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A Study to Test Whether Different Doses of BI 1291583 Help People With Bronchiectasis

Primary Purpose

Bronchiectasis

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BI 1291583
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Male or female patients: Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method. A list of contraception methods meeting these criteria is provided in the patient information.

Men participating in this clinical trial must use male contraception (condom or sexual abstinence) if their sexual partner is a WOCBP.

  • Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation.
  • Age of patients when signing the informed consent ≥18 (for Korea: ≥19) and ≤85 years.
  • Clinical history consistent with bronchiectasis (e.g., cough, chronic sputum production and/or recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by computed tomography (CT) scan. Subjects whose past chest radiographic image records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than 5 years.
  • History of pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, patients must have had either:

    • at least 2 exacerbations, or
    • at least 1 exacerbation and a St. George´s Respiratory Questionnaire (SGRQ) Symptoms score of >40 at screening visit 1.

For patients on stable oral or inhaled antibiotics as chronic treatment for bronchiectasis, at least one exacerbation must have occurred since initiation of stable antibiotics.

- Current sputum producers with a history of chronic expectoration who are able to provide a spontaneous (not induced) sputum sample at Screening Visit 1.

Exclusion Criteria:

Laboratory and medical examination

  • Aspartate Aminotransferase (AST) and / or Alanine Aminotransferase (ALT) >3.0 x upper limit of normal (ULN) at Visit 1, or moderate or severe liver disease (defined by Child-Pugh score B or C hepatic impairment).
  • Estimated glomerular filtration rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula < 30 mL/min at Visit 1.
  • An absolute blood neutrophil count <1,000/mm^3 at Visit 1 (equivalent to <1,000 cells/µL or <109 cells/L).
  • Any findings in the medical examination and/or laboratory value assessed at Screening Visit 1 or during screening period, that in the opinion of the investigator may put the patient at risk by participating in the trial.
  • Positive serological tests for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection, or known infection status.

Concomitant diagnosis and therapy

  • A current diagnosis of:

    • Cystic Fibrosis
    • Hypogammaglobulinemia
    • Common variable immunodeficiency
    • α1-antitrypsin deficiency being treated with augmentation therapy
    • Allergic bronchopulmonary aspergillosis being treated or requiring treatment
    • Tuberculosis or non-tuberculous mycobacterial infection being treated or requiring treatment according to local guidelines
    • Palmoplantar keratosis; or keratoderma climactericum
    • Hypothyroidism, myxedema, chronic lymphedema with associated hyperkeratosis of the skin, acrocyanosis. If a subject has hypothyroidism but is treated and compensated, the subject is allowed into the trial
    • Psoriasis affecting palms and soles; or body surface area for psoriasis ≥ 10%
    • Reactive arthritis (Reiter's syndrome); keratoderma blennorrhagicum
    • Pityriasis rubra pilaris
    • Atopic dermatitis affecting palms and soles; or body surface area for atopic dermatitis ≥ 10%
    • Active extensive verruca vulgaris, as per investigator's discretion
    • Active fungal infection of hand and/or feet not adequately treated, or not responsive to antifungal therapy, as per investigator's discretion.
  • Acute respiratory infection (including SARS-CoV-2 infection), or any other acute infection requiring systemic or inhaled therapy within 4 weeks prior Visit 1 and throughout screening.
  • Any evidence of a concomitant disease, such as Papillon-Lefevre Syndrome, relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal disorders, or patients who are immunocompromised with a higher risk of invasive pneumococcal disease or other invasive opportunistic infections (such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis), that in the opinion of the investigator, may put the patient at risk by participating in the study.
  • Received any live attenuated vaccine within 4 weeks prior to Visit 2.
  • Medical conditions associated with periodontal disease (to be evaluated by a periodontist or dentist):

    • Any tooth that can potentially cause pain or infection as noted in the oral exam unless they are corrected before the study (e.g. pulp necrosis).
    • Severe periodontal disease defined as with pocket depth measurements ≥ 6 mm on 2 or more teeth.
    • Class-3 mobility or Class-3 furcation involvement.
    • Scheduled tooth extraction during the study period.
  • Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.

Further exclusion criteria apply

Sites / Locations

  • Phoenix Medical Group
  • Newport Native MD, Inc
  • University of California Davis
  • Central Florida Pulmonary Group
  • Malcom Randall VA Medical Center
  • University of Florida College of Medicine
  • New York University Langone Medical Center
  • NewYork-Presbyterian/Weill Cornell Medical Center
  • Southeastern Research Center
  • University of Cincinnati
  • Medical University of South Carolina
  • Institute for Translational Oncology Research
  • Metroplex Pulmonary & Sleep Center
  • Diagnostics Research Group
  • University of Texas Health Science Center at Tyler
  • Macquarie University
  • Westmead Hospital
  • Lung Research Queensland
  • Mater Research Institute
  • Institute for Respiratory Health
  • Trialswest
  • AZ Sint-Jan Brugge
  • UNIV UZ Gent
  • UZ Leuven
  • Medical Center "Zdrave-1"
  • Medica Center Hera - Montana Branch
  • Medical Center ReSpiro Ltd
  • SHATPFD "Dr. Dimitar Gramatikov"
  • Medical Center Hera EOOD
  • Jewish General Hospital
  • Centre Hospitalier de l'Universite de Montreal (CHUM)
  • IUCPQ (Laval University)
  • Pulmonary Private Practice Kralupy
  • The First Pulmonary Private Practice
  • Hvidovre Hospital
  • Copenhagen University Hospital, Rigshospitalet
  • Odense University Hospital
  • Sjællands Universitetshospital
  • Vejle University Hospital
  • Aalborg Sygehus Syd
  • HOP Amiens-Picardie Sud
  • HOP Arnaud de Villeneuve
  • HOP Cochin
  • HOP Pontchaillou
  • HOP Perharidy
  • Charité - Universitätsmedizin Berlin
  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
  • IKF Pneumologie GmbH & Co. KG
  • Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
  • Lungenfachklinik Immenhausen
  • Klinikum Konstanz
  • KLB Gesundheitsforschung Lübeck GmbH
  • Klinikum der Universität München - Campus Innenstadt
  • Velocity Clinical Research Germany GmbH
  • Univ. Gen. Hosp. of Ioannina
  • Univ. Gen. Hosp. of Patras
  • Semmelweis University
  • Pulmonology Institute of Veszprem County, Farkasgyepu
  • Da Vinci Private Clinic
  • Soroka Univ. Medical Center
  • Lady Davis Carmel Medical Center
  • Hadassah Medical Center, Ein-Karem
  • Tel Aviv Sourasky Medical Center
  • A.O. Univ. Policlinico "Paolo Giaccone"
  • Fondazione IRCCS Policlinico S. Matteo
  • Istituto Clinico Humanitas
  • Nagoya University Hospital
  • Hirosaki University Hospital
  • Kameda Clinic
  • Kyushu University Hospital
  • Fukuoka University Hospital
  • Ibarakihigashi National Hospial
  • Kagoshima University Hospital
  • Kochi Medical School Hospital
  • Matsusaka City Hospital
  • Niigata University Medical and Dental Hospital
  • Osaka Toneyama Medical Center
  • Saga University Hospital
  • Tokyo Medical and Dental University Hospital
  • Fukujuji Hospital
  • Kitasato Institute Hospital
  • Chungbuk National University Hospital
  • Asan Medical Center
  • Korea University Guro Hospital
  • SMG-SNU Boramae Medical Center
  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
  • Daugavpils Regional Hospital LTD Centre Outpatient Clinic
  • Med.Center OLVI Health Center Assotiation,Private Practice
  • VCA Dubultu Medical center
  • Riga 1st Hospital
  • Pauls Stradins Clinical University Hospital
  • LUMPII Doctors practice
  • Mediadvance Clinical S.A.P.I de C.V.
  • Hospital Universitario Nuevo de Nuevo León - CEPREP
  • Accelerium S de RL de CV
  • Hospital Universitario Dr Jose Eleuterio Gonzalez
  • Oaxaca Site Management Organization, S.C.
  • Clinical Research Institute S.C.
  • Amsterdam UMC, Locatie AMC
  • Gelre Ziekenhuis Zutphen
  • Respiratory Medicine Centre, private prac., Bialystok
  • Screenmed Sp. z o.o.
  • Alergopneuma Medical Center
  • Altamed Specjalistyczna Praktyka Lekarska Pawel Siwinski
  • Dr. Piotr Napora, Center of Clinical Research
  • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria
  • Hospital Clínic de Barcelona
  • Hospital de Bellvitge
  • Hospital General Universitario Gregorio Marañón
  • Hospital de Mérida
  • Hospital Quirónsalud Madrid
  • Uludag Universitesi Tip Fakultesi
  • Marmara University Pendik Training and Research Hospital
  • Sureyyapasa Egitim ve Arastirma Hastanesi
  • Royal Papworth Hospital
  • Ninewells Hospital & Medical School
  • Liverpool Heart & Chest Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

BI 1291583: Low dose group

BI 1291583: Medium dose group

BI 1291583: High dose group

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Time to first pulmonary exacerbation up to 48 weeks after first drug administration

Secondary Outcome Measures

Key secondary: Rate of pulmonary exacerbations (number of events per person-time) up to week 48 after first drug administration
Absolute change from baseline in Quality of Life Questionnaire - Bronchiectasis (QOLB) respiratory symptoms domain score at week 24 after first drug administration
Relative change from baseline in neutrophil elastase (NE) activity in sputum at week 12 after first drug administration
Absolute change from baseline in St. George's Respiratory Questionnaire (SGRQ) Symptoms score at week 24 after first drug administration
Absolute change from baseline in percent predicted post-bronchodilator forced expiratory volume in one second (FEV1%pred) at week 24 after first drug administration
Occurrence of an exacerbation by week 24 after first drug administration

Full Information

First Posted
February 3, 2022
Last Updated
October 16, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT05238675
Brief Title
A Study to Test Whether Different Doses of BI 1291583 Help People With Bronchiectasis
Official Title
A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study Evaluating Efficacy, Safety and Tolerability of BI 1291583 qd Over at Least 24 Weeks in Patients With Bronchiectasis (AirleafTM)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
June 7, 2024 (Anticipated)
Study Completion Date
July 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is open to adults with bronchiectasis. People can join the study if they produce sputum and have a history of flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 4 groups randomly, which means by chance. Participants in groups 1, 2, and 3 get different doses of BI 1291583. Participants in group 4 get placebo. Placebo tablets look like BI 1291583 tablets, but do not contain any medicine. Participants take the tablets once a day. Participants are in the study for between 6 months and 1 year. During this time, they visit the study site about 10 times and get about 5 phone calls from the site staff. The doctors document when participants experience flare-ups during the study. The time to the first flare-ups is compared between the treatment groups. Doctors also regularly check participants' health and take note of any unwanted effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BI 1291583: Low dose group
Arm Type
Experimental
Arm Title
BI 1291583: Medium dose group
Arm Type
Experimental
Arm Title
BI 1291583: High dose group
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BI 1291583
Intervention Description
BI 1291583
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Time to first pulmonary exacerbation up to 48 weeks after first drug administration
Time Frame
Up to week 48
Secondary Outcome Measure Information:
Title
Key secondary: Rate of pulmonary exacerbations (number of events per person-time) up to week 48 after first drug administration
Time Frame
Up to week 48
Title
Absolute change from baseline in Quality of Life Questionnaire - Bronchiectasis (QOLB) respiratory symptoms domain score at week 24 after first drug administration
Time Frame
At baseline and at week 24
Title
Relative change from baseline in neutrophil elastase (NE) activity in sputum at week 12 after first drug administration
Time Frame
At baseline and at week 12
Title
Absolute change from baseline in St. George's Respiratory Questionnaire (SGRQ) Symptoms score at week 24 after first drug administration
Time Frame
At baseline and at week 24
Title
Absolute change from baseline in percent predicted post-bronchodilator forced expiratory volume in one second (FEV1%pred) at week 24 after first drug administration
Time Frame
At baseline and at week 24
Title
Occurrence of an exacerbation by week 24 after first drug administration
Time Frame
Up to week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Male or female patients: Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method. A list of contraception methods meeting these criteria is provided in the patient information. Men participating in this clinical trial must use male contraception (condom or sexual abstinence) if their sexual partner is a WOCBP. Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation. Age of patients when signing the informed consent ≥18 (for Korea: ≥19) and ≤85 years. Clinical history consistent with bronchiectasis (e.g., cough, chronic sputum production and/or recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by computed tomography (CT) scan. Subjects whose past chest radiographic image records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than 5 years. History of pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, patients must have had either: at least 2 exacerbations, or at least 1 exacerbation and a St. George´s Respiratory Questionnaire (SGRQ) Symptoms score of >40 at screening visit 1. For patients on stable oral or inhaled antibiotics as chronic treatment for bronchiectasis, at least one exacerbation must have occurred since initiation of stable antibiotics. - Current sputum producers with a history of chronic expectoration who are able to provide a spontaneous (not induced) sputum sample at Screening Visit 1. Exclusion Criteria: Laboratory and medical examination Aspartate Aminotransferase (AST) and / or Alanine Aminotransferase (ALT) >3.0 x upper limit of normal (ULN) at Visit 1, or moderate or severe liver disease (defined by Child-Pugh score B or C hepatic impairment). Estimated glomerular filtration rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula < 30 mL/min at Visit 1. An absolute blood neutrophil count <1,000/mm^3 at Visit 1 (equivalent to <1,000 cells/µL or <109 cells/L). Any findings in the medical examination and/or laboratory value assessed at Screening Visit 1 or during screening period, that in the opinion of the investigator may put the patient at risk by participating in the trial. Positive serological tests for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection, or known infection status. Concomitant diagnosis and therapy A current diagnosis of: Cystic Fibrosis Hypogammaglobulinemia Common variable immunodeficiency α1-antitrypsin deficiency being treated with augmentation therapy Allergic bronchopulmonary aspergillosis being treated or requiring treatment Tuberculosis or non-tuberculous mycobacterial infection being treated or requiring treatment according to local guidelines Palmoplantar keratosis; or keratoderma climactericum Hypothyroidism, myxedema, chronic lymphedema with associated hyperkeratosis of the skin, acrocyanosis. If a subject has hypothyroidism but is treated and compensated, the subject is allowed into the trial Psoriasis affecting palms and soles; or body surface area for psoriasis ≥ 10% Reactive arthritis (Reiter's syndrome); keratoderma blennorrhagicum Pityriasis rubra pilaris Atopic dermatitis affecting palms and soles; or body surface area for atopic dermatitis ≥ 10% Active extensive verruca vulgaris, as per investigator's discretion Active fungal infection of hand and/or feet not adequately treated, or not responsive to antifungal therapy, as per investigator's discretion. Any clinically relevant (at the discretion of the investigator) acute respiratory infection within 4 weeks prior Visit 2, or any other acute infection requiring systemic or inhaled anti-infective therapy within 4 weeks prior Visit 2. Any evidence of a concomitant disease, such as Papillon-Lefevre Syndrome, relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal disorders, or patients who are immunocompromised with a higher risk of invasive pneumococcal disease or other invasive opportunistic infections (such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis), that in the opinion of the investigator, may put the patient at risk by participating in the study. Received any live attenuated vaccine within 4 weeks prior to Visit 2. Medical conditions associated with periodontal disease (to be evaluated by a periodontist or dentist): Any tooth that can potentially cause pain or infection as noted in the oral exam unless they are corrected before the study (e.g. pulp necrosis). Severe periodontal disease defined as with pocket depth measurements ≥ 6 mm on 2 or more teeth. Class-3 mobility or Class-3 furcation involvement. Scheduled tooth extraction during the study period. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial. Further exclusion criteria apply
Facility Information:
Facility Name
Phoenix Medical Group
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Newport Native MD, Inc
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Central Florida Pulmonary Group
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Malcom Randall VA Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
University of Florida College of Medicine
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NewYork-Presbyterian/Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Southeastern Research Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Institute for Translational Oncology Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Metroplex Pulmonary & Sleep Center
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Diagnostics Research Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Texas Health Science Center at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Facility Name
Macquarie University
City
North Ryde
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Lung Research Queensland
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Mater Research Institute
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Institute for Respiratory Health
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Trialswest
City
Spearwood
State/Province
Western Australia
ZIP/Postal Code
6153
Country
Australia
Facility Name
AZ Sint-Jan Brugge
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
UNIV UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Medical Center "Zdrave-1"
City
Kozloduy
ZIP/Postal Code
3320
Country
Bulgaria
Facility Name
Medica Center Hera - Montana Branch
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Facility Name
Medical Center ReSpiro Ltd
City
Razgrad
ZIP/Postal Code
7200
Country
Bulgaria
Facility Name
SHATPFD "Dr. Dimitar Gramatikov"
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Medical Center Hera EOOD
City
Sofia
ZIP/Postal Code
1510
Country
Bulgaria
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Migration Data
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
IUCPQ (Laval University)
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Pulmonary Private Practice Kralupy
City
Kralupy nad Vltavou
ZIP/Postal Code
27801
Country
Czechia
Facility Name
The First Pulmonary Private Practice
City
Prague 9
ZIP/Postal Code
19000
Country
Czechia
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Copenhagen University Hospital, Rigshospitalet
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000 C
Country
Denmark
Facility Name
Sjællands Universitetshospital
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Vejle University Hospital
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Aalborg Sygehus Syd
City
Ålborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
HOP Amiens-Picardie Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
HOP Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
HOP Cochin
City
Paris
ZIP/Postal Code
75679
Country
France
Facility Name
HOP Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
HOP Perharidy
City
Roscoff
ZIP/Postal Code
29680
Country
France
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
City
Essen
ZIP/Postal Code
45239
Country
Germany
Facility Name
IKF Pneumologie GmbH & Co. KG
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Lungenfachklinik Immenhausen
City
Immenhausen
ZIP/Postal Code
34376
Country
Germany
Facility Name
Klinikum Konstanz
City
Konstanz
ZIP/Postal Code
78464
Country
Germany
Facility Name
KLB Gesundheitsforschung Lübeck GmbH
City
Lübeck
ZIP/Postal Code
23552
Country
Germany
Facility Name
Klinikum der Universität München - Campus Innenstadt
City
München
ZIP/Postal Code
80336
Country
Germany
Facility Name
Velocity Clinical Research Germany GmbH
City
Wiesbaden
ZIP/Postal Code
65189
Country
Germany
Facility Name
Univ. Gen. Hosp. of Ioannina
City
Ioannina
ZIP/Postal Code
45 500
Country
Greece
Facility Name
Univ. Gen. Hosp. of Patras
City
Patras
ZIP/Postal Code
26504
Country
Greece
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Pulmonology Institute of Veszprem County, Farkasgyepu
City
Farkasgyepu
ZIP/Postal Code
8582
Country
Hungary
Facility Name
Da Vinci Private Clinic
City
Pecs
ZIP/Postal Code
7635
Country
Hungary
Facility Name
Soroka Univ. Medical Center
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Lady Davis Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Hadassah Medical Center, Ein-Karem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6093246
Country
Israel
Facility Name
A.O. Univ. Policlinico "Paolo Giaccone"
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Fondazione IRCCS Policlinico S. Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano (MI)
ZIP/Postal Code
20089
Country
Italy
Facility Name
Nagoya University Hospital
City
Aichi, Nagoya
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Hirosaki University Hospital
City
Aomori, Hirosaki
ZIP/Postal Code
036-8563
Country
Japan
Facility Name
Kameda Clinic
City
Chiba, Kamogawa
ZIP/Postal Code
296-0041
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka, Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka, Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Ibarakihigashi National Hospial
City
Ibaraki, Naka-gun
ZIP/Postal Code
319-1113
Country
Japan
Facility Name
Kagoshima University Hospital
City
Kagoshima, Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
Kochi Medical School Hospital
City
Kochi, Nankoku
ZIP/Postal Code
783-8505
Country
Japan
Facility Name
Matsusaka City Hospital
City
Mie, Matsusaka
ZIP/Postal Code
515-8544
Country
Japan
Facility Name
Niigata University Medical and Dental Hospital
City
Niigata, Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Osaka Toneyama Medical Center
City
Osaka, Toyonaka
ZIP/Postal Code
560-8552
Country
Japan
Facility Name
Saga University Hospital
City
Saga, Saga
ZIP/Postal Code
849-8501
Country
Japan
Facility Name
Tokyo Medical and Dental University Hospital
City
Tokyo, Bunkyo-ku
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Fukujuji Hospital
City
Tokyo, Kiyose
ZIP/Postal Code
204-8522
Country
Japan
Facility Name
Kitasato Institute Hospital
City
Tokyo, Minato-ku
ZIP/Postal Code
108-8642
Country
Japan
Facility Name
Chungbuk National University Hospital
City
Cheongju
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
City
Seoul
ZIP/Postal Code
22711
Country
Korea, Republic of
Facility Name
Daugavpils Regional Hospital LTD Centre Outpatient Clinic
City
Daugavpils
ZIP/Postal Code
5401
Country
Latvia
Facility Name
Med.Center OLVI Health Center Assotiation,Private Practice
City
Daugavpils
ZIP/Postal Code
5410
Country
Latvia
Facility Name
VCA Dubultu Medical center
City
Jurmala
ZIP/Postal Code
2015
Country
Latvia
Facility Name
Riga 1st Hospital
City
Riga
ZIP/Postal Code
1001
Country
Latvia
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
LUMPII Doctors practice
City
Riga
ZIP/Postal Code
1011
Country
Latvia
Facility Name
Mediadvance Clinical S.A.P.I de C.V.
City
Chihuahua
ZIP/Postal Code
31210
Country
Mexico
Facility Name
Hospital Universitario Nuevo de Nuevo León - CEPREP
City
Monterrey, Nuevo León
ZIP/Postal Code
C.P. 64460
Country
Mexico
Facility Name
Accelerium S de RL de CV
City
Monterrey
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Hospital Universitario Dr Jose Eleuterio Gonzalez
City
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Oaxaca Site Management Organization, S.C.
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Clinical Research Institute S.C.
City
Tlalnepantla
ZIP/Postal Code
54055
Country
Mexico
Facility Name
Amsterdam UMC, Locatie AMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Gelre Ziekenhuis Zutphen
City
Zutphen
ZIP/Postal Code
7207 AE
Country
Netherlands
Facility Name
Respiratory Medicine Centre, private prac., Bialystok
City
Bialystok
ZIP/Postal Code
15044
Country
Poland
Facility Name
Screenmed Sp. z o.o.
City
Piaseczno
ZIP/Postal Code
05500
Country
Poland
Facility Name
Alergopneuma Medical Center
City
Swidnik
ZIP/Postal Code
21040
Country
Poland
Facility Name
Altamed Specjalistyczna Praktyka Lekarska Pawel Siwinski
City
Warszawa
ZIP/Postal Code
01-456
Country
Poland
Facility Name
Dr. Piotr Napora, Center of Clinical Research
City
Wroclaw
ZIP/Postal Code
51162
Country
Poland
Facility Name
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria
City
Lisboa
ZIP/Postal Code
1064-035
Country
Portugal
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de Bellvitge
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital de Mérida
City
Mérida
ZIP/Postal Code
06800
Country
Spain
Facility Name
Hospital Quirónsalud Madrid
City
Pozuelo de Alarcón
ZIP/Postal Code
28223
Country
Spain
Facility Name
Uludag Universitesi Tip Fakultesi
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Marmara University Pendik Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Facility Name
Sureyyapasa Egitim ve Arastirma Hastanesi
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Facility Name
Royal Papworth Hospital
City
Cambridge
ZIP/Postal Code
CB2 0AY
Country
United Kingdom
Facility Name
Ninewells Hospital & Medical School
City
Dundee, Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Liverpool Heart & Chest Hospital
City
Liverpool
ZIP/Postal Code
L14 3PE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringeringelheim.com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
IPD Sharing Time Frame
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD Sharing Access Criteria
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
http://www.mystudywindow.com
Description
Related Info

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