Health TrialsbyHealthPanel

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

ConditionSevere Asthma
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Tezepelumab

    Drug

    Tezepelumab 210 mg (1.91 ml) subcutaneous every 4 weeks. Randomized Control Trial 90 days with Tezepelumab/ Matching Placebo dosing on Day 0, Day 30 and Day 60. Open-label extension study from Day 90 to Day 180 with Tezepelumab dosing at Day 90

  • Placebo

    Drug

    Placebo 1.91 ml subcutaneous every 4 weeks. Randomized Control Trial 90 days with Tezepelumab/ Matching Placebo dosing on Day 0, Day 30 and Day 60.

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: TezepelumabActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: Tezepelumab Open LabelOther 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients who have moderate and severe exacerbations of asthma

Numbers of moderate and severe exacerbations at Day 90 post-treatment in subjects treated with standard care and S/Q Tezepelumab or treated with standard care and placebo

Time frame
90 Days post-treatment

Secondary outcomes

1

Numbers of subjects returning to ED

Numbers of subjects returning to ED by Day-90 in those treated with standard care and S/Q Tezepelumab or treated with standard care and placebo.

Time frame
90 Days post-treatment
2

Proportion of subjects returning to ED

Proportion of subjects returning to ED by Day-30 and Day-60 in those treated with standard care and S/Q Tezepelumab or treated with standard care and placebo.

Time frame
60 Days post-treatment
3

Asthma control Questionnaire (ACQ-5)

ACQ-5 at Day-90 in subjects treated with standard care and S/Q Tezepelumab or treated with standard care and placebo ACQ-5 greater than 1.5 units in subjects treated with standard care and S/Q Tezepelumab or treated with standard care and placebo ACQ-5 less than 0.75 units in subjects treated with standard care and S/Q Tezepelumab or treated with standard care and placebo ACQ (Asthma Control Questionnaire). Each question is scored on a scale of 0 to 6, with 0 representing excellent control and 6 representing extremely poor control. The final score is the mean of the five responses.

Time frame
90 Days post-treatment
4

TSLP levels

TSLP levels at the time of ED presentation

Time frame
Day 1

Other outcomes

1

Number of participants with treatment-related adverse events as assessed by an intensity rating scale

To evaluate the safety and tolerability of Tezepelumab in relation to Placebo the results from laboratory tests and vital signs will be assessed to determine treatment-related adverse events.

Time frame
Through study completion, an average of 180 days
2

Nasal brushing expressions of TSLP(Exploratory Outcome)

Nasal brushing expressions of TSLP

Time frame
Day-30, 90 and 180 post ED visit
3

Measure ACQ-5 at selected time-points (Exploratory Outcome)

Compare time course of ACQ-5 following discharge from ED in subjects treated with standard care and S/Q Tezepelumab or treated with standard care and placebo at Day-30, 90 and 180 post ED visit. 1. Compare frequency of uncontrolled subjects (ACQ-5 greater than 1.5 units) in subjects treated with standard care and S/Q Tezepelumab or treated with standard care and placebo at Day-30 and 180. 2. Compare frequency of well-controlled subjects (ACQ-5 less than 0.75 units) in subjects treated with standard care and S/Q Tezepelumab or treated with standard care and placebo at Day-30 and 180. ACQ (Asthma Control Questionnaire). Each question is scored on a scale of 0 to 6, with 0 representing excellent control and 6 representing extremely poor control. The final score is the mean of the five responses.

Time frame
Day-30, 90 and 180 post ED visit
4

Measure pre-bronchodilator FEV1 at selected time points (exploratory outcome)

Compare time course of lung function, assessed as in-laboratory FEV1, following discharge from ED in subjects treated with standard care and S/Q Tezepelumab or treated with standard care and placebo at 30, 90 and 180 days post ED visit.

Time frame
Day 30, 90 and 180 days post ED visit

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

AstraZeneca

Collaborator

Source ClinicalTrials.gov
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