A study to test whether different doses of BI 1291583 help people with bronchiectasis

Phase 1

• Conditions: bronchiectasis; MedDRA version: 21.0Level: PTClassification code 10006445Term: BronchiectasisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2021-003304-41-ES
• Lead Sponsor: Boehringer Ingelheim España S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-20
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

- Male or female (not of childbearing potential) patients
- Age of patients when signing the informed consent =18 and =85 years.
- Clinical history consistent with bronchiectasis (cough, chronic sputum production and/or recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by computed tomography (CT) scan.
- 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 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

Exclusion Criteria

- AST and / or ALT >3.0 x ULN at Visit 1
- Estimated glomerular filtration rate (eGFR) according to CKD-EPI formula < 30 mL/min at Visit 1.
- An absolute blood neutrophil count <1,000/mm3 at Visit 1.
- Any clinically relevant finding in the medical examination (including BP, PR, or ECG) and/or laboratory value assessed by the Investigator at Screening Visit 1 or during screening period.
- Positive serological tests for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection, or known infection status.
- A current diagnosis of
-- Cystic Fibrosis
-- Hypogammaglobulinemia
-- Common variable immunodeficiency
-- a1-antitrypsin deficiency
-- Allergic bronchopulmonary aspergillosis 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 and responsive to antifungal therapy, as per investigator’s discretion
- Any acute infections (including respiratory infections) defined as infections requiring systemic or inhaled antibiotic 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, or hormonal disorders.
- 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).
- 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 criteria apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified