Celecoxib for Chronic Rhinosinusitis

Recruiting at 1 trial location

Overseen by Leigh Sowerby, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

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

Prior Safety Data

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

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.

Treatment Details

Interventions

• Celecoxib (COX-2 Inhibitor)
• Placebo (Drug)

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+