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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05238675




Registration number
NCT05238675
Ethics application status
Date submitted
3/02/2022
Date registered
14/02/2022

Titles & IDs
Public title
A Study to Test Whether Different Doses of BI 1291583 Help People With Bronchiectasis
Scientific 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)
Secondary ID [1] 0 0
2021-003304-41
Secondary ID [2] 0 0
1397-0012
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BI 1291583
Treatment: Drugs - Placebo

Experimental: BI 1291583: Low dose group -

Experimental: BI 1291583: Medium dose group -

Experimental: BI 1291583: High dose group -

Placebo comparator: Placebo -


Treatment: Drugs: BI 1291583
BI 1291583

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first pulmonary exacerbation up to 48 weeks after first drug administration
Timepoint [1] 0 0
Up to week 48
Secondary outcome [1] 0 0
Key secondary: Rate of pulmonary exacerbations (number of events per person-time) up to week 48 after first drug administration
Timepoint [1] 0 0
Up to week 48
Secondary outcome [2] 0 0
Absolute change from baseline in Quality of Life Questionnaire - Bronchiectasis (QOLB) respiratory symptoms domain score at week 24 after first drug administration
Timepoint [2] 0 0
At baseline and at week 24
Secondary outcome [3] 0 0
Relative change from baseline in neutrophil elastase (NE) activity in sputum at week 12 after first drug administration
Timepoint [3] 0 0
At baseline and at week 12
Secondary outcome [4] 0 0
Absolute change from baseline in St. George's Respiratory Questionnaire (SGRQ) Symptoms score at week 24 after first drug administration
Timepoint [4] 0 0
At baseline and at week 24
Secondary outcome [5] 0 0
Absolute change from baseline in percent predicted post-bronchodilator forced expiratory volume in one second (FEV1%pred) at week 24 after first drug administration
Timepoint [5] 0 0
At baseline and at week 24
Secondary outcome [6] 0 0
Occurrence of an exacerbation by week 24 after first drug administration
Timepoint [6] 0 0
Up to week 24

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
* a1-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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/05/2024
Sample size
Target
Accrual to date
Final
322
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Macquarie University - North Ryde
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Lung Research Queensland - Chermside
Recruitment hospital [4] 0 0
Mater Research Institute - South Brisbane
Recruitment hospital [5] 0 0
Institute for Respiratory Health - Nedlands
Recruitment hospital [6] 0 0
Trialswest - Spearwood
Recruitment postcode(s) [1] 0 0
2109 - North Ryde
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
6153 - Spearwood
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Belgium
State/province [10] 0 0
Gent
Country [11] 0 0
Belgium
State/province [11] 0 0
Leuven
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Kozloduy
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Montana
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Razgrad
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Ruse
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Sofia
Country [17] 0 0
Canada
State/province [17] 0 0
Migration Data
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Czechia
State/province [19] 0 0
Kralupy nad Vltavou
Country [20] 0 0
Czechia
State/province [20] 0 0
Prague 9
Country [21] 0 0
Denmark
State/province [21] 0 0
Hvidovre
Country [22] 0 0
Denmark
State/province [22] 0 0
København Ø
Country [23] 0 0
Denmark
State/province [23] 0 0
Odense
Country [24] 0 0
Denmark
State/province [24] 0 0
Roskilde
Country [25] 0 0
Denmark
State/province [25] 0 0
Vejle
Country [26] 0 0
Denmark
State/province [26] 0 0
Ålborg
Country [27] 0 0
France
State/province [27] 0 0
Amiens
Country [28] 0 0
France
State/province [28] 0 0
Montpellier
Country [29] 0 0
France
State/province [29] 0 0
Paris
Country [30] 0 0
France
State/province [30] 0 0
Rennes
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Germany
State/province [32] 0 0
Essen
Country [33] 0 0
Germany
State/province [33] 0 0
Frankfurt
Country [34] 0 0
Germany
State/province [34] 0 0
Großhansdorf
Country [35] 0 0
Germany
State/province [35] 0 0
Immenhausen
Country [36] 0 0
Germany
State/province [36] 0 0
Konstanz
Country [37] 0 0
Germany
State/province [37] 0 0
Lübeck
Country [38] 0 0
Germany
State/province [38] 0 0
München
Country [39] 0 0
Germany
State/province [39] 0 0
Wiesbaden
Country [40] 0 0
Greece
State/province [40] 0 0
Ioannina
Country [41] 0 0
Hungary
State/province [41] 0 0
Budapest
Country [42] 0 0
Hungary
State/province [42] 0 0
Pecs
Country [43] 0 0
Israel
State/province [43] 0 0
Beer Sheva
Country [44] 0 0
Israel
State/province [44] 0 0
Haifa
Country [45] 0 0
Israel
State/province [45] 0 0
Jerusalem
Country [46] 0 0
Israel
State/province [46] 0 0
Tel Aviv
Country [47] 0 0
Italy
State/province [47] 0 0
Palermo
Country [48] 0 0
Italy
State/province [48] 0 0
Pavia
Country [49] 0 0
Italy
State/province [49] 0 0
Rozzano (MI)
Country [50] 0 0
Japan
State/province [50] 0 0
Aichi, Nagoya
Country [51] 0 0
Japan
State/province [51] 0 0
Aomori, Hirosaki
Country [52] 0 0
Japan
State/province [52] 0 0
Chiba, Kamogawa
Country [53] 0 0
Japan
State/province [53] 0 0
Fukuoka, Fukuoka
Country [54] 0 0
Japan
State/province [54] 0 0
Ibaraki, Naka-gun
Country [55] 0 0
Japan
State/province [55] 0 0
Kagoshima, Kagoshima
Country [56] 0 0
Japan
State/province [56] 0 0
Mie, Matsusaka
Country [57] 0 0
Japan
State/province [57] 0 0
Niigata, Niigata
Country [58] 0 0
Japan
State/province [58] 0 0
Osaka, Toyonaka
Country [59] 0 0
Japan
State/province [59] 0 0
Saga, Saga
Country [60] 0 0
Japan
State/province [60] 0 0
Tokyo, Kiyose
Country [61] 0 0
Japan
State/province [61] 0 0
Tokyo, Minato-ku
Country [62] 0 0
Korea, Republic of
State/province [62] 0 0
Cheongju
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Seoul
Country [64] 0 0
Latvia
State/province [64] 0 0
Daugavpils
Country [65] 0 0
Latvia
State/province [65] 0 0
Jurmala
Country [66] 0 0
Latvia
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Riga
Country [67] 0 0
Mexico
State/province [67] 0 0
Chihuahua
Country [68] 0 0
Mexico
State/province [68] 0 0
Monterrey, Nuevo León
Country [69] 0 0
Mexico
State/province [69] 0 0
Monterrey
Country [70] 0 0
Mexico
State/province [70] 0 0
Nuevo Leon
Country [71] 0 0
Mexico
State/province [71] 0 0
Oaxaca
Country [72] 0 0
Mexico
State/province [72] 0 0
Tlalnepantla
Country [73] 0 0
Netherlands
State/province [73] 0 0
Amsterdam
Country [74] 0 0
Netherlands
State/province [74] 0 0
Zutphen
Country [75] 0 0
Poland
State/province [75] 0 0
Bialystok
Country [76] 0 0
Poland
State/province [76] 0 0
Piaseczno
Country [77] 0 0
Poland
State/province [77] 0 0
Swidnik
Country [78] 0 0
Poland
State/province [78] 0 0
Warszawa
Country [79] 0 0
Poland
State/province [79] 0 0
Wroclaw
Country [80] 0 0
Portugal
State/province [80] 0 0
Lisboa
Country [81] 0 0
Spain
State/province [81] 0 0
Barcelona
Country [82] 0 0
Spain
State/province [82] 0 0
L'Hospitalet de Llobregat
Country [83] 0 0
Spain
State/province [83] 0 0
Madrid
Country [84] 0 0
Spain
State/province [84] 0 0
Mérida
Country [85] 0 0
Spain
State/province [85] 0 0
Pozuelo de Alarcón
Country [86] 0 0
Turkey
State/province [86] 0 0
Bursa
Country [87] 0 0
Turkey
State/province [87] 0 0
Istanbul
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Cambridge
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Dundee, Scotland
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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'.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05238675