Active not recruitingPHASE4INTERVENTIONAL

Effect of Celecoxib on Postoperative Analgesia and Disease Severity in AERD Patients with CRS

This study is investigating if a medication called celecoxib helps patients with long-term sinus inflammation and a condition where aspirin causes breathing problems, feel better after sinus surgery. Often, people need strong painkillers after this type of surgery. Researchers hope celecoxib might reduce pain and swelling, meaning patients wouldn't need as many strong painkillers, and could recover more comfortably. They also want to check if celecoxib is safe for these patients, ensuring it doesn't cause problems like increased bleeding or make their breathing issues worse. If successful, this could offer a better way to manage pain and recovery for many people.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Enrolment target

Start

18 Feb 2020

Estimated completion

01 Jul 2026

Chronic Rhinosinusitis with Nasal Polyps Aspirin-exacerbated Respiratory Disease

What is this study about?

You're probably reading this because you, or someone you know, experiences ongoing sinus problems, possibly with growths in the nose (nasal polyps), and also has issues with aspirin, where it can trigger breathing difficulties. This combination of conditions can be really uncomfortable, leading to blocked noses, discharge, facial pain, and even a reduced sense of smell. While not life-threatening, it can truly impact your daily life and how you feel.

Sometimes, usual treatments like sprays or washes aren't enough, and surgery becomes an option. This type of surgery, called endoscopic sinus surgery, helps clear out the sinuses and improve breathing. However, like any surgery, it can lead to pain and swelling afterwards. Doctors often prescribe strong painkillers, like opioids, to manage this. This study is testing if a different medicine, called celecoxib, can help with this post-surgery pain and swelling. Celecoxib is a type of anti-inflammatory medicine.

The main idea behind this study is to see if taking celecoxib after sinus surgery could make your recovery smoother. Researchers want to find out if it can reduce your pain and help with inflammation, potentially meaning you'd need fewer strong painkillers. Importantly, they also want to check that celecoxib doesn't cause problems for people with aspirin sensitivity or increase risks like bleeding. By joining, you'd be helping doctors understand if this medicine could offer a better, safer way to recover for many others in the future.

Key takeaways

Tests if celecoxib helps manage pain after sinus surgery.
Aims to reduce reliance on strong painkillers.
Specifically for people with long-term sinus issues and aspirin sensitivity.
Compares celecoxib to a dummy pill (placebo).
Focuses on safety, especially for breathing and bleeding.
Could improve recovery for future patients.

Who may be eligible?

To join this study, we're looking for adults aged 18 or older who have long-term sinus inflammation with nasal polyps, and also experience breathing problems when exposed to aspirin. You would also need to be scheduled for sinus surgery because other treatments haven't worked well for you. It's important that you're able to understand what the study involves and agree to take part.

There are also some reasons why you might not be able to join. For example, if you're allergic to medicines like paracetamol, certain strong painkillers (opioids), or celecoxib itself, this study wouldn't be suitable. If you've had issues with drug abuse, or have certain health conditions like heart problems, stomach ulcers, inflammatory bowel disease, or severe kidney or liver issues, you wouldn't be able to participate. We're also unable to include women who are pregnant or breastfeeding, or people who are already in another medical study.

Finally, if you take certain medications that could react badly with celecoxib – such as some blood thinners, blood pressure medicines, or specific antidepressants – or if you have a condition that affects blood clotting, you wouldn't be able to join. Your study doctor will go through all of these in detail to make sure it's safe 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 or older?
Do you have chronic sinus problems with nasal polyps and also react badly to aspirin?
Are you scheduled for sinus surgery because other treatments haven't worked?
Can you understand and agree to what the study involves?
Are you not pregnant or breastfeeding?
Do you not have serious heart, stomach, kidney, or liver conditions, or severe bleeding disorders?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to receive either celecoxib or a placebo (a dummy pill containing no medicine). Neither you nor your study doctor would know which you are taking. You would receive this treatment after your sinus surgery.

Your involvement would include regular check-ups with the study team. They will monitor your pain levels, how you're recovering, and any medicines you take for pain after surgery. You'll also be asked to keep a record of any pain relief you use. The study team will need to perform some assessments to check for inflammation. The total duration of your participation would be from your decision to join through your recovery period, with follow-up appointments.

Potential risks and benefits

Taking part in this study could potentially offer you benefits, such as improved pain relief after your surgery and reduced need for strong painkillers. However, there's no guarantee that you will personally benefit. There are also potential risks, as with any medication or study. These could include side effects from celecoxib, although the study aims to check for safety, especially regarding bleeding or breathing issues. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

St. Joseph's Healthcare London
Verified postcode
London, Canada
King Abdulaziz University Hospital
Verified postcode
Jeddah, Saudi Arabia

Common questions

What is celecoxib?

Celecoxib is a medicine that helps reduce pain and swelling, similar to some common painkillers but with a specific way of working.

What is a placebo?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. It helps us compare how well the actual medicine works.

Will I know if I'm getting celecoxib or the placebo?

No, this is a 'blinded' study, so neither you nor your doctors will know which treatment you are receiving until after the study is over. This ensures the results are fair.

What happens if I feel worse during the study?

Your safety is the top priority. The study team will monitor you closely. If you feel unwell or have concerns, you should inform them immediately, and they can adjust your care as needed. You can also leave the study at any time.

How long will I be in the study?

Your participation will cover the period after your surgery and include follow-up visits to check on your recovery and how you're feeling.