Chronic Rhinosinusitis (Diagnosis)Phase 2/3NCT04242368
Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis
A Phase 2/3 study testing Isotonic saline, Hypertonic Nasal Wash and Fluticasone Propionate in people with Chronic Rhinosinusitis (Diagnosis), run by Stanford University at 1 site in United States.
Trial summary
The study aims to determine the safety and efficacy of buffered hypertonic (1.8%) saline nasal rinses as compared to isotonic saline nasal rinses in patients with chronic rhinosinusitis (CRS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- Isotonic saline, Hypertonic Nasal Wash and Fluticasone Propionate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 1 Jul 2021
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic rhinosinusitis with or without polyposis based on the criteria outlined in the American Academy of Otolaryngology-Head and Neck Surgery's Clinical Practice Guideline
- SNOT-22 score >/= 20
Who cannot join
- Sinus surgery within 30 days of beginning the study
- Oral steroid use within two weeks of study initiation
- Active sinus exacerbation or sinus exacerbation within two weeks of starting the study
- Allergies or contraindications to fluticasone nasal spray
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to determine the safety and efficacy of buffered hypertonic (1.8%) saline nasal rinses as compared to isotonic saline nasal rinses in patients with chronic rhinosinusitis (CRS). Evidence from basic science research suggests that hypertonic solutions may have beneficial effects over isotonic saline rinses; however prior clinical studies on this topic have been inconclusive and limited due to highly variable inclusion criteria, large variability in the volume and concentration of irrigation solution, and inconsistent outcome measures. The goal of the study is to utilize a cross over study design to directly compare the impact of two different types of saline irrigation.
Primary aim:
Read more
Compare the efficacy of buffered hypertonic saline irrigations to buffered isotonic saline irrigations on patient reported outcome measures of chronic rhinosinusitis symptoms and nasal obstruction in patients with CRS. Based on in vivo data and prior clinical studies, the investigators expect participants will experience greater symptom improvement with hypertonic saline rinses as compared to isotonic saline irrigations.
Hypothesis: Participants will have greater improvement in patient reported outcome measures (SNOT-22 and NOSE) when using buffered hypertonic sinus irrigations as compared to buffered isotonic saline irrigations.
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Being tested
- Isotonic saline, Hypertonic Nasal Wash, Fluticasone Propionate
- Keywords
- chronic rhinosinusitis, nasal rinses, nasal irrigations
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isotonic salineDrug
Nasal isotonic saline irrigation (240 mL, 0.9% NaCl) administered through nasal rinse bottle.
Hypertonic Nasal WashDrug
Nasal hypertonic saline irrigation (240 mL, 1.8% NaCl) administered through nasal rinse bottle.
Fluticasone PropionateDrug
Also called Flonase
Fluticasone nasal spray administered two sprays to each nare twice a day
| Study group | Role | What they receive |
|---|---|---|
| Isotonic rinse, then hypertonic rinse | Active comparator | Participants will start with a one week washout period without rinses. Then they will complete twice daily sinus rinses isotonic saline for two weeks. Next they will have a one week washout period without rinses. Then they will cross-over and complete hypertonic saline sinus rinses for two weeks. Participants will maintain fluticasone treatment throughout the study. Receives: Drug: Isotonic saline; Drug: Hypertonic Nasal Wash; Drug: Fluticasone Propionate |
| Hypertonic rinse, then isotonic rinse | Experimental | Participants will start with a one week washout period without rinses. Then they will complete twice daily sinus rinses of hypertonic saline for two weeks. Next they will have a one week washout period without rinses. Then they will cross-over and complete isotonic saline sinus rinses for two weeks. Participants will maintain fluticasone treatment throughout the study.
Fluticasone propionate nasal spray - two sprays to each nare twice a day used for the entire study duration Receives: Drug: Isotonic saline; Drug: Hypertonic Nasal Wash; Drug: Fluticasone Propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in SNOT-22 score
Participants will complete the Sinonasal Outcome Test (SNOT)-22, a validated questionnaire for assessing symptoms of chronic rhinosinusitis, before and after completing each intervention.
SNOT-22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients.
Measured: Beginning of week 2 and end of week 3 of the respective treatment period
Mean change in NOSE score
Participants will complete the Nasal Obstruction Symptom Evaluation (NOSE), a validated questionnaire for assessing symptoms of nasal obstruction, before and after completing each intervention.
NOSE scores can range from 5 to 100, with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75), and severe (80-100).
Measured: Beginning of week 2 and end of week 3 of the respective treatment period
Secondary outcomes (1)
Participant-reported compliance with sinus rinses
Participants will self-report the number of days in the two week rinsing period in which they used rinses.
Measured: From the beginning of week 2 to the end of week 3 of the respective treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Jul 2020 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Why it stopped: COVID-19 pandemic, unable to recruit and conduct study procedures per state, local, and university policies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neelaysh Vukkadala, Stanford University
- Investigators
- Neelaysh Vukkadala, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242368
- Sponsor's protocol ID
- IRB-53836
- Status last verified
- Mar 2021
- First submitted
- 21 Jan 2020
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT04242368
- Acronym / sponsor ID
- IRB-53836
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Keywords
- chronic rhinosinusitis, nasal rinses, nasal irrigations
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 pandemic, unable to recruit and conduct study procedures per state, local, and university policies.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 27 Jan 2020 (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 study aims to determine the safety and efficacy of buffered hypertonic (1.8%) saline nasal rinses as compared to isotonic saline nasal rinses in patients with chronic rhinosinusitis (CRS). Evidence from basic science research suggests that hypertonic solutions may have beneficial effects over isotonic saline rinses; however prior clinical studies on this topic have been inconclusive and limited due to highly variable inclusion criteria, large variability in the volume and concentration of irrigation solution, and inconsistent outcome measures. The goal of the study is to utilize a cross over study design to directly compare the impact of two different types of saline irrigation.
Primary aim:
Compare the efficacy of buffered hypertonic saline irrigations to buffered isotonic saline irrigations on patient reported outcome measures of chronic rhinosinusitis symptoms and nasal obstruction in patients with CRS. Based on in vivo data and prior clinical studies, the investigators expect participants will experience greater symptom improvement with hypertonic saline rinses as compared to isotonic saline irrigations.
Hypothesis: Participants will have greater improvement in patient reported outcome measures (SNOT-22 and NOSE) when using buffered hypertonic sinus irrigations as compared to buffered isotonic saline irrigations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isotonic rinse, then hypertonic rinse | Active comparator | Drug: Isotonic saline, Drug: Hypertonic Nasal Wash, Drug: Fluticasone PropionateParticipants will start with a one week washout period without rinses. Then they will complete twice daily sinus rinses isotonic saline for two weeks. Next they will have a one week washout period without rinses. Then they will cross-over and complete hypertonic saline sinus rinses for two weeks. Participants will maintain fluticasone treatment throughout the study. |
| Hypertonic rinse, then isotonic rinse | Experimental | Drug: Isotonic saline, Drug: Hypertonic Nasal Wash, Drug: Fluticasone PropionateParticipants will start with a one week washout period without rinses. Then they will complete twice daily sinus rinses of hypertonic saline for two weeks. Next they will have a one week washout period without rinses. Then they will cross-over and complete isotonic saline sinus rinses for two weeks. Participants will maintain fluticasone treatment throughout the study. Fluticasone propionate nasal spray - two sprays to each nare twice a day used for the entire study duration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of chronic rhinosinusitis with or without polyposis based on the criteria outlined in the American Academy of Otolaryngology-Head and Neck Surgery's Clinical Practice Guideline
- SNOT-22 score >/= 20
Key exclusion criteria (4 listed)
- Sinus surgery within 30 days of beginning the study
- Oral steroid use within two weeks of study initiation
- Active sinus exacerbation or sinus exacerbation within two weeks of starting the study
- Allergies or contraindications to fluticasone nasal spray
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 |
|---|---|---|
| Isotonic salineNasal isotonic saline irrigation (240 mL, 0.9% NaCl) administered through nasal rinse bottle. | Drug | Hypertonic rinse, then isotonic rinse, Isotonic rinse, then hypertonic rinse |
| Hypertonic Nasal WashNasal hypertonic saline irrigation (240 mL, 1.8% NaCl) administered through nasal rinse bottle. | Drug | Hypertonic rinse, then isotonic rinse, Isotonic rinse, then hypertonic rinse |
| Fluticasone PropionateAlso: FlonaseFluticasone nasal spray administered two sprays to each nare twice a day | Drug | Hypertonic rinse, then isotonic rinse, Isotonic rinse, then hypertonic rinse |
Primary outcome
Mean change in SNOT-22 score
Time frame: Beginning of week 2 and end of week 3 of the respective treatment period
Participants will complete the Sinonasal Outcome Test (SNOT)-22, a validated questionnaire for assessing symptoms of chronic rhinosinusitis, before and after completing each intervention. SNOT-22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients.
Mean change in NOSE score
Time frame: Beginning of week 2 and end of week 3 of the respective treatment period
Participants will complete the Nasal Obstruction Symptom Evaluation (NOSE), a validated questionnaire for assessing symptoms of nasal obstruction, before and after completing each intervention. NOSE scores can range from 5 to 100, with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75), and severe (80-100).
1 secondary outcome
Participant-reported compliance with sinus rinses
Time frame: From the beginning of week 2 to the end of week 3 of the respective treatment period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Neelaysh Vukkadala, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Isotonic saline, Hypertonic Nasal Wash and Fluticasone Propionate in people with Chronic Rhinosinusitis (Diagnosis), run by Stanford University at 1 site in United States.
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 4 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: withdrawn, as of the sponsor's last update on 18 Mar 2021. 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 United States. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Mean change in SNOT-22 score (time frame: Beginning of week 2 and end of week 3 of the respective treatment period). The study lists 2 primary outcomes in all. 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 18 Mar 2021.