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Celecoxib for Chronic Rhinosinusitis

Phase 4

Waitlist Available

Led By Leigh Sowerby, MD

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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of CRS with nasal polyposis in the setting of AERD, and requiring FESS for management after failing medical management per the Canadian clinical practice guidelines for acute and chronic sinusitis

Be older than 18 years old

Must not have

Known coagulopathy

Known Ischemic Heart Disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6h after surgery; 24 hours after surgery; 7 days post-surgery (daily); at the 14th day; and at the 21st day.

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will test if celecoxib can help improve surgical outcomes and reduce postoperative pain for people with aspirin-exacerbated respiratory disease and Chronic rhinosinusitis following endoscopic sinus surgery.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Celecoxib may cause stomach ulcers or bleeding, worsen heart failure or kidney problems if pre-existing conditions are present. It might also interact with other drugs affecting blood clotting and blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a blood clotting disorder.

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I have been diagnosed with ischemic heart disease.

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I have been diagnosed with mild to moderate heart failure.

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I am not taking medications that affect serotonin levels.

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I am allergic to acetaminophen, opioids, or certain anti-inflammatory drugs.

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I have had stomach ulcers or bleeding.

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I am not pregnant or breastfeeding.

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I have kidney or liver problems.

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I have been diagnosed with inflammatory bowel disease.

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I have chronic pain or I use opioids regularly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6h after surgery; 24 hours after surgery; 7 days post-surgery (daily); at the 14th day; and at the 21st day.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6h after surgery; 24 hours after surgery; 7 days post-surgery (daily); at the 14th day; and at the 21st day.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6h after surgery; 24 hours after surgery; 7 days post-surgery (daily); at the 14th day; and at the 21st day. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Post FESS changes in the Lund-Kennedy Endoscopic Score (LKES)

Post FESS changes in the Peri-Operative Sinus Endoscopy (POSE) score

Post FESS changes in the validated Sino-Nasal Outcome Test 22 (SNOT-22) questionnaire

Secondary study objectives

Post FESS changes in the pain level assessed via the 10-point visual analogue scale

Other study objectives

Amount of analgesic medication taken on postoperative days 0-7, self reported by the patients.

Compliance with prescribed nasal saline rinses, self reported by the patients.

Number of epistaxis events, self reported by the patients.

+1 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Celecoxib GroupExperimental Treatment1 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 GroupPlacebo Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Celecoxib

2019

Completed Phase 4

~1740

0 / 11Eligibility criteria met