Chronic Sinus InfectionPhase 2/3NCT03519061
Impact of Budesonide Irrigations on Patients With Chronic Rhinosinusitis and Impact on Sinus Surgery Rates
A Phase 2/3 study testing Budesonide in people with Chronic Sinus Infection and Chronic Sinusitis, run by Kaiser Permanente at 1 site in United States.
Trial summary
This study is intended to assess the impact of a 90 day course of high volume budesonide irrigations for patients who have failed other medical therapy and assessing the impact of the budesonide irrigations on the need for sinus surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Sinus Infection, Chronic Sinusitis, Chronic Sinusitis - Ethmoidal, Posterior
- What is being tested?
- Budesonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2019to 1 Oct 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult (>18 yo)
- symptoms consistent with sinusitis for at least 12 weeks,
- undergone maximal medical therapy, including: extended course of antibiotics (21 days minimum), use of topical corticosteroids for a minimum of 6 weeks, use of saline rinses at least once a day for a minimum of 3 weeks
- CT showing evidence of chronic sinusitis.
Who cannot join
- pregnant women,
- age below 18,
- presence of nasal polyps or other nasal masses,
- failure to complete medical therapy,
- normal CT scan,
- intolerance to budesonide or saline irrigations via squeeze bottle (high volume, high flow).
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanante Orange County
Irvine, California, 92816
About this study
This study is intended to assess the impact of a 90 day course of high volume budesonide irrigations for patients who have failed other medical therapy and assessing the impact of the budesonide irrigations on the need for sinus surgery.
Read the detailed description
Patient who meet eligibility requirements will be given the opportunity to use a budesonide saline rinse twice daily for 90 days. At the completion of this therapy, their clinical situation will be reassessed and patients will either proceed to surgery or not. If eligible patients choose not participate, they will be offered surgery up front. The study will be assessing symptom scores using the SNOT-22 validated patient reported symptoms score, CT scans, and other measures. The study hypothesizes that a significant portion of patients that otherwise would have progressed to surgery will no longer need to have surgery based upon improvements in their overall symptoms scores after using budesonise irrigations.
- Conditions
- Chronic Sinus Infection, Chronic Sinusitis, Chronic Sinusitis - Ethmoidal, Posterior, Chronic Sinus Congestion
- Being tested
- Budesonide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
Nasal saline irrigations with budesonide
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | This is the group of enrollees who receive budesonide Receives: Drug: Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
SinoNasal Outcome Test (SNOT 22)
Improvement in SNOT 22 scores, using a total score value. The total score can range from 0 to 110 in its composite score, with higher values indicating worse symptoms. The outcome would measure improvements beyond the Minimal Clinically Important Difference (MCID) score of 8.9 lower (lower indicating improvement of symptoms).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start13 Aug 2019 (estimated)
- Primary completion30 Aug 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Why it stopped: Unable to obtain FDA exemption
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Sinus InfectionStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Non randomized, single arm, prospective
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519061
- Sponsor's protocol ID
- Budesonide SInus Irrigations
- Other IDs
- 000001
- Status last verified
- Jan 2021
- First submitted
- 26 Apr 2018
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Budesonide Irrigations on Patients With Chronic Rhinosinusitis and Impact on Sinus Surgery Rates
- ClinicalTrials.gov ID
- NCT03519061
- Acronym / sponsor ID
- Budesonide SInus Irrigations
- Conditions
- Chronic Sinus Infection, Chronic Sinusitis, Chronic Sinusitis - Ethmoidal, Posterior, Chronic Sinus Congestion
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to obtain FDA exemption
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 13 Aug 2019 (estimated)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 8 May 2018 (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 study is intended to assess the impact of a 90 day course of high volume budesonide irrigations for patients who have failed other medical therapy and assessing the impact of the budesonide irrigations on the need for sinus surgery.
Detailed description
Patient who meet eligibility requirements will be given the opportunity to use a budesonide saline rinse twice daily for 90 days. At the completion of this therapy, their clinical situation will be reassessed and patients will either proceed to surgery or not. If eligible patients choose not participate, they will be offered surgery up front. The study will be assessing symptom scores using the SNOT-22 validated patient reported symptoms score, CT scans, and other measures. The study hypothesizes that a significant portion of patients that otherwise would have progressed to surgery will no longer need to have surgery based upon improvements in their overall symptoms scores after using budesonise irrigations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non randomized, single arm, prospective
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: BudesonideThis is the group of enrollees who receive budesonide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult (>18 yo)
- symptoms consistent with sinusitis for at least 12 weeks,
- undergone maximal medical therapy, including: extended course of antibiotics (21 days minimum), use of topical corticosteroids for a minimum of 6 weeks, use of saline rinses at least once a day for a minimum of 3 weeks
- CT showing evidence of chronic sinusitis.
Key exclusion criteria (6 listed)
- pregnant women,
- age below 18,
- presence of nasal polyps or other nasal masses,
- failure to complete medical therapy,
- normal CT scan,
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 |
|---|---|---|
| BudesonideNasal saline irrigations with budesonide | Drug | Treatment |
Primary outcome
SinoNasal Outcome Test (SNOT 22)
Time frame: 12 months
Improvement in SNOT 22 scores, using a total score value. The total score can range from 0 to 110 in its composite score, with higher values indicating worse symptoms. The outcome would measure improvements beyond the Minimal Clinically Important Difference (MCID) score of 8.9 lower (lower indicating improvement of symptoms).
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 14 Jan 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.
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 2/3 study testing Budesonide in people with Chronic Sinus Infection and Chronic Sinusitis, run by Kaiser Permanente 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 4 inclusion and 6 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 14 Jan 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?
SinoNasal Outcome Test (SNOT 22) (time frame: 12 months). 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 14 Jan 2021.