Tezepelumab for Asthma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Research Site, Chmielnik, PolandAsthmaTezepelumab - Biological
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether Tezepelumab can help reduce oral steroid use in people with severe asthma, who are already taking them with or without other asthma medications.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 13 Secondary · Reporting Duration: At Week 52

At Week 52
Proportion of participants who discontinued OCS without loss of asthma control
Proportion of participants who reduced daily prescribed maintenance OCS dose to ≤ 5 mg/day without loss of asthma control
Baseline to Week 52
Absolute and percent change from baseline in daily maintenance OCS dose
Categorised percent reduction from baseline in the daily maintenance OCS dose
Change from baseline in Asthma Control Questionnaire 6 (ACQ-6) score
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score
Change from baseline in post-bronchodilator (post-BD) FEV1
Change from baseline in standardised Asthma Quality of Life Questionnaire for 12 years and older (AQLQ[s]+12) total score
Proportion of participants who did not experience an exacerbation
Proportion of participants who did not experience an exacerbation associated with hospitalisation
Proportion of participants who did not experience an exacerbation associated with hospitalisation or ER visit
Proportion of participants with ≥ 50% reduction from baseline in daily maintenance OCS dose
Rate of asthma exacerbation associated with hospitalisation
Rate of asthma exacerbation associated with hospitalisation or emergency room (ER)
The Annualised Asthma Exacerbation Rate

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Tezepelumab
16%Nasopharyngitis
12%Upper respiratory tract infection
8%Bronchitis bacterial
8%Asthma
5%Bronchitis
5%Oral candidiasis
5%Myalgia
4%Fall
4%Headache
3%Hypertension
1%Cataract
1%Cardiac arrest
1%Cardiac failure
1%Supraventricular tachycardia
1%Inguinal hernia
1%Intervertebral discitis
1%Pneumonia
1%Septic shock
1%Incisional hernia
1%Arthralgia
1%Invasive breast carcinoma
1%Acute kidney injury
1%Nephrolithiasis
1%Sinusitis
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT03406078) in the Tezepelumab ARM group. Side effects include: Nasopharyngitis with 16%, Upper respiratory tract infection with 12%, Bronchitis bacterial with 8%, Asthma with 8%, Bronchitis with 5%.

Trial Design

1 Treatment Group

Tezepelumab
1 of 1

Experimental Treatment

300 Total Participants · 1 Treatment Group

Primary Treatment: Tezepelumab · No Placebo Group · Phase 3

Tezepelumab
Biological
Experimental Group · 1 Intervention: Tezepelumab · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tezepelumab
2018
Completed Phase 3
~1780

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at week 52

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,021 Previous Clinical Trials
240,381,154 Total Patients Enrolled
312 Trials studying Asthma
618,092 Patients Enrolled for Asthma

Eligibility Criteria

Age 18 - 80 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had a severe asthma attack within the last year before starting the study.
There are additional requirements for participation in the study, as outlined in the study protocol.

Who else is applying?

What state do they live in?
New York50.0%
California50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Research Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Typically responds via
Phone Call100.0%
Most responsive sites:
  1. Research Site: < 48 hours
Average response time
  • < 2 Days

Frequently Asked Questions

How many people are participating in this trial at any given time?

"Yes, as the listing on clinicaltrials.gov indicates, this study is recruiting patients. The trial was originally posted on May 17th, 2022 and has been edited most recently on November 4th of the same year. Currently, 8 different locations are looking for a total of 323 participants." - Anonymous Online Contributor

Unverified Answer

Are there any participants needed for this clinical trial at the moment?

"Yes, the information on clinicaltrials.gov suggests that this study is recruiting patients as of the most recent update on 11/4/2022. The trial was first posted 5/17/2022 and is enrolling 323 participants between 8 locations." - Anonymous Online Contributor

Unverified Answer

Who meets the requirements to be a test subject in this experiment?

"This trial is recruiting 323 participants who have asthma and are between the ages of 18 and 80. The following criteria must be met in order to be eligible for the study: - Age 18-80 years- Documented long-term OCS therapy for asthma, equivalent to a daily dose of at least 5 mg and up to 40 mg of prednisone/prednisolone for at least 3 continuous months directly preceding Visit 1- Participant should be on a stable OCS dose for at least 4 weeks prior to Visit 1- Documented history of at least 1 asthma exacerbation event within 12 months prior" - Anonymous Online Contributor

Unverified Answer

Could you please elaborate on the potential risks of Tezepelumab?

"Tezepelumab is a medication that has completed Phase 3 clinical trials. This means there is available data which supports its efficacy and multiple rounds of data supporting safety. Our team at Power estimates the safety of Tezepelumab to be a 3 on a scale from 1 to 3." - Anonymous Online Contributor

Unverified Answer

Is this clinical trial happening at more than one hospital in the state?

"Currently, this trial is running at 8 sites. They are situated in Ann Arbor, Riverdale and Newark as well as 5 other locations. If you want to participate, it would be advantageous to choose the location nearest to you so that travelling isn't an inconvenience." - Anonymous Online Contributor

Unverified Answer

For this particular test, is the age limit set at 45 years or above?

"Enrolment for this study is open to patients aged between 18-80 years old. There are 117 clinical trials available for minors and 202 for senior citizens." - Anonymous Online Contributor

Unverified Answer

What goals does this research hope to achieve?

"The primary outcome that will be assessed at Week 52 is the percentage of patients who are able to reduce their daily maintenance oral corticosteroid dose to 5 mg/day or below without loss of asthma control. Additionally, researchers will also monitor the rate of hospitalization and emergency room visits due to exacerbations, as well as the overall number of exacerbations over the course of the trial." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.