Celecoxib for Chronic Rhinosinusitis

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

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

Compensation: Varies

Number of Visits: 3

Duration: 1 week

44 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a proposed randomized prospective study to evaluate both the anti-inflammatory and analgesic effects of a COX-2 inhibitor, celecoxib, in patients with aspirin-exacerbated respiratory disease and Chronic rhinosinusitis following endoscopic sinus surgery. The investigators hypothesize that supplementation with celecoxib can potentially improve surgical outcomes and reduce the postoperative usage of opioid analgesics without an increased risk of bleeding or asthma exacerbation

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 data supports the effectiveness of the drug Celecoxib for treating chronic rhinosinusitis?

Celecoxib works by blocking an enzyme called COX-2, which is involved in inflammation. Research shows that COX-2 is active in chronic rhinosinusitis, suggesting that Celecoxib might help reduce inflammation in this condition. ^{1 2 3 4 5}

Is celecoxib generally safe for humans?

Celecoxib has been studied for safety in conditions like rheumatoid arthritis and osteoarthritis, showing it is generally safe for the heart and stomach compared to other similar drugs or a placebo. ^{4 6 7 8 9}

How does the drug celecoxib differ from other treatments for chronic rhinosinusitis?

Celecoxib is unique because it specifically targets and inhibits cyclo-oxygenase-2 (COX-2), an enzyme involved in inflammation, which may reduce side effects compared to traditional nonselective NSAIDs. This selective action could potentially make it a novel option for managing inflammation in chronic rhinosinusitis. ^{4 6 8 10 11}

Research Team

Leigh Sowerby, MD

Principal Investigator

Western University, Canada

Eligibility Criteria

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 am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

An evaluation of the efficacy of indomethacin in experimentally induced acute sinusitis in rats. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The role of antibiotics in the treatment of acute rhinosinusitis in children: a systematic review. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Expression of cyclooxygenase and lipoxygenase enzymes in nasal polyps of aspirin-sensitive and aspirin-tolerant patients. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Systemic corticosteroid therapy for acute sinusitis. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Involvement of mitogen-activated protein kinases and nuclear factor kappa B pathways in signaling COX-2 expression in chronic rhinosinusitis. [2021]

6. Thailand pubmed.ncbi.nlm.nih.gov

Efficacy of celecoxib on controlling irregular uterine bleeding secondary to Jadelle use. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular safety of celecoxib in rheumatoid arthritis and osteoarthritis patients: A systematic review and meta-analysis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Comparison of different loading dose of celecoxib on postoperative anti-inflammation and analgesia in patients undergoing endoscopic nasal surgery-200 mg is equivalent to 400 mg. [2015]

9. England 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. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

New immunohistologic findings on the differential role of cyclooxygenase 1 and cyclooxygenase 2 in nasal polyposis. [2005]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical pharmacokinetics and pharmacodynamics of celecoxib: a selective cyclo-oxygenase-2 inhibitor. [2018]