Chronic Rhinosinusitis (Diagnosis), Nasal PolyposisPhase 3NCT03323866
Mometasone vs Budesonide in CRS With Polyposis
A Phase 3 study testing Budesonide 0.5 MG/ML and Mometasone nasal spray in people with Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
The principal objective is to compare the use of mometasone nasal spray to budesonide irrigations in patients suffering from CRSwNP who have never been operated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis
- What is being tested?
- Budesonide 0.5 MG/ML and Mometasone nasal spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2017to 1 Aug 2022
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic rhinosinusitis with nasal polyps
- Absence of active infection at start of study
Who cannot join
- Diagnosis of chronic rhinosinusitis without nasal polyps
- Diagnosis of recurrent acute bacterial rhinosinusitis
- Previous sinus surgery (septal of inferior turbinate surgeries are not considered sinus surgeries)
- Cystic fibrosis or ciliary dyskinesia
- Allergy to corticosteroids
- Pregnant or lactating women
- Contra-indication to intranasal steroids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controled Double-blinded Study Comparing Mometasone Nasal Spray to Budesonide Irrigations in Patients With Chronic Rhinosinusitis With Nasal Polyposis
The principal objective is to compare the use of mometasone nasal spray to budesonide irrigations in patients suffering from CRSwNP who have never been operated.
- Being tested
- Budesonide 0.5 MG/ML, Mometasone nasal spray
- Medical subject headings
- Disease, Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide 0.5 MG/MLDrug
2 cc nebule of budesonide in 240 cc of saline water (Sinus Rinse) once daily
Mometasone nasal sprayDrug
Mometasone 50 mcg/spray 2 sprays twice daily
| Study group | Role | What they receive |
|---|---|---|
| Mometasone nasal spray | Active comparator | Mometasone nasal spray 50 mcg/dose, 2 sprays/nostril twice daily x 3 months Patients will also be taking Sinus Rinse once daily throughout the study period Receives: Drug: Mometasone nasal spray |
| Budesonide irrigation | Experimental | 2 cc budesonide nebule (0,5 mg/cc) incorporated to 240 of saline water (Sinus Rinse) to be taken on a daily basis x 3 months Receives: Drug: Budesonide 0.5 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease specific quality of life questionnaire
SinoNasal Outcome Test - 22 This is a symptom score ranging from 0 to 110 points, 0 representing the absence of nasal symptoms and 110 being the most severe symptoms.
Measured: 3 months after beginning of treatment
Secondary outcomes (1)
Endoscopic evaluation of the nasal cavities
Lund Kennedy Endoscopic Score This is a score evaluating the healing of sinonasal cavities from 0 point (normal and healthy looking cavity) to 20 points (the most diseased cavity).
Measured: 3 months after beginning of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start1 May 2017
- Primary completion1 May 2022
- Study completion1 Aug 2022
Why it stopped: Difficulty with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis (Diagnosis), Nasal PolyposisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial comparing mometasone nasal spray to budesonide irrigations for treatment of chronic rhinosinusitis with nasal polyposis
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Bussières, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323866
- Sponsor's protocol ID
- 2017-1569
- Status last verified
- Sep 2022
- First submitted
- 24 Oct 2017
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controled Double-blinded Study Comparing Mometasone Nasal Spray to Budesonide Irrigations in Patients With Chronic Rhinosinusitis With Nasal Polyposis
- ClinicalTrials.gov ID
- NCT03323866
- Acronym / sponsor ID
- 2017-1569
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with recruitment
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 27 Oct 2017 (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.
The principal objective is to compare the use of mometasone nasal spray to budesonide irrigations in patients suffering from CRSwNP who have never been operated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial comparing mometasone nasal spray to budesonide irrigations for treatment of chronic rhinosinusitis with nasal polyposis
| Arm | Type | Receives |
|---|---|---|
| Mometasone nasal spray | Active comparator | Drug: Mometasone nasal sprayMometasone nasal spray 50 mcg/dose, 2 sprays/nostril twice daily x 3 months Patients will also be taking Sinus Rinse once daily throughout the study period |
| Budesonide irrigation | Experimental | Drug: Budesonide 0.5 MG/ML2 cc budesonide nebule (0,5 mg/cc) incorporated to 240 of saline water (Sinus Rinse) to be taken on a daily basis x 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of chronic rhinosinusitis with nasal polyps
- Absence of active infection at start of study
Key exclusion criteria (7 listed)
- Diagnosis of chronic rhinosinusitis without nasal polyps
- Diagnosis of recurrent acute bacterial rhinosinusitis
- Previous sinus surgery (septal of inferior turbinate surgeries are not considered sinus surgeries)
- Cystic fibrosis or ciliary dyskinesia
- Allergy to corticosteroids
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 |
|---|---|---|
| Budesonide 0.5 MG/ML2 cc nebule of budesonide in 240 cc of saline water (Sinus Rinse) once daily | Drug | Budesonide irrigation |
| Mometasone nasal sprayMometasone 50 mcg/spray 2 sprays twice daily | Drug | Mometasone nasal spray |
Primary outcome
Disease specific quality of life questionnaire
Time frame: 3 months after beginning of treatment
SinoNasal Outcome Test - 22 This is a symptom score ranging from 0 to 110 points, 0 representing the absence of nasal symptoms and 110 being the most severe symptoms.
1 secondary outcome
Endoscopic evaluation of the nasal cavities
Time frame: 3 months after beginning of treatment
Results and safety
The study was stopped early (reason given: Difficulty with recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
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CRSwNP, Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide 0.5 MG/ML and Mometasone nasal spray in people with Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis, run by Université de Sherbrooke at 1 site in Canada.
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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty with recruitment). 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?
Disease specific quality of life questionnaire (time frame: 3 months after beginning of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2022; AzTrials last refreshed its copy on 31 Oct 2026.