Tezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA)

ConditionSevere Asthma
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUniversity of Alberta

About this trial

Adults with severe asthma may have sudden worsening shortness of breath that results in their going to Emergency Department for urgent care. Emergency Room visits for asthma management across Alberta have been reviewed and it has been found that adults frequently need to return for repeated worsening. This is a large drain on health care resources as well as being very distressing for individuals with asthma. Occasionally this results in admission to hospital and rarely may lead to death. People are often treated with steroids to try to prevent the need for Emergency Room visits even though steroid medications have many long term bad side effects.

A new medication for patients considered to have severe asthma has been recently approved by Health Canada. This medication, Tezepelumab, is a monthly injection and it helps control asthma in adults regardless of the underlying cause. The study will examine if starting Tezepelumab, compared with a placebo, in the Emergency Room will help settle symptoms of asthma and prevent future worsening requiring repeated Emergency Room visits or the need for courses of outpatient steroid medications.

Eligibility criteria

Qualifiers

Provision of informed consent prior to any study specific procedures

Female and/or male aged 18 to 55 years

History of physician-diagnosed asthma

All subjects will have been prescribed high dose inhaled corticosteroid (> 500 ug fluticasone propionate dry powder formulation equivalents total daily dose. See Appendix C) plus at least one second controller (LABA, LAMA or LTRA) for at least 3 months prior to enrolment.

Disqualifiers

Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)

Previous enrolment in the present study

Participation in another clinical study with an investigational product during the last 6 months

Patients with a known hypersensitivity to Tezepelumab or any of the excipients of the product.

Trial design

Treatments tested in this trial

  • Tezepelumab
  • Placebo

Treatment groups

100 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University of Alberta

Lead sponsor

AstraZeneca

Collaborator