Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo- Controlled Phase 3 Efficacy and Safety Study of Benralizumab in Patients with Eosinophilic Chronic Rhinosinusitis with Nasal Polyps (ORCHID)

This important study, known as ORCHID, is testing a new medicine called benralizumab for adults who have severe chronic rhinosinusitis with nasal polyps (CRSwNP) and asthma. CRSwNP causes swelling and growths, called polyps, inside the nose and sinuses, making it hard to breathe. The study wants to find out if benralizumab can help shrink these polyps, make breathing easier, and improve the sense of smell. Participants will also use a standard nasal spray. We're comparing benralizumab to a dummy treatment (placebo) to see if it's both safe and effective. The goal is to improve the quality of life for people living with these conditions.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

AstraZeneca AB

Enrolment target

Start

14 Feb 2024

Severe CRSwNP patients with asthma.

What is this study about?

This study, called ORCHID, is designed to investigate a new medication called benralizumab. It's for adults who have a condition called chronic rhinosinusitis with nasal polyps (CRSwNP), especially if it's severe and they also have asthma. CRSwNP causes long-lasting inflammation in the nose and sinuses, leading to growths called nasal polyps. These polyps can block the nose, make it hard to smell, and cause discomfort. The study aims to see if benralizumab can help reduce the size of these polyps, improve nasal blockage, and generally make patients feel better.

Participants in the study will be given either benralizumab or a 'dummy' treatment, called a placebo, alongside a standard nasal spray that contains mometasone furoate. Neither the patients nor their doctors will know who is getting the real medication and who is getting the placebo. This is to ensure the results are fair and accurate. Researchers will carefully check how well the treatments work by looking at the size of the nasal polyps and how much the nose blockage improves over time.

Beyond just polyp size and blockage, the study will also look at other important things. This includes how much a patient's sense of smell improves, their overall quality of life (using a special questionnaire), and if they need nasal polyp surgery or strong steroid medicines for their polyps less often. By looking at all these different aspects, the study hopes to get a full picture of how benralizumab might help people with severe nasal polyps and asthma.

Key takeaways

Tests a new medicine (benralizumab) for severe nasal polyps and asthma.
Compares it to a dummy treatment (placebo) for fair results.
Aims to shrink polyps, improve breathing, and sense of smell.
Involves regular clinic visits and symptom monitoring.
Participants will also use a standard nasal spray.
Could offer a new treatment option for this condition.

Who may be eligible?

This study is looking for adult volunteers, aged 18 years or older, who have severe chronic rhinosinusitis with nasal polyps (CRSwNP) and also suffer from asthma. To be considered, you would typically have a diagnosis of moderate or severe asthma that is not fully controlled, even with ongoing treatment. Your CRSwNP should also be significant, affecting your daily life.

There might be some specific medical conditions or medications that would prevent someone from joining, as the researchers need to ensure it's safe for everyone involved. For instance, if you've recently had certain surgeries, have other serious health problems, or are taking certain medicines, you might not be able to take part.

The best way to find out if you qualify is to talk to your doctor or the study team. They will carefully review your medical history to see if this study is a good fit for you.

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.

Are you 18 years old or older?
Do you have a diagnosis of severe chronic rhinosinusitis with nasal polyps (CRSwNP)?
Do you also have asthma?
Are you willing to use a specific nasal spray throughout the study?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to one of two groups by chance: one group will receive the new medicine, benralizumab, and the other will receive a placebo (dummy treatment). You'll also be using a standard nasal spray throughout the study. Neither you nor your study doctor will know which treatment you are receiving.

Participation will involve regular visits to the clinic where you'll have various assessments. These might include physical examinations, blood tests, and special checks of your nasal polyps using a small camera (endoscopy). You'll also be asked to complete questionnaires about your symptoms and how you're feeling. These visits help the researchers monitor your health, evaluate the treatment's effects, and ensure your safety. The total duration of your involvement in the study, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving a new investigational treatment that might improve your nasal polyps and asthma symptoms, and contributing to medical knowledge that could help others in the future. However, there are also potential risks; you might experience side effects from the study medication, or the treatment might not be effective for you. You have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
Bulgaria
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Unverified
Hungary
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Unverified
Poland
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Unverified
Belgium

Common questions

What are nasal polyps?

Nasal polyps are soft, painless, non-cancerous growths that hang down like teardrops or grapes inside your nose or sinuses. They can cause blockage and make it hard to breathe.

What is benralizumab?

Benralizumab is an investigational medicine being studied to see if it can help reduce inflammation and shrink nasal polyps in people who have specific types of long-lasting inflammation.

What does 'placebo-controlled' mean?

It means some people get the new medicine, and others get a 'dummy' treatment that looks the same but has no active ingredient. This helps researchers fairly compare the new medicine's effects.

Will I still use my usual nasal spray?

Yes, all participants in this study will also use a specific standard nasal spray (containing mometasone furoate) along with either the study medicine or the placebo.

What is asthma and why is it mentioned?

Asthma is a lung condition that causes breathing difficulties. In this study, they're specifically looking at people who have both nasal polyps and asthma, as these conditions are often linked.