RhinosinusitisPhase 4NCT02582099
The Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis and Recurrent Sinusitis
A Phase 4 study testing Gentamicin nasal irrigation and Normal saline nasal irrigation in people with Rhinosinusitis, run by Mahidol University at 1 site in Thailand.
Trial summary
Topical antibiotic therapy in patients with refractory sinusitis has been shown to improve symptoms, quality of life, and mucosal aspect. In pediatrics allergy clinic at Siriraj hospital since 2006 use Gentamicin nasal irrigation for chronic rhinosinusitis.There have been no prospective studies in gentamicin… Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinosinusitis
- What is being tested?
- Gentamicin nasal irrigation and Normal saline nasal irrigation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2017to 30 Jun 2019
- 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 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 1. Chronic rhinosinusitis and/or recurrent acute/subacute sinusitis patients who were followed in pediatrics allergy clinic at Siriraj hospital between December 4, 2012, and December 3, 2016
Who cannot join
- Patients who used antibiotic prophylaxis within within 1 year before and 6 months after started gentamicin nasal irrigation
- Patients received IVIG within 1 year before and 6 months after started gentamicin nasal irrigation
- Patients received IT within 1 year before and 6 months after started gentamicin nasal irrigation
- Patients underwent endoscopic sinus surgery within 1 year before and 6 months after started gentamicin nasal irrigation
- Patient who have mental retardation
- Patient who have aminoglycosides hypersensitivity reactions
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- Pregnancy women and Lactation period
- Patient who have abnormal hearing test before started gentamicin nasal irrigation
- Patient who have chronic rhinosinusitis with nasal polyp
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, 10700
Nualanong Visitsunthorn, prof, (662)4197000 ext. 5941, sinvs@mahidol.ac.th
Nualanong Visitsunthorn, Prof
About this study
Official title: Comparison of the Efficacy and Complication of Gentamicin and Normal Saline Nasal Irrigation in Chronic Rhinosinusitis and Recurrent Sinusitis : a Double Blind Randomized Control Trial
Topical antibiotic therapy in patients with refractory sinusitis has been shown to improve symptoms, quality of life, and mucosal aspect. In pediatrics allergy clinic at Siriraj hospital since 2006 use Gentamicin nasal irrigation for chronic rhinosinusitis.There have been no prospective studies in gentamicin irrigation in chronic rhinosinusitis.
Read the detailed description
Chronic rhinosinusitis (CRS) is characterized by symptoms > 12 weeks.Two or more symptoms one of which should be either nasal blockage /obstruction/congestion or nasal discharge (anterior/posterior nasal drip): facial pain/pressure reduction or loss of smell).
Mainstay of treatment are medical and surgical treatment ( ATB, adenoidectomy, ESS) Adjunctive treatment : normal saline nasal irrigation, nasal corticosteroids, nasal decongestants, mucolytics. Nasal lavage with Mupirocin represent an effective and well tolerated alternative treatment of surgically recalcitrant chronic rhinosinusitis. Gentamicin irrigation should be helpful in chronic rhinosinusitis.
- Conditions
- Rhinosinusitis
- Being tested
- Gentamicin nasal irrigation, Normal saline nasal irrigation
- Medical subject headings
- Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentamicin nasal irrigationDrug
Nasal wash with gentamicin solution
Normal saline nasal irrigationDrug
Nasal wash with normal saline solution
| Study group | Role | What they receive |
|---|---|---|
| Gentamicin | Active comparator | Gentamicin nasal irrigation in chronic rhinosinusitis amount 20 ml each pernostril Receives: Drug: Gentamicin nasal irrigation |
| Normal saline | Placebo comparator | Normal saline nasal irrigation in chronic rhinosinusitis amount 20 ml each pernostril Receives: Drug: Normal saline nasal irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of sinusitis
Measured: During 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study start1 Jan 2017
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinosinusitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nualanong Visitsunthorn, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582099
- Sponsor's protocol ID
- 271/2555(EC1)
- Status last verified
- Aug 2018
- First submitted
- 20 Oct 2015
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Complication of Gentamicin and Normal Saline Nasal Irrigation in Chronic Rhinosinusitis and Recurrent Sinusitis : a Double Blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02582099
- Acronym / sponsor ID
- 271/2555(EC1)
- Conditions
- Rhinosinusitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 21 Oct 2015 (estimated)
- 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.
Topical antibiotic therapy in patients with refractory sinusitis has been shown to improve symptoms, quality of life, and mucosal aspect. In pediatrics allergy clinic at Siriraj hospital since 2006 use Gentamicin nasal irrigation for chronic rhinosinusitis.There have been no prospective studies in gentamicin irrigation in chronic rhinosinusitis.
Detailed description
Chronic rhinosinusitis (CRS) is characterized by symptoms > 12 weeks.Two or more symptoms one of which should be either nasal blockage /obstruction/congestion or nasal discharge (anterior/posterior nasal drip): facial pain/pressure reduction or loss of smell).
Mainstay of treatment are medical and surgical treatment ( ATB, adenoidectomy, ESS) Adjunctive treatment : normal saline nasal irrigation, nasal corticosteroids, nasal decongestants, mucolytics. Nasal lavage with Mupirocin represent an effective and well tolerated alternative treatment of surgically recalcitrant chronic rhinosinusitis. Gentamicin irrigation should be helpful in chronic rhinosinusitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gentamicin | Active comparator | Drug: Gentamicin nasal irrigationGentamicin nasal irrigation in chronic rhinosinusitis amount 20 ml each pernostril |
| Normal saline | Placebo comparator | Drug: Normal saline nasal irrigationNormal saline nasal irrigation in chronic rhinosinusitis amount 20 ml each pernostril |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 1. Chronic rhinosinusitis and/or recurrent acute/subacute sinusitis patients who were followed in pediatrics allergy clinic at Siriraj hospital between December 4, 2012, and December 3, 2016
Key exclusion criteria (9 listed)
- Patients who used antibiotic prophylaxis within within 1 year before and 6 months after started gentamicin nasal irrigation
- Patients received IVIG within 1 year before and 6 months after started gentamicin nasal irrigation
- Patients received IT within 1 year before and 6 months after started gentamicin nasal irrigation
- Patients underwent endoscopic sinus surgery within 1 year before and 6 months after started gentamicin nasal irrigation
- Patient who have mental retardation
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 |
|---|---|---|
| Gentamicin nasal irrigationNasal wash with gentamicin solution | Drug | Gentamicin |
| Normal saline nasal irrigationNasal wash with normal saline solution | Drug | Normal saline |
Primary outcome
Frequency of sinusitis
Time frame: During 1 year after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
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A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gentamicin nasal irrigation and Normal saline nasal irrigation in people with Rhinosinusitis, run by Mahidol University at 1 site in Thailand.
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 1 inclusion and 9 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 20 Aug 2018. 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 Thailand. 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?
Contact Nualanong Visitsunthorn, Professor (+6624195670, nualanongv@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of sinusitis (time frame: During 1 year after 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 20 Aug 2018.