Efficacy and safety of BI 655066 in patients with severe persistent asthma.
- Conditions
- Severe AsthmaTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2014-004932-20-HU
- Lead Sponsor
- Boehringer Ingelheim RCV GmbH & CoKG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
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: 0
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
1. Patients with a significant disease other than asthma.
2. Patients who are not able to produce sputum or sputum samples of sufficient quality.
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
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of this trial is to evaluate the efficacy and safety of BI 655066 as compared to placebo in severe asthma patients.;Secondary Objective: To identify a diagnostic biomarker that can be used to identify patients who will likely respond to therapy with BI 655066.;Primary end point(s): Time to first asthma worsening during the planned 24 week treatment period<br>;Timepoint(s) of evaluation of this end point: 24 weeks<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1: Annualized rate of asthma worsening during the planned 24 week treatment period<br>2: Annualized rate of severe asthma exacerbation during the planned 24-week treatment period<br>3: Weekly Asthma Control Questionaire score at week 24<br>4: Trough FEV1 in-clinic change from baseline at week 24<br>5: Post-bronchodilator FEV1 in-clinic change from baseline at week 24<br>6: Time to first severe asthma exacerbation during the planned 24-week treatment period<br>;Timepoint(s) of evaluation of this end point: 1: 24 weeks<br><br>2: 24 weeks<br><br>3: 24 weeks<br><br>4: 24 weeks<br><br>5: 24 weeks<br><br>6: 24 weeks<br>