RecruitingPHASE3INTERVENTIONAL

A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006)

This study is looking into a new medicine called tezepelumab for adults living with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). The main goal is to find out if this medicine can help improve symptoms and reduce flare-ups of COPD, and if it's safe. Some people will receive the new medicine, while others will get a placebo (a dummy medicine) in a carefully controlled way. This helps researchers understand the true effects of tezepelumab. This research is in its final stages of testing, known as Phase 3, and involves many different hospitals and clinics to gather enough information.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

990

Start

18 Mar 2025

Estimated completion

05 Jun 2029

Chronic Obstructive Pulmonary Disease (COPD)

What is this study about?

This research study is focused on people who have moderate to very severe Chronic Obstructive Pulmonary Disease, often known as COPD. COPD makes it hard to breathe because of damage to the lungs, and it can significantly affect daily life. Researchers are investigating a new medication called tezepelumab, to see if it can help improve the health of people with this condition.

The study aims to discover if tezepelumab can reduce the number of COPD flare-ups (when symptoms suddenly get worse) and generally make people feel better. It also carefully checks for any side effects to make sure the medicine is safe. Understanding both the benefits and risks is crucial before a new medicine can be made widely available.

To make sure the results are fair and accurate, some participants will receive the new medicine, while others will get a 'placebo'. A placebo looks just like the real medicine but contains no active drug. Neither the participants nor their doctors will know who is getting which, which helps prevent any bias. This is a common and important way to test new medicines effectively.

Key takeaways

This study is testing a new medicine, tezepelumab, for moderate to very severe COPD.
It aims to see if the medicine improves symptoms, reduces flare-ups, and is safe.
Some participants will receive the new medicine, others a placebo.
Participation involves monthly injections and regular health checks for 15-21 months.
You must be 40-80 years old with a specific COPD history to be eligible.

Who may be eligible?

To join this study, you generally need to be an adult between 40 and 80 years old and have been diagnosed with COPD for at least a year. Your COPD should be moderate to very severe, and you should have experienced at least two moderate flare-ups or one severe flare-up in the past year, with at least one needing steroid treatment.

You would also need to be a current or past smoker with a certain smoking history. It's important that your general health is stable, and you shouldn't have other significant lung conditions like asthma or active tuberculosis. Certain other serious health conditions or medications would also mean you couldn't take part.

Quick self-check

Are you between 40 and 80 years old?
Have you been diagnosed with COPD for at least one year?
Have you had at least two moderate or one severe COPD flare-up in the last year?
Are you currently on, or have you been on, standard inhaled COPD medicines (like triple or dual therapy)?
Do you have a history of smoking (past or present, for at least 10 'pack-years')?
Do you have stable health conditions without other significant lung diseases like asthma?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will visit a study clinic regularly. You'll receive the study medicine, tezepelumab, or a placebo, as an injection under your skin once a month. The treatment period will last for at least one year and up to about 18 months.

Throughout the study, the research team will keep a close eye on your health. This will involve regular check-ups, tests, and discussions about how you're feeling and any changes you notice. After the treatment period finishes, there will be an extra 12-week safety follow-up period to monitor your health further. The total time you'd be involved in the study would be approximately 15 months to 1 year and 9 months.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new investigational treatment for your COPD that could improve your symptoms or reduce flare-ups. However, there's also the chance you might receive a placebo and therefore not experience direct benefits from the active drug. As with any new medicine, there could be side effects or risks that are not fully known yet. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (301)

Research Site
Foley, United States· Recruiting
Research Site
Mobile, United States· Recruiting
Research Site
Sheffield, United States· Recruiting
Research Site
Phoenix, United States· Not yet recruiting
Research Site
Phoenix, United States· Recruiting
Research Site
Tucson, United States· Withdrawn
Research Site
Garden Grove, United States· Recruiting
Research Site
Newport Beach, United States· Recruiting
Research Site
Torrance, United States· Recruiting
Research Site
Clearwater, United States· Recruiting
Research Site
Cutler Bay, United States· Recruiting
Research Site
Cutler Bay, United States· Recruiting

+289 more sites — see the official record for the full list.

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease, a group of lung diseases that block airflow and make breathing difficult.

What is 'tezepelumab'?

Tezepelumab is a new medicine being tested to see if it can help people with moderate to very severe COPD.

What is a 'placebo'?

A placebo is a dummy medicine that looks like the real medicine but doesn't contain any active drug. It helps researchers compare the effects accurately.

How is the medicine given?

The study medicine is given as an injection under the skin once a month.

How long does the study last?

The treatment part of the study lasts for at least 1 year, and up to about 18 months, with an extra 12-week safety follow-up.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.