EUCTR2014-004932-20-IT
Active, not recruiting
Phase 1
A phase IIa, randomized, double-blind, placebo controlled, parallel group study to assess the safety and efficacy of subcutaneously administered BI 655066 as add-on therapy over 24 weeks in patients with severe persistent asthma - Efficacy and safety of BI 655066 in patients with severe persistent asthma
BOEHRINGER-INGELHEIM ITALIA S.P.A.0 sites369 target enrollmentStarted: May 27, 2021Last updated:
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- BOEHRINGER-INGELHEIM ITALIA S.P.A.
- Enrollment
- 369
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1\. Pre\-bronchodilator clinic measured FEV1 between 40% and 85% of
- •predicted normal.
- •2\. One year history of asthma diagnosed by a physician, and have FEV1
- •reversibility of 12% and an absolute change of at least 200 mL after
- •administration of 400 µg salbutamol.
- •3\. Must be on at least medium dose inhaled corticosteroids and at least
- •one other asthma controller medication for at least one year.
- •4\. Must have documented history of two or more severe asthma
- •exacerbations in the last 12 months
- •Are the trial subjects under 18? no
Exclusion Criteria
- •1\. Patients with a significant disease other than asthma.
- •2\. Patients who are not able to produce sputum or sputum samples of
- •sufficient quality.
- •XML File Identifier: /Ag9\+kUs6gIYLIK85mAFwCKYo9w\=
- •3\. Patients who had clinically relevant history of intubation for asthma
- •exacerbation in the past year.
- •4\. Patients diagnosed with any concurrent respiratory disease.
- •5\. Recent history (within 6 months) of myocardial infarction or
- •hospitalized for cardiac failure in the past year.
- •6\. Patients who have undergone thoracotomy with pulmonary resection.
Investigators
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