Efficacy and safety of BI 655066 in patients with severe persistent asthma

Phase 1

• Conditions: Severe Asthma; MedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-004932-20-IT
• Lead Sponsor: BOEHRINGER-INGELHEIM ITALIA S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-02-02
• Study Start: 2021-05-27
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 369

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
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 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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.
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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.
7. Patients who have undergone bronchial thermoplasty or radiotherapy
procedure in the past year or have planned procedures during the study.
8. Patients taking oral corticosteroids with a total daily dose of more
than 20 mg prednisone (or equivalent) in the past 6 weeks.
9. Pregnant or nursing women.
10. Women of childbearing potential that, if sexually active, is unwilling
to use a highly effective method of birth control.
11. Clinically relevant acute infections or chronic infections.
12. Have received any live bacterial or live viral vaccination in the last12
weeks.
13. Have received Bacille Calmette-Guerin (BCG) vaccination in the last
12 months.
14. Have received treatment with ustekinumab (Stelara®).
15. Have received treatment with any other biologics in the last 3
months or within 6 times the half-life of the compound

Study & Design

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