All studies
Active not recruitingPHASE3INTERVENTIONAL

A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab

This study is for adults in the UK who have ongoing sinus problems and growths called nasal polyps that block their nose and cause other symptoms. Researchers want to see how a new medicine, tezepelumab, affects these symptoms. The study will look at how much people's stuffy nose feels better and if their overall sinus symptoms improve after starting this treatment. Approximately 60 hospitals in 10 countries will be involved, including some in the UK. Participants will receive treatment for 24 weeks and be followed up for a total of 36 weeks to check on their health. This research aims to understand if tezepelumab could be a helpful treatment option for this condition.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
AstraZeneca
Enrolment target
181
Start
03 Dec 2024
Estimated completion
13 Jan 2027

What is this study about?

This study is looking into a new medicine called tezepelumab. It's designed for adults who have a long-term condition called chronic rhinosinusitis with nasal polyposis, often shortened to CRSwNP. This condition causes ongoing inflammation in your nose and sinuses, leading to symptoms like a blocked nose, runny nose, and sometimes a reduced sense of smell. People with CRSwNP also develop non-cancerous growths called nasal polyps inside their nose.

The main goal of this study is to see if tezepelumab can help improve these symptoms for people whose polyps are severe enough that surgery has been considered. Researchers will specifically be looking at how well it helps with a blocked nose and overall sinus symptoms, as reported by the patients themselves. They're also interested in this medicine for people who have both CRSwNP and asthma.

By taking part, you would be helping doctors understand if tezepelumab could be a good treatment choice for people living with ongoing nasal polyps. This could potentially offer a new way to manage symptoms and improve quality of life for many individuals.

Key takeaways

  • This study evaluates a new medicine, tezepelumab, for severe nasal polyps.
  • It's for adults with chronic rhinosinusitis and nasal polyps where surgery has been considered.
  • The study assesses improvements in blocked nose and overall sinus symptoms.
  • Treatment lasts 24 weeks, with check-ups every 4 weeks.
  • Total study involvement is up to 40 weeks.
  • Participation could offer new treatment options but has potential risks.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older. You must have been diagnosed with chronic rhinosinusitis with nasal polyps for at least a year, and your condition needs to be severe enough that surgery has been discussed as an option. This is usually checked by measuring your nasal polyp size and how stuffy your nose feels.

Your nasal polyps should be causing ongoing symptoms like a runny nose, problems with smell, or poor sleep for at least two months. You also need to have tried standard treatments, including nasal sprays containing steroids, and have been using them regularly for at least a month before joining the study.

Additionally, you should have either had a steroid treatment (like tablets or an injection) for your polyps in the last year (but not in the last three months), or have a history of nasal polyp surgery. The study also has some specific requirements regarding female participants' ability to become pregnant, or if they are postmenopausal.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with chronic rhinosinusitis with nasal polyps for at least one year?
  3. Are your nasal polyps severe enough that surgery has been considered?
  4. Do you currently have ongoing symptoms like a blocked/runny nose, reduced smell, or poor sleep due to your polyps?
  5. Have you been regularly using nasal steroid sprays for at least a month?
  6. Have you either had oral/injectable steroids for your polyps in the last year (but not in the last three months), or had previous nasal polyp surgery?
Answer every question to see your result.

What does participation involve?

If you join this study, the total time you'd be involved is up to 40 weeks, which is about 9-10 months. You'll receive the study medicine, tezepelumab, for 24 weeks. During this treatment period, you'll have visits to the study clinic about every 4 weeks. These visits are important for the doctors to check how you're doing, understand if the medicine is helping your symptoms, and monitor your safety.

During these appointments, the study team will ask you questions about your symptoms, specifically how blocked your nose feels and your overall sinus experience. They will use special questionnaires to track these changes. After the 24 weeks of treatment, there will be a follow-up period of about 12 weeks to continue monitoring your health and any long-term effects of the medicine.

Potential risks and benefits

Like all medicines and studies, there could be potential benefits and risks. You might find that your nasal blockage and other sinus symptoms improve with tezepelumab, which could enhance your quality of life. However, there's also a chance the medicine might not work for you, or you could experience side effects. All possible side effects will be explained to you in detail before you decide to take part. It's very important to remember that joining this study is completely your choice, and you are free to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (41)

  • Research Site
    Verified postcode
    Newport Beach, United States
  • Research Site
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    Chicago, United States
  • Research Site
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    Chestnut Hill, United States
  • Research Site
    Verified postcode
    Columbia, United States
  • Research Site
    Verified postcode
    Plovdiv, Bulgaria
  • Research Site
    Verified postcode
    Sofia, Bulgaria
  • Research Site
    Verified postcode
    Sofia, Bulgaria
  • Research Site
    Verified postcode
    Hamilton, Canada
  • Research Site
    Verified postcode
    Québec, Canada
  • Research Site
    Verified postcode
    Québec, Canada
  • Research Site
    Verified postcode
    Le Kremlin-Bicêtre, France
  • Research Site
    Verified postcode
    Marseille, France

Common questions

What are nasal polyps?

Nasal polyps are soft, non-cancerous growths that can appear inside your nose and sinuses. They can cause symptoms like a blocked nose and problems with your sense of smell.

What is chronic rhinosinusitis?

This is a long-lasting inflammation of the lining of the nose and sinuses, causing symptoms like a blocked nose, pain, drainage, and reduced smell for 12 weeks or more.

What does 'surgery-eligible' mean?

It means your nasal polyps are severe enough that doctors have considered surgery as a possible treatment for them.

What is tezepelumab?

Tezepelumab is a new medicine being studied. It works by targeting specific pathways in the body that are involved in inflammation.

Will I have to pay to take part?

No, you will not have to pay to take part in this study. All study-related treatments and assessments are usually covered by the study organisers.

How to find out more

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

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