to Visit 1

  • Ongoing chronic pulmonary infection (e.g. mycobacterial or fungal disease)

  • Current smokers (tobacco use within the 6 months prior to Visit 1)

  • Initiation or change in supplemental oxygen requirement during 4 weeks prior to Visit 1 Further exclusion criteria apply.

Study Design

Total Participants: 230
Treatment Group(s): 2
Primary Treatment: BI 1839100
Phase: 2
Study Start date:
August 28, 2024
Estimated Completion Date:
March 25, 2026

Connect with a study center

  • Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553

    C.a.b.a, C1027AAP
    Argentina

    Site Not Available

  • CEDIC - Centro de Investigacion Clinica

    Caba, C1060ABN
    Argentina

    Site Not Available

  • Centro de Investigación Clinica Belgrano

    Caba, 1425
    Argentina

    Site Not Available

  • Hospital Britanico de Buenos Aires

    Caba, 1280AEB
    Argentina

    Site Not Available

  • Consultorios Médicos del Buen Ayre

    Capital Federal, 1425
    Argentina

    Site Not Available

  • Canberra Hospital

    Canberra, Australian Capital Territory 2605
    Australia

    Site Not Available

  • Royal Prince Alfred Hospital

    Camperdown, Sydney, New South Wales 2050
    Australia

    Site Not Available

  • Macquarie University

    Macquarie Park, New South Wales 2109
    Australia

    Site Not Available

  • Launceston Respiratory & Sleep Centre

    Launceston, Tasmania 7250
    Australia

    Active - Recruiting

  • Lung Research Victoria

    Footscray, Victoria 3011
    Australia

    Active - Recruiting

  • Austin Hospital

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Institute for Respiratory Health

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Medical University of Graz State Hospital - University Hospital Graz

    Graz, 8036
    Austria

    Site Not Available

  • Krems University Hospital

    Krems, 3500
    Austria

    Site Not Available

  • Hospital Elisabethinen Linz

    Linz,
    Austria

    Site Not Available

  • Kepler Univ. Klinikum Linz

    Linz, 4020
    Austria

    Site Not Available

  • Clinic Floridsdorf

    Vienna, 1210
    Austria

    Site Not Available

  • Klinikum Wels - Grieskirchen GmbH

    Wels, 4600
    Austria

    Site Not Available

  • Brussels - UNIV Saint-Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • UNIV UZ Gent

    Gent, 9000
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000
    Belgium

    Site Not Available

  • Liège - HOSP CHR de la Citadelle

    Liège, 4000
    Belgium

    Site Not Available

  • Serviços Medicos Respirar Sul Fluminense

    Barra Mansa, 27323240
    Brazil

    Site Not Available

  • Faculdade de Medicina de Botucatu - UNESP

    Botucatu, 18618-687
    Brazil

    Site Not Available

  • CLARE - Clinica de Pneumologia

    Goiania, 74110-030
    Brazil

    Site Not Available

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, 90035-074
    Brazil

    Site Not Available

  • Netspiro Clinica Medica Ltda - Respsono

    Sao Bernardo do Campo, 09750-420
    Brazil

    Site Not Available

  • Hospital Alemao Oswaldo Cruz

    Sao Paulo, 01327-001
    Brazil

    Site Not Available

  • Hospital das Clinicas da FMUSP

    São Paulo, 05403-000
    Brazil

    Site Not Available

  • Gordon & Leslie Diamond Health Care Centre (UBC)

    Vancouver, British Columbia V5Z 1M9
    Canada

    Active - Recruiting

  • St. Paul's Hospital (Vancouver)

    Vancouver, British Columbia V6Z 1Y6
    Canada

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    Hamilton, Ontario L8N 4A6
    Canada

    Active - Recruiting

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec H2X 3E4
    Canada

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  • CIC Mauricie Inc.

    Trois-Rivieres, Quebec G8T 7A1
    Canada

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    Beijing, 100020
    China

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    Changsha, 410011
    China

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    Chengdu, 610072
    China

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  • West China Hospital

    Chengdu, 610041
    China

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  • First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120
    China

    Active - Recruiting

  • Hangzhou First People's Hospital

    Hangzhou, 310006
    China

    Site Not Available

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    Hangzhou, 310016
    China

    Site Not Available

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    Hangzhou, 310013
    China

    Active - Recruiting

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    Hefei, 230001
    China

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  • Nanjing Drum Tower Hospital

    Nanjing, 210008
    China

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  • Shanghai Chest Hospital

    Shanghai, 200030
    China

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    Shanghai, 200433
    China

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    Shenyang, 110000
    China

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    Tianjin, 30052
    China

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  • Affiliated Hospital, Xuzhou Medical college

    Xuzhou, 221009
    China

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  • Thomayer University Hospital

    Prague, 140 59
    Czechia

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    Odense, 5000
    Denmark

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    Helsinki, 00029
    Finland

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    Oulu, 90220
    Finland

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    Turku, 20520
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    Angers, 49933
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    Bobigny, 93000
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    Caen, 14033
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    Caen, 14033
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    La Tronche, 38700
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    Lille, 59037
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    Marseille, 13915
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    Marseille, 13915
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    Nantes, 44093
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    Paris, 75877
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    Pessac, 33604
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    Rouen, 76031
    France

    Site Not Available

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    Tours, 37000
    France

    Active - Recruiting

  • Universitätsklinikum Aachen, AöR

    Aachen, 52074
    Germany

    Active - Recruiting

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    Bamberg, 96049
    Germany

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    Berlin, 12351
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    Essen, 45239
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    Freiburg, 79106
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    Hamburg, 20246
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    Hamburg, 20246
    Germany

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  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Active - Recruiting

  • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

    Heidelberg, 69126
    Germany

    Active - Recruiting

  • Krankenhaus Bethanien gGmbH

    Solingen, 42699
    Germany

    Active - Recruiting

  • Helios Hanseklinikum Stralsund

    Stralsund, 18435
    Germany

    Site Not Available

  • Robert Bosch Gesellschaft für medizinische Forschung mbH

    Stuttgart, 70376
    Germany

    Site Not Available

  • Klinikum Würzburg Mitte gGmbH

    Würzburg, 97074
    Germany

    Site Not Available

  • Univ. Gen. Hosp. of Ioannina

    Ioannina, 45 500
    Greece

    Site Not Available

  • Univ. Gen. Hosp. of Patras

    Patras, 26504
    Greece

    Active - Recruiting

  • Hospital of Heraklion (PAGNI)

    Voutes, 71500
    Greece

    Active - Recruiting

  • Koranyi National Institute For Pulmonolgy

    Budapest, 1121
    Hungary

    Site Not Available

  • A. O. Universitaria Careggi

    Firenze, 50137
    Italy

    Site Not Available

  • Ospedale Colonnello D Avanzo

    Foggia, 71100
    Italy

    Site Not Available

  • Ospedale G.B. Morgagni

    Forli', 47121
    Italy

    Site Not Available

  • Ospedale G.B. Morgagni - L. Pierantoni AUSL Forlì

    Forli', 47121
    Italy

    Site Not Available

  • Azienda Ospedaliera San Martino

    Genova, 16132
    Italy

    Site Not Available

  • Osp. S. Giuseppe Fatebenefratelli

    Milano, 20123
    Italy

    Active - Recruiting

  • Ospedale Classificato San Giuseppe

    Milano, 20123
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria di Padova

    Padova, 35128
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

    Roma, 00189
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, 00168
    Italy

    Active - Recruiting

  • Pol. Universitario Tor Vergata

    Roma, 00133
    Italy

    Active - Recruiting

  • Poli Univ A. Gemelli

    Roma, 00168
    Italy

    Site Not Available

  • Tosei General Hospital

    Aichi, Seto, 489-8642
    Japan

    Site Not Available

  • Chiba University Hospital

    Chiba, Chiba, 260-8677
    Japan

    Site Not Available

  • University of Fukui Hospital

    Fukui, Yoshida-gun, 910-1193
    Japan

    Active - Recruiting

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582
    Japan

    Active - Recruiting

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, Fukuoka, 810-8563
    Japan

    Active - Recruiting

  • Sapporo Medical University Hospital

    Hokkaido, Sapporo, 060-8543
    Japan

    Active - Recruiting

  • National Hospital Organization Himeji Medical Center

    Hyogo, Himeji, 670-8520
    Japan

    Active - Recruiting

  • Kanagawa Cardiovascular and Respiratory Center

    Kanagawa, Yokohama, 236-0051
    Japan

    Active - Recruiting

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501
    Japan

    Site Not Available

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Osaka, Sakai, 591-8555
    Japan

    Site Not Available

  • Hamamatsu University Hospital

    Shizuoka, Hamamatsu, 431-3192
    Japan

    Site Not Available

  • Tokushima University Hospital

    Tokushima, Tokushima, 770-8503
    Japan

    Active - Recruiting

  • Kyorin University Hospital

    Tokyo, Mitaka, 181-8611
    Japan

    Site Not Available

  • Toho University Omori Medical Center

    Tokyo, Ota-ku, 143-8541
    Japan

    Active - Recruiting

  • Center Hospital of the National Center for Global Health and Medicine

    Tokyo, Shinjuku-ku, 162-8655
    Japan

    Active - Recruiting

  • National Center for Global Health and Medicine

    Tokyo, Shinjuku-ku, 162-8655
    Japan

    Active - Recruiting

  • The Catholic University of Korea, Bucheon St.Mary's Hospital

    Bucheon, 14647
    Korea, Republic of

    Site Not Available

  • Inje University Haeundae Paik Hospital

    Busan, 48108
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam, 13620
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Inje University Sanggye Paik Hospital

    Seoul, 01757
    Korea, Republic of

    Completed

  • Kyung Hee University Hospital

    Seoul, 02447
    Korea, Republic of

    Site Not Available

  • Severance Hospital

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Soonchunhyang University Hospital Seoul

    Seoul, 04401
    Korea, Republic of

    Site Not Available

  • Hospital Sultan Idris Shah Serdang

    Kajang, 43000
    Malaysia

    Active - Recruiting

  • Institut Perubatan Respiratori

    Kuala Lumpur, 53000
    Malaysia

    Active - Recruiting

  • Sarawak General Hospital

    Kuching, Sarawak, 93586
    Malaysia

    Site Not Available

  • Amphia Ziekenhuis

    Breda, 4818 CK
    Netherlands

    Site Not Available

  • Erasmus Medisch Centrum-ROTTERDAM-50697

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • Christchurch Hospital

    Christchurch, 8011
    New Zealand

    Active - Recruiting

  • Waikato Hospital

    Hamilton, 3240
    New Zealand

    Active - Recruiting

  • Greenlane Clinical Centre

    One Tree Hill, Auckland, 1051
    New Zealand

    Active - Recruiting

  • Haukeland Universitetssykehus

    Bergen, N-5021
    Norway

    Active - Recruiting

  • Akershus Universitetssykehus HF

    Lørenskog, 1478
    Norway

    Site Not Available

  • Oslo Universitetssykehus HF, Rikshospitalet

    Oslo, N-0372
    Norway

    Active - Recruiting

  • University Clinical Hospital in Bialystok I

    Bialystok, 15-540
    Poland

    Site Not Available

  • Alergopneuma Medical Center

    Swidnik, 21040
    Poland

    Site Not Available

  • Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa

    Warsaw, 01-138
    Poland

    Site Not Available

  • Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa

    Warszawa, 01-138
    Poland

    Site Not Available

  • Singapore General Hospital

    Singapore, 169608
    Singapore

    Active - Recruiting

  • Tan Tock Seng Hospital

    Singapore, 308433
    Singapore

    Site Not Available

  • Hospital General Universitario de Alicante

    Alicante, 03010
    Spain

    Site Not Available

  • Hospital Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital de Galdakao

    Galdakao, 48960
    Spain

    Active - Recruiting

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, 08907
    Spain

    Site Not Available

  • Hospital Universitario Infanta Leonor

    Madrid, 28031
    Spain

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  • Hospital Virgen de la Victoria

    Malaga, 29010
    Spain

    Active - Recruiting

  • Hospital Central de Asturias

    Oviedo, 33011
    Spain

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  • Hospital Quirónsalud Madrid

    Pozuelo de Alarcón, 28223
    Spain

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  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008
    Spain

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  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • Hospital Virgen del Rocío

    Sevilla, 41013
    Spain

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  • Skånes universitetssjukhus, Lund

    Lund, 221 85
    Sweden

    Active - Recruiting

  • CTC Clinical Trial Consultants AB

    Uppsala, 752 37
    Sweden

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  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung, 83301
    Taiwan

    Site Not Available

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    Kaohsiung, 807
    Taiwan

    Active - Recruiting

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    Taichung, 40705
    Taiwan

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  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

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    TaoYuan, 333
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    Bangkok, 10330
    Thailand

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    Khon Kaen, 40002
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    Ratchatewi, 10400
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    Songkhla, 90110
    Thailand

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    Cottingham, HU16 5JQ
    United Kingdom

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    Exeter, EX2 5DW
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    Lancaster, LA1 4RP
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    London, SW3 6NP
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    Manchester, M23 9LT
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    Southampton, SO16 6YD
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    Birmingham, Alabama 35294
    United States

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  • The Medical Research Group

    Fresno, California 93720
    United States

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    Lakewood, Colorado 78539
    United States

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    Lakewood, Colorado 80228
    United States

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    Clearwater, Florida 33765
    United States

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    Gainesville, Florida 32608
    United States

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    Kissimmee, Florida 34746
    United States

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    Chicago, Illinois 60611
    United States

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    West Des Moines, Iowa 50266
    United States

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    North Dartmouth, Massachusetts 02747
    United States

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    Warren, Michigan 48088
    United States

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    Warren, Michigan 48088
    United States

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    Gulfport, Mississippi 39501
    United States

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    Reno, Nevada 89502
    United States

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    Mount Kisco, New York 10549
    United States

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    New York, New York 10032
    United States

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    New York, New York 10032
    United States

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    New York, New York 10029
    United States

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    New York, New York 10029
    United States

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    Durham, North Carolina 27710
    United States

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    New Bern, North Carolina 28562
    United States

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    Winston-Salem, North Carolina 27103
    United States

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    Winston-Salem, North Carolina 27103
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    Winston-Salem, North Carolina 27103
    United States

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    Oklahoma City, Oklahoma 73019
    United States

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    DuBois, Pennsylvania 15801
    United States

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    Philadelphia, Pennsylvania 19140
    United States

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    Philadelphia, Pennsylvania 19140
    United States

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    East Providence, Rhode Island 02914
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    Charleston, South Carolina 29406
    United States

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    Spartanburg, South Carolina 29303
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    Dallas, Texas 75390
    United States

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    Edinburg, Texas 78539
    United States

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  • Pulmonary and Sleep Center of the Valley

    McAllen, Texas 78504
    United States

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  • University of Utah Health Sciences Center

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Pulmonary Associates of Richmond, Inc.

    Richmond, Virginia 23230
    United States

    Active - Recruiting

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