Celecoxib for Chronic Rhinosinusitis

Not currently recruiting at 1 trial location

Overseen By Taciano Rocha, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

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

Must not be taking: Anticoagulants, ACE inhibitors, Diuretics, others

Disqualifiers: Opioid abuse, Heart disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests celecoxib, a medication that might reduce inflammation and pain for people with chronic rhinosinusitis (long-lasting sinus swelling) who have aspirin-exacerbated respiratory disease. Researchers aim to determine if celecoxib can improve sinus surgery outcomes and reduce the need for pain medication afterward. Participants will take either celecoxib or a placebo (a pill with no active drug) for seven days post-surgery. This study suits those with chronic sinus issues, who have undergone endoscopic sinus surgery, and who do not have allergies to certain medications. As a Phase 4 trial, celecoxib is already FDA-approved and proven effective, with research helping to understand its benefits for more patients.

Will I have to stop taking my current medications?

You may need to stop taking certain medications if you join this trial. Specifically, if you are using anticoagulants, ACE inhibitors, diuretics, lithium, cidofovir, carbamazepine, or antidepressants, you might have to stop them due to potential interactions with celecoxib.

What is the safety track record for celecoxib?

Studies have shown that celecoxib is generally safe for use. This medication, a type of nonsteroidal anti-inflammatory drug (NSAID), specifically targets inflammation and causes fewer stomach problems than older NSAIDs. Research suggests that celecoxib may be gentler on the stomach compared to other pain relievers.

For patients undergoing surgery, celecoxib can reduce the need for opioids, which are strong and potentially addictive painkillers. One study found that using celecoxib after surgery led to a significant decrease in opioid use—over 76% less. It also reduced nausea and vomiting without causing additional recovery issues.

Overall, celecoxib has a strong safety record and is already approved for other conditions, indicating it is well-tolerated. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Celecoxib is unique because it is a non-steroidal anti-inflammatory drug (NSAID) typically used for pain relief and inflammation but is being explored for chronic rhinosinusitis. Unlike standard treatments like corticosteroids and antibiotics, celecoxib works by specifically inhibiting the COX-2 enzyme, which could potentially reduce inflammation with fewer side effects. Researchers are excited about this treatment because it may offer a novel approach to managing postoperative inflammation and pain, potentially reducing the reliance on narcotics and their associated risks.

What evidence suggests that celecoxib might be an effective treatment for chronic rhinosinusitis?

In this trial, participants will be divided into two groups to assess the effectiveness of celecoxib for chronic rhinosinusitis. Studies have shown that celecoxib, a type of medication, can help reduce pain and swelling after surgery. In one study, patients who took celecoxib felt better than those who took a placebo. Another study found that celecoxib worked as well as another common pain reliever. Celecoxib also appears to slow the growth of certain cells that can cause sinus problems. This medicine is already approved for treating pain and swelling in other conditions, supporting its effectiveness. ^{5 6 7 8 9}

Who Is on the Research Team?

Leigh Sowerby, MD

Principal Investigator

Western University, Canada

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic rhinosinusitis and nasal polyps, specifically in the context of aspirin-exacerbated respiratory disease (AERD), who need surgery after other treatments haven't worked. Participants must be able to understand English and give informed consent. Exclusions include pregnant or breastfeeding women, those with certain heart, kidney, liver conditions, bleeding disorders, drug abuse history or taking conflicting medications.

Inclusion Criteria

I have severe sinusitis with nasal polyps and asthma, needing surgery after other treatments failed.

I understand the study and agree to participate.

Exclusion Criteria

I am not taking medications like blood thinners, blood pressure pills, water pills, lithium, cidofovir, carbamazepine, or antidepressants.

I have a blood clotting disorder.

I have been diagnosed with ischemic heart disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive celecoxib or placebo for 7 days post endoscopic sinus surgery

1 week

1 visit (in-person) for surgery, daily self-reporting

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in POSE, SNOT-22, and LKES scores

4 weeks

2 visits (in-person) at 1 week and 4 weeks post-operatively

Postoperative Monitoring

Daily assessment of postoperative pain level and compliance with nasal saline rinses

3 weeks

Daily self-reporting

What Are the Treatments Tested in This Trial?

Interventions

• Celecoxib
• Placebo

Trial Overview

The study tests whether Celecoxib, a COX-2 inhibitor painkiller can reduce inflammation and pain better than a placebo after sinus surgery in AERD patients. It's randomized which means participants are put into the Celecoxib or placebo group by chance.

How Is the Trial Designed?

Group I: Celecoxib Group Experimental Treatment 1 Intervention

Patients will receive the interventional drug for 7 days post endoscopic sinus surgery. These patients will also receive a prescription for tramadol (50 mg PO Q6H PRN x 10 tablets), to be used as needed for breakthrough pain. Patients will also be permitted to take acetaminophen for breakthrough pain as needed and will be encouraged to use acetaminophen prior to narcotic usage. Finally, they will be prescribed a nasal saline rinse, which is to be started on postoperative day one.

Group II: Control Group Placebo Group 1 Intervention

Patients will receive the placebo for 7 days post endoscopic sinus surgery. These patients will also receive a prescription for tramadol (50 mg PO Q6H PRN x 10 tablets), to be used as needed for breakthrough pain. Patients will also be permitted to take acetaminophen for breakthrough pain as needed and will be encouraged to use acetaminophen prior to narcotic usage. Finally, they will be prescribed a nasal saline rinse, which is to be started on postoperative day one.

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

668

Recruited

424,000+

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

Lead Sponsor

Trials

686

Recruited

427,000+

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

Lead Sponsor

Trials

678

Recruited

421,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Western University, Canada

Collaborator

Trials

270

Recruited

62,500+

London Health Sciences Centre

Collaborator

Trials

151

Recruited

60,400+

University of Western Ontario, Canada

Collaborator

Trials

168

Recruited

320,000+

Published Research Related to This Trial

Celecoxib shows a lower risk of cardiovascular events and all-cause mortality compared to non-selective non-steroidal anti-inflammatory drugs (NSAIDs), with risk ratios of 0.89 and 0.81 respectively, based on a meta-analysis of 21 trials involving rheumatoid arthritis and osteoarthritis patients.

The study suggests that celecoxib is relatively safe for cardiovascular health in these patients, but its safety in individuals taking aspirin or those with existing cardiovascular diseases remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular safety of celecoxib in rheumatoid arthritis and osteoarthritis patients: A systematic review and meta-analysis. Cheng, BR., Chen, JQ., Zhang, XW., et al.[2022]

Celecoxib is equally effective as other non-steroidal anti-inflammatory drugs (NSAIDs) in treating osteoarthritis and rheumatoid arthritis, based on a systematic review of 9 trials involving 15,187 patients.

Celecoxib significantly improves gastrointestinal safety, with a 46% lower withdrawal rate due to adverse gastrointestinal events and a 71% lower incidence of ulcers compared to other NSAIDs, making it a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, tolerability, and upper gastrointestinal safety of celecoxib for treatment of osteoarthritis and rheumatoid arthritis: systematic review of randomised controlled trials. Deeks, JJ., Smith, LA., Bradley, MD.[2022]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0196070910002425

The effect of hypoxia and cycloxygenase inhibitors on ...

Celecoxib significantly reduces fibroblasts proliferation and should be considered for treating NP patients, though further investigation is required.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12129994/

Study protocol for a randomized double-blinded placebo ...

Minimal clinically important difference for the 22-item sinonasal outcome test in medically managed patients with chronic rhinosinusitis.

3.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/abs/10.1002/alr.22506

Multicenter study on the effect of nonsteroidal anti‐ ...

Multicenter study on the effect of nonsteroidal anti-inflammatory drugs on postoperative pain after endoscopic sinus and nasal surgery.

4.

journals.sagepub.com

journals.sagepub.com/doi/pdf/10.1177/147323000203000212

Efficacy of Celecoxib in Treating Symptoms of Viral ...

In conclusion, the results of this randomized, double-blind study have shown that celecoxib 200 mg once daily is as effective as diclofenac 150 mg/day in ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0149291801800047

Comparison of once-daily and twice ...

For all measures of efficacy, at all assessments, improvements from baseline in both celecoxib groups were superior to that seen in the placebo group (P < 0.05) ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12484377/

Current Evidence on Celecoxib Safety in the Management of ...

Celecoxib appears to offer better gastrointestinal safety than non-selective NSAIDs. Although data on cardiovascular, renal, and mortality ...

7.

liebertpub.com

liebertpub.com/doi/full/10.1089/fpsam.2019.29014.new

The Efficacy of Oral Celecoxib Following Surgical ...

With the addition of postoperative celecoxib (200 mg b.i.d.) for 5 days, there was a 76.2% decrease in milligrams of opioid use and an 83.4% ...

8.

clinicaltrial.be

clinicaltrial.be/en/details/60381?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_eligible=0&only_active=0

Effect of Celecoxib on Postoperative Analgesia and Diseas...

The investigators hypothesize that supplementation with celecoxib can potentially improve surgical outcomes and reduce the postoperative usage ...

9.

journals.sagepub.com

journals.sagepub.com/doi/full/10.1089/fpsam.2019.29014.new

The Efficacy of Oral Celecoxib Following Surgical ...

Oral celecoxib appears to be effective in decreasing opioid consumption and nausea/vomiting rates after rhinoplasty without increasing surgical complications.