Chronic Rhinosinusitis with Nasal PolypsPhase 4NCT04147013
Effect of Celecoxib on Postoperative Analgesia and Disease Severity in AERD Patients with CRS
A Phase 4 study testing Celecoxib in people with Chronic Rhinosinusitis with Nasal Polyps and Aspirin-exacerbated Respiratory Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis with Nasal Polyps, Aspirin-exacerbated Respiratory Disease
- What is being tested?
- Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 Feb 2020to Jul 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years of age or older;
- 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;
- Capable, in the opinion of the primary investigator, of providing informed consent to participate in the study. Participants are required to sign an informed consent form indicating they understand the purpose and nature of the study, and that they are willing to participate.
Who cannot join
- Known allergies/sensitivities to acetaminophen, opioid, or COX-2 inhibitor NSAIDs
- Inability to read and understand English
- Inability to keep record of exact use of analgesics post-FESS
- History of opioid/narcotic abuse
- Known Ischemic Heart Disease
- Known Mild to moderate congestive heart failure
Show all 23Show fewer
- Stomach ulceration or bleeding
- Known Inflammatory bowel disease
- Chronic pain or chronic opioid use
- Known renal or hepatic impairment
- Known coagulopathy
- Women who are pregnant or breastfeeding
- Known inability to complete follow-up visits
- Current participation in another clinical trial at time of initial visit
- Use of other medications that impact the serotonin pathway
- Use of medications with potential interactions with celecoxib:
- Anticoagulants (warfarin, clopidogrel, dabigatran, enoxaparin)
- ACE inhibitors (e.g. captopril, lisinopril)
- Diuretics (e.g. furosemide)
- Lithium
- Cidofovir
- Carbamazepine
- Antidepressants
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Effect of Celecoxib on Postoperative Narcotic Use and Disease Severity in Patients with Aspirin-exacerbated Respiratory Disease and Chronic Rhinosinusitis: a Randomised Controlled 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
Read the detailed description
- Background: Chronic rhinosinusitis (CRS) affects up to 5% of Canadians and is associated with significant morbidity. It is characterized by inflammation of the mucosa of the nose and paranasal sinuses of at least 12 consecutive weeks' duration. Patients suffering from CRS are bothered on a daily basis by nasal obstruction, nasal discharge, facial pain, and an impaired sense of smell among other symptoms. Although not typically a life-threatening condition, CRS can drastically reduce a patient's quality of life as well as their workplace productivity. In fact, this has been demonstrated in the literature, with one study estimating the annual productivity cost of refractory CRS at about $10,000 per patient. Fortunately, effective management strategies are available. Mild to moderate disease can often be managed safely with long term use of topical glucocorticoids and nasal saline lavage. For more severe CRS unresponsive to appropriate medical therapy, oral glucocorticoids can be effective in the short term, but surgical treatment can help achieve long-term control of symptoms when initial medical therapy has failed. This is typically done via endoscopic sinus surgery (ESS), and its goal is to re-establish physiological patterns of ventilation and mucociliary clearance in patients with CRS, as well as establish access for topical therapy delivery. ESS is considered the gold standard of management for CRS and has proven to be highly effective in reducing the burden of inflammatory tissue and minimizing patient morbidity. Although developed as a minimally invasive technique to avoid the morbidity of open sinus surgery, ESS still entails some degree of surgical trauma, postoperative pain, and inflammation. Intraoperative local anesthetic infiltration is routinely performed but is insufficient to control pain in the immediate postoperative period. Patients often require some form of systemic analgesia and this usually consists of some combination of acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, and opioids. However, there is currently no consensus in the literature regarding the optimal analgesic regimen after ESS. Interestingly, in patients with aspirin-exacerbated respiratory disease (AERD) a triad of asthma, CRS, and aspirin (ASA/NSAID sensitivity), NSAIDs are classically associated with worsening of CRS symptoms. However, cyclooxygenase-2 (COX-2) inhibitors, a selective type of NSAID, have recently been studied as post-ESS analgesics and suggested as possible alternatives to opioids, which have many known potential adverse effects. These agents have also been studied for their anti-inflammatory properties in patients undergoing ESS and have been shown to decrease the levels of circulating prostaglandins in this population. Thus, AERD patients are a particularly important population in which to assess the effect of COX-2 inhibitors on post-operative pain and inflammation. This randomized, prospective study will evaluate both the anti-inflammatory and analgesic effects of a COX-2 inhibitor, celecoxib, in patients with AERD and CRS 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.
- The objectives of this study are: 1) to determine whether the addition of celecoxib to the FESS post-operative analgesia regimen can alter subjective and objective recovery from CRS signs and symptoms, and 2) to determine whether the addition of the COX-2 inhibitor, celecoxib, to the endoscopic sinus surgery post-operative analgesia regimen can reduce the amount of opioid narcotic used by patients for breakthrough pain.
- Trial Design: The study is a prospective, double-blinded, randomized controlled study and will be conducted at St. Joseph's Hospital in London, ON (CAN). There will be two study arms with 1:1 allocation, one arm will receive the study treatment and the other will receive a placebo;
- Sample Size Calculation: The initial pre-study sample size was calculated with 80% power at a significance level of 0.05. For the primary objective, previous studies have established that a 40% difference on the Lund-Kennedy Endoscopic Score would be clinically relevant. The statistical power was assumed to be 80%, and the needed significance level (2-tailed alpha error) was assumed to be 5%. Based on the literature, a mean difference of 3.4 and an SD of 2.6 for the Lund-Kennedy endoscopic reporting system was used for calculation, giving a sample size of 22. For the secondary objective, the sample size was calculated as follows. Assuming a difference of 2 of mean pain score (with a standard deviation of 2) on the Numeric Rating scale as significant, a sample size of 16 in each group is required. It has been reported elsewhere a total of 4.5 (+/-4.4) milligram morphine equivalent for patients undergoing a sinus surgery. To reduce this requirement to zero a sample size of 12 in each group would be required. As such, the aim is to enrol 44 patients to account for potential loss of follow-up and ensure the study is appropriately powered.
- Interventions: Patients in the treatment arm of the study will receive celecoxib 200 mg PO BID for 7 days and patients in the control arm will receive placebo PO BID for 7 days. Both medications are to be started on the evening of the day of surgery. Both groups will also be given a prescription for tramadol, an opioid medication, to be used as needed for breakthrough pain. Specifically, tramadol 50 mg PO Q6H PRN x 10 tablets will be prescribed. 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, all patients will be prescribed a nasal saline rinse which is to be started on postoperative day one.
- Randomization: Randomization will be via sequential random number generation from 1 to 40. Medications will be prepared by the hospital pharmacy and will be randomized in their preparation by the pharmacy. A master list will be kept in a sealed envelope by the PI in order to break blinding if an emergency occurs. Both study team members and patients will remain blinded to the group until after the study is completed.
- Being tested
- Celecoxib, Placebo
- Keywords
- Analgesia, Analgesic opioids, Nasal Polyposis, Treatment
- Medical subject headings
- Agnosia, Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called Celebrex
Patients will receive celecoxib 200 mg PO BID for 7 days post endoscopic sinus surgery, starting on the evening of the day of surgery.
PlaceboDrug
Patients will receive placebo PO BID for 7 days post endoscopic sinus surgery, starting on the evening of the day of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib Group | Experimental | 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. Receives: Drug: Celecoxib |
| Control Group | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post FESS changes in the Lund-Kennedy Endoscopic Score (LKES)
The postoperative recovery from FESS will be assessed via the changes in the Lund-Kennedy Endoscopic Score (LKES), measured on two time points throughout the post operative recovery.
Measured: 1 week and 4 weeks post-operatively.
Post FESS changes in the Peri-Operative Sinus Endoscopy (POSE) score
The postoperative recovery from FESS will be assessed via the changes in the Peri-Operative Sinus Endoscopy (POSE) score, measured on two time points throughout the post operative recovery.
Measured: 1 week and 4 weeks post-operatively.
Post FESS changes in the validated Sino-Nasal Outcome Test 22 (SNOT-22) questionnaire
The postoperative recovery from FESS will be assessed via the changes in the validated Sino-Nasal Outcome Test 22 (SNOT-22) questionnaire, measured on two time points throughout the post operative recovery.
Measured: 1 week and 4 weeks post-operatively.
Secondary outcomes (1)
Post FESS changes in the pain level assessed via the 10-point visual analogue scale
Daily assessment of postoperative pain level via the 10-point visual analogue scale, 6h after surgery, 24h after surgery, daily until day 7, and then at postoperative days 14 and 21.
Measured: 6h after surgery; 24 hours after surgery; 7 days post-surgery (daily); at the 14th day; and at the 21st day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start18 Feb 2020
- Primary completionFeb 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis with Nasal PolypsStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, double-blinded, randomized controlled study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Western University, Canada, London Health Sciences Centre
- Responsible party
- Sponsor
- Investigators
- Leigh Sowerby, MD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147013
- Sponsor's protocol ID
- 114809
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2019
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhattacharyya N. Incremental health care utilization and expenditures for chronic rhinosinusitis in the United States. Ann Otol Rhinol Laryngol. 2011 Jul;120(7):423-7. doi: 10.1177/000348941112000701.
PubMed 21859049Chen Y, Dales R, Lin M. The epidemiology of chronic rhinosinusitis in Canadians. Laryngoscope. 2003 Jul;113(7):1199-205. doi: 10.1097/00005537-200307000-00016.
PubMed 12838019Blackwell DL, Lucas JW, Clarke TC. Summary health statistics for U.S. adults: national health interview survey, 2012. Vital Health Stat 10. 2014 Feb;(260):1-161.
PubMed 24819891Xu Y, Quan H, Faris P, Garies S, Liu M, Bird C, Kukec E, Dean S, Rudmik L. Prevalence and Incidence of Diagnosed Chronic Rhinosinusitis in Alberta, Canada. JAMA Otolaryngol Head Neck Surg. 2016 Nov 1;142(11):1063-1069. doi: 10.1001/jamaoto.2016.2227.
PubMed 27606773Rudmik L, Smith TL, Schlosser RJ, Hwang PH, Mace JC, Soler ZM. Productivity costs in patients with refractory chronic rhinosinusitis. Laryngoscope. 2014 Sep;124(9):2007-12. doi: 10.1002/lary.24630. Epub 2014 Mar 11.
PubMed 24619604Church CA, Stewart C 4th, O-Lee TJ, Wallace D. Rofecoxib versus hydrocodone/acetaminophen for postoperative analgesia in functional endoscopic sinus surgery. Laryngoscope. 2006 Apr;116(4):602-6. doi: 10.1097/01.MLG.0000208341.30628.16.
PubMed 16585866Zhao H, Feng Y, Wang Y, Yang B, Xing Z. 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. Pain Med. 2011 Aug;12(8):1267-75. doi: 10.1111/j.1526-4637.2011.01196.x. Epub 2011 Aug 3.
PubMed 21812904Desrosiers M, Evans GA, Keith PK, Wright ED, Kaplan A, Bouchard J, Ciavarella A, Doyle PW, Javer AR, Leith ES, Mukherji A, Schellenberg RR, Small P, Witterick IJ. Canadian clinical practice guidelines for acute and chronic rhinosinusitis. Executive summary. J Otolaryngol Head Neck Surg. 2011 May;40 Suppl 2:S91-8. No abstract available.
PubMed 21658336Wright ED, Agrawal S. Impact of perioperative systemic steroids on surgical outcomes in patients with chronic rhinosinusitis with polyposis: evaluation with the novel Perioperative Sinus Endoscopy (POSE) scoring system. Laryngoscope. 2007 Nov;117(11 Pt 2 Suppl 115):1-28. doi: 10.1097/MLG.0b013e31814842f8.
PubMed 18075447
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Celecoxib on Postoperative Narcotic Use and Disease Severity in Patients with Aspirin-exacerbated Respiratory Disease and Chronic Rhinosinusitis: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04147013
- Acronym / sponsor ID
- 114809
- Keywords
- Analgesia, Analgesic opioids, Nasal Polyposis, Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Western University, Canada, London Health Sciences Centre
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
- Background: Chronic rhinosinusitis (CRS) affects up to 5% of Canadians and is associated with significant morbidity. It is characterized by inflammation of the mucosa of the nose and paranasal sinuses of at least 12 consecutive weeks' duration. Patients suffering from CRS are bothered on a daily basis by nasal obstruction, nasal discharge, facial pain, and an impaired sense of smell among other symptoms. Although not typically a life-threatening condition, CRS can drastically reduce a patient's quality of life as well as their workplace productivity. In fact, this has been demonstrated in the literature, with one study estimating the annual productivity cost of refractory CRS at about $10,000 per patient. Fortunately, effective management strategies are available. Mild to moderate disease can often be managed safely with long term use of topical glucocorticoids and nasal saline lavage. For more severe CRS unresponsive to appropriate medical therapy, oral glucocorticoids can be effective in the short term, but surgical treatment can help achieve long-term control of symptoms when initial medical therapy has failed. This is typically done via endoscopic sinus surgery (ESS), and its goal is to re-establish physiological patterns of ventilation and mucociliary clearance in patients with CRS, as well as establish access for topical therapy delivery. ESS is considered the gold standard of management for CRS and has proven to be highly effective in reducing the burden of inflammatory tissue and minimizing patient morbidity. Although developed as a minimally invasive technique to avoid the morbidity of open sinus surgery, ESS still entails some degree of surgical trauma, postoperative pain, and inflammation. Intraoperative local anesthetic infiltration is routinely performed but is insufficient to control pain in the immediate postoperative period. Patients often require some form of systemic analgesia and this usually consists of some combination of acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, and opioids. However, there is currently no consensus in the literature regarding the optimal analgesic regimen after ESS. Interestingly, in patients with aspirin-exacerbated respiratory disease (AERD) a triad of asthma, CRS, and aspirin (ASA/NSAID sensitivity), NSAIDs are classically associated with worsening of CRS symptoms. However, cyclooxygenase-2 (COX-2) inhibitors, a selective type of NSAID, have recently been studied as post-ESS analgesics and suggested as possible alternatives to opioids, which have many known potential adverse effects. These agents have also been studied for their anti-inflammatory properties in patients undergoing ESS and have been shown to decrease the levels of circulating prostaglandins in this population. Thus, AERD patients are a particularly important population in which to assess the effect of COX-2 inhibitors on post-operative pain and inflammation. This randomized, prospective study will evaluate both the anti-inflammatory and analgesic effects of a COX-2 inhibitor, celecoxib, in patients with AERD and CRS 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.
- The objectives of this study are: 1) to determine whether the addition of celecoxib to the FESS post-operative analgesia regimen can alter subjective and objective recovery from CRS signs and symptoms, and 2) to determine whether the addition of the COX-2 inhibitor, celecoxib, to the endoscopic sinus surgery post-operative analgesia regimen can reduce the amount of opioid narcotic used by patients for breakthrough pain.
- Trial Design: The study is a prospective, double-blinded, randomized controlled study and will be conducted at St. Joseph's Hospital in London, ON (CAN). There will be two study arms with 1:1 allocation, one arm will receive the study treatment and the other will receive a placebo;
- Sample Size Calculation: The initial pre-study sample size was calculated with 80% power at a significance level of 0.05. For the primary objective, previous studies have established that a 40% difference on the Lund-Kennedy Endoscopic Score would be clinically relevant. The statistical power was assumed to be 80%, and the needed significance level (2-tailed alpha error) was assumed to be 5%. Based on the literature, a mean difference of 3.4 and an SD of 2.6 for the Lund-Kennedy endoscopic reporting system was used for calculation, giving a sample size of 22. For the secondary objective, the sample size was calculated as follows. Assuming a difference of 2 of mean pain score (with a standard deviation of 2) on the Numeric Rating scale as significant, a sample size of 16 in each group is required. It has been reported elsewhere a total of 4.5 (+/-4.4) milligram morphine equivalent for patients undergoing a sinus surgery. To reduce this requirement to zero a sample size of 12 in each group would be required. As such, the aim is to enrol 44 patients to account for potential loss of follow-up and ensure the study is appropriately powered.
- Interventions: Patients in the treatment arm of the study will receive celecoxib 200 mg PO BID for 7 days and patients in the control arm will receive placebo PO BID for 7 days. Both medications are to be started on the evening of the day of surgery. Both groups will also be given a prescription for tramadol, an opioid medication, to be used as needed for breakthrough pain. Specifically, tramadol 50 mg PO Q6H PRN x 10 tablets will be prescribed. 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, all patients will be prescribed a nasal saline rinse which is to be started on postoperative day one.
- Randomization: Randomization will be via sequential random number generation from 1 to 40. Medications will be prepared by the hospital pharmacy and will be randomized in their preparation by the pharmacy. A master list will be kept in a sealed envelope by the PI in order to break blinding if an emergency occurs. Both study team members and patients will remain blinded to the group until after the study is completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A prospective, double-blinded, randomized controlled study.
| Arm | Type | Receives |
|---|---|---|
| Celecoxib Group | Experimental | Drug: CelecoxibPatients 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. |
| Control Group | Placebo comparator | Drug: PlaceboPatients 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18 years of age or older;
- 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;
- Capable, in the opinion of the primary investigator, of providing informed consent to participate in the study. Participants are required to sign an informed consent form indicating they understand the purpose and nature of the study, and that they are willing to participate.
Key exclusion criteria (23 listed)
- Known allergies/sensitivities to acetaminophen, opioid, or COX-2 inhibitor NSAIDs
- Inability to read and understand English
- Inability to keep record of exact use of analgesics post-FESS
- History of opioid/narcotic abuse
- Known Ischemic Heart Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CelecoxibAlso: CelebrexPatients will receive celecoxib 200 mg PO BID for 7 days post endoscopic sinus surgery, starting on the evening of the day of surgery. | Drug | Celecoxib Group |
| PlaceboPatients will receive placebo PO BID for 7 days post endoscopic sinus surgery, starting on the evening of the day of surgery. | Drug | Control Group |
Primary outcome
Post FESS changes in the Lund-Kennedy Endoscopic Score (LKES)
Time frame: 1 week and 4 weeks post-operatively.
The postoperative recovery from FESS will be assessed via the changes in the Lund-Kennedy Endoscopic Score (LKES), measured on two time points throughout the post operative recovery.
Post FESS changes in the Peri-Operative Sinus Endoscopy (POSE) score
Time frame: 1 week and 4 weeks post-operatively.
The postoperative recovery from FESS will be assessed via the changes in the Peri-Operative Sinus Endoscopy (POSE) score, measured on two time points throughout the post operative recovery.
Post FESS changes in the validated Sino-Nasal Outcome Test 22 (SNOT-22) questionnaire
Time frame: 1 week and 4 weeks post-operatively.
The postoperative recovery from FESS will be assessed via the changes in the validated Sino-Nasal Outcome Test 22 (SNOT-22) questionnaire, measured on two time points throughout the post operative recovery.
1 secondary outcome
Post FESS changes in the pain level assessed via the 10-point visual analogue scale
Time frame: 6h after surgery; 24 hours after surgery; 7 days post-surgery (daily); at the 14th day; and at the 21st day.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Background: PubMed 21859049Bhattacharyya N. Incremental health care utilization and expenditures for chronic rhinosinusitis in the United States. Ann Otol Rhinol Laryngol. 2011 Jul;120(7):423-7. doi: 10.1177/000348941112000701.
- Background: PubMed 12838019Chen Y, Dales R, Lin M. The epidemiology of chronic rhinosinusitis in Canadians. Laryngoscope. 2003 Jul;113(7):1199-205. doi: 10.1097/00005537-200307000-00016.
- Background: PubMed 24819891Blackwell DL, Lucas JW, Clarke TC. Summary health statistics for U.S. adults: national health interview survey, 2012. Vital Health Stat 10. 2014 Feb;(260):1-161.
- Background: PubMed 27606773Xu Y, Quan H, Faris P, Garies S, Liu M, Bird C, Kukec E, Dean S, Rudmik L. Prevalence and Incidence of Diagnosed Chronic Rhinosinusitis in Alberta, Canada. JAMA Otolaryngol Head Neck Surg. 2016 Nov 1;142(11):1063-1069. doi: 10.1001/jamaoto.2016.2227.
- Background: PubMed 24619604Rudmik L, Smith TL, Schlosser RJ, Hwang PH, Mace JC, Soler ZM. Productivity costs in patients with refractory chronic rhinosinusitis. Laryngoscope. 2014 Sep;124(9):2007-12. doi: 10.1002/lary.24630. Epub 2014 Mar 11.
- Background: PubMed 16585866Church CA, Stewart C 4th, O-Lee TJ, Wallace D. Rofecoxib versus hydrocodone/acetaminophen for postoperative analgesia in functional endoscopic sinus surgery. Laryngoscope. 2006 Apr;116(4):602-6. doi: 10.1097/01.MLG.0000208341.30628.16.
- Background: PubMed 21812904Zhao H, Feng Y, Wang Y, Yang B, Xing Z. 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. Pain Med. 2011 Aug;12(8):1267-75. doi: 10.1111/j.1526-4637.2011.01196.x. Epub 2011 Aug 3.
- Background: PubMed 21658336Desrosiers M, Evans GA, Keith PK, Wright ED, Kaplan A, Bouchard J, Ciavarella A, Doyle PW, Javer AR, Leith ES, Mukherji A, Schellenberg RR, Small P, Witterick IJ. Canadian clinical practice guidelines for acute and chronic rhinosinusitis. Executive summary. J Otolaryngol Head Neck Surg. 2011 May;40 Suppl 2:S91-8. No abstract available.
- Background: PubMed 18075447Wright ED, Agrawal S. Impact of perioperative systemic steroids on surgical outcomes in patients with chronic rhinosinusitis with polyposis: evaluation with the novel Perioperative Sinus Endoscopy (POSE) scoring system. Laryngoscope. 2007 Nov;117(11 Pt 2 Suppl 115):1-28. doi: 10.1097/MLG.0b013e31814842f8.
- Individual participant dataSharing planned: No
Related trials for Chronic Rhinosinusitis with Nasal Polyps
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Nasal Polyps
RecruitingPhase 3
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Recruiting
Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leigh Sowerby, MD principal investigator
Western University, Canada
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Celecoxib in people with Chronic Rhinosinusitis with Nasal Polyps and Aspirin-exacerbated Respiratory Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post FESS changes in the Lund-Kennedy Endoscopic Score (LKES) (time frame: 1 week and 4 weeks post-operatively.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04147013, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.