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Monoclonal Antibodies
Tezepelumab for COPD (COURSE Trial)
Phase 2
Waitlist Available
Led By Dave Singh, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0, 4, 12, 24, 36, 52, 64
Awards & highlights
COURSE Trial Summary
This trial is testing the effect of tezepelumab on COPD and its safety.
Who is the study for?
Adults with moderate to very severe COPD, who've had at least two flare-ups in the past year and have been on stable triple therapy for the same duration. They should not have other significant lung conditions or unstable health issues, be pregnant or breastfeeding, or have had recent infections or major surgery.Check my eligibility
What is being tested?
The study is testing Tezepelumab's effectiveness and safety against a placebo in reducing COPD exacerbations. Participants are randomly assigned to receive either Tezepelumab or a placebo without knowing which one they're getting (double-blind).See study design
What are the potential side effects?
Potential side effects of Tezepelumab may include reactions at the injection site, headaches, fatigue, and possibly an increased risk of respiratory infections. The exact side effects will be monitored throughout the trial.
COURSE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 0, 4, 12, 24, 36, 52, 64
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0, 4, 12, 24, 36, 52, 64
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Moderate or severe COPD exacerbation rate ratio (tezepelumab vs placebo)
Secondary outcome measures
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score
Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)
Change from baseline in the COPD Assessment Test (CAT) Total Score
+6 moreCOURSE Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: TezepelumabActive Control1 Intervention
Tezepelumab, SC, Q4W
Group II: Matching PlaceboPlacebo Group1 Intervention
Matching placebo, SC, Q4W
Find a Location
Who is running the clinical trial?
AmgenIndustry Sponsor
1,370 Previous Clinical Trials
1,377,351 Total Patients Enrolled
AstraZenecaLead Sponsor
4,259 Previous Clinical Trials
288,593,565 Total Patients Enrolled
Dave Singh, MDPrincipal InvestigatorDivision of Infection, Immunity & Resp Medicine, The University of Manchester, United Kingdom
18 Previous Clinical Trials
2,401 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your CAT score is 15 or higher when you join the study and on the day you are randomly chosen for a group.You have been diagnosed with moderate to very severe COPD for at least a year, and specific lung function test results fall within certain ranges.You currently have COVID-19.Your CAT score is 15 or higher when you join the study and on the randomization day.You have a lung condition that would make it hard for you to finish the study.You have had at least two serious COPD flare-ups in the past year.You have had at least 2 serious COPD flare-ups in the past year.You have a significant lung disease besides COPD, as determined by the doctor (including current or past asthma).You have any ongoing health problems that are not under control.You have been consistently using a specific type of medication for COPD called triple therapy for the past year, and the dose has been the same for the past three months.You have been consistently taking a specific combination of medications for COPD for the past year, and the dose of one of the medications has stayed the same for the past 3 months.You have been diagnosed with a certain type of lung disease for at least a year, and specific lung function test results show breathing difficulties.
Research Study Groups:
This trial has the following groups:- Group 1: Matching Placebo
- Group 2: Tezepelumab
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Obstructive Pulmonary Disease Patient Testimony for trial: Trial Name: NCT04039113 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Tezepelumab completed the necessary trials for public consumption?
"Tezepelumab, which is currently in Phase 2 clinical trials, has some safety data but its efficacy has not yet been studied."
Answered by AI
Which patients are eligible to take part in this clinical trial?
"This clinical trial is looking for 338 patients between the ages of 40 and 80 who have lung diseases, obstructive. The following criteria must also be met: History of moderate to very severe physician-diagnosed COPD for at least 12 months prior to enrolment with a post-bronchodilator FEV1/FVC<0.70 and a post-bronchodilator FEV1 ≥20% and ≤80% of predicted normal value., History of at least 2 documented moderate to severe COPD exacerbations within 2 to 52 weeks prior to enrollment., CAT score of ≥15 at enrollment"
Answered by AI
Are patients over the age of 35 eligible for this clinical trial?
"This trial's age requirements are that participants must be at least 40 years old but no older than 80."
Answered by AI
Have there been other similar clinical trials like this one in the past?
"Amgen first sponsored a clinical trial for Tezepelumab in 2019. The Phase 3 approval followed this initial 396-person study. There are 4 active trials for Tezepelumab currently underway in 127 cities and 17 countries."
Answered by AI
Are there other ongoing studies that also use Tezepelumab?
"Tezepelumab was first trialled in 2019. Out of the 18250 completed trials, 4 are still ongoing, with 2 in Quebec and 2 in California."
Answered by AI
How many different hospitals are handling this research?
"To lessen the burden of travel for potential participants, this study is enrolling patients at 27 sites. These locations include Quebec, Riverside and Philadelphia, among other places."
Answered by AI
Who else is applying?
What state do they live in?
California
Pennsylvania
Florida
How old are they?
65+
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+
Why did patients apply to this trial?
looking for something more effective. I have been diagnosed with hypoxemic respiritory failure and cannot find anyone who can help me. Any suggestions?
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Who can treat me?
PatientReceived no prior treatments
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