NCT02443298

Efficacy and Safety of an Active Drug in Patients With Severe Persistent Asthma

Brief summary

The objectives of this trial are primarily to evaluate the efficacy and safety of an active drug as compared to placebo over a 24-week treatment period in severe asthma patients. The primary endpoint is time to first asthma worsening during the planned 24 week treatment period for active vs. placebo treated patients on top of standard of care therapy. Upon demonstration of a meaningful clinical response, another important objective is the identification of biomarkers that can be used to target patients who will likely respond to treatment with an active drug.

Interventional study

Status:
Completed
Conditions:
Asthma
Enrollment:
214 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
1311
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 75 Years.

Inclusion criteria:

1. Pre-bronchodilator clinic measured forced expiratory volume (FEV1) of =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.

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.

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.

All the cities where the clinical studies are located

Vancouver - V5Z 1M9
Burlington - L7N 3V2
Hamilton - L8N 4A6

British Columbia