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Clinical Trials/EUCTR2021-003304-41-PL
EUCTR2021-003304-41-PL
Active, not recruiting
Phase 1

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 (Airleaf™) - CatC inhibitor Phase II in bronchiectasis

Boehringer Ingelheim RCV GmbH & Co KG0 sites240 target enrollmentFebruary 21, 2022
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ConditionsbronchiectasisMedDRA version: 21.0Level: PTClassification code 10006445Term: BronchiectasisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
bronchiectasis
Sponsor
Boehringer Ingelheim RCV GmbH & Co KG
Enrollment
240
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 21, 2022
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Male or female 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:

Exclusion Criteria

  • •1\) AST and / or ALT \>3\.0 x ULN at Visit 1, or moderate or severe liver disease (defined by Child\-Pugh score B or C hepatic impairment).
  • •2\) Estimated glomerular filtration rate (eGFR) according to CKD\-EPI formula \< 30 mL/min at Visit 1\.
  • •3\) An absolute blood neutrophil count \<1,000/mm3 at Visit 1\.
  • •4\) 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.
  • •5\) Positive serological tests for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection, or known infection status.
  • •6\) A current diagnosis of
  • •\-\- Cystic Fibrosis
  • •\-\- Hypogammaglobulinemia
  • •\-\- Common variable immunodeficiency
  • •\-\- a1\-antitrypsin deficiency treated with augmentation therapy

Outcomes

Primary Outcomes

Not specified

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