Sinusitis in ChildrenNCT06194097
Pediatric Chronic Rhinosinusitis in Asthmatic Children
A study testing adenoidectomy versus endoscopic sinus surgery with adenoidectomy in people with Sinusitis in Children, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
The objectives of this study would be to determine the most effective treatment for children with PCRS and asthma who fail medical management. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Sinusitis in Children
- What is being tested?
- adenoidectomy versus endoscopic sinus surgery with adenoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2017to 25 Jul 2020
- Phase
- Interventional
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 6-12 at time of study enrollment. Presence of chronic sinusitis: >90 days 2 or more symptoms of purulent rhinorrhea, nasal obstruction, facial pressure/pain, or cough with corresponding endoscopic and/or CT findings in a patient 18 years or younger.
- Presence of asthma, as documented in the medical record by the patient's pediatrician and/or pulmonologist
Who cannot join
- Exclusion criteria include previous sinus surgery, previous adenoidectomy, or presence of cystic fibrosis, antrochoanal polyp, immunodeficiency, or fungal infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical Center
Syracuse, New York, 13210
About this study
Official title: Management of Pediatric Chronic Rhinosinusitis in Asthmatic Children
The objectives of this study would be to determine the most effective treatment for children with PCRS and asthma who fail medical management.
Read the detailed description
This prospective, randomized study would involve children age 6-12 with symptoms of both PCRS and asthma. Their symptoms would first be managed medically with standard medical therapy. In the event they fail medical management, patients would then be randomized to two treatment arms, either adenoidectomy alone or adenoidectomy with ESS. CT scan of the sinuses would then be obtained to evaluate the extent of sinus disease and aid in preoperative planning in those patients undergoing ESS. Sinus mucosa thickening seen on CT is also integral in the diagnosis of PCRS, according to consensus statements published by the American Academy of Otolaryngology. At each visit patient's symptoms would be measured with the SN-5, a validated questionnaire for tracking PCRS.
- Conditions
- Sinusitis in Children
- Being tested
- adenoidectomy versus endoscopic sinus surgery with adenoidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adenoidectomy versus endoscopic sinus surgery with adenoidectomyProcedure or surgery
adenoidectomy versus endoscopic sinus surgery
| Study group | Role | What they receive |
|---|---|---|
| Adenoidectomy | Experimental | Not described Receives: Procedure: adenoidectomy versus endoscopic sinus surgery with adenoidectomy |
| Endoscopic Sinus surgery and Adenoidectomy | Experimental | Not described Receives: Procedure: adenoidectomy versus endoscopic sinus surgery with adenoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical outcome
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start25 Jul 2017
- Primary completion25 Jul 2020
- Study completion25 Jul 2020
Why it stopped: poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinusitis in ChildrenStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194097
- Sponsor's protocol ID
- 1009628-5
- Status last verified
- Apr 2021
- First submitted
- 1 Nov 2017
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Pediatric Chronic Rhinosinusitis in Asthmatic Children
- ClinicalTrials.gov ID
- NCT06194097
- Acronym / sponsor ID
- 1009628-5
- Conditions
- Sinusitis in Children
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: poor recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 25 Jul 2020 (actual)
- Study completion
- 25 Jul 2020 (actual)
- First posted
- 8 Jan 2024 (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 objectives of this study would be to determine the most effective treatment for children with PCRS and asthma who fail medical management.
Detailed description
This prospective, randomized study would involve children age 6-12 with symptoms of both PCRS and asthma. Their symptoms would first be managed medically with standard medical therapy. In the event they fail medical management, patients would then be randomized to two treatment arms, either adenoidectomy alone or adenoidectomy with ESS. CT scan of the sinuses would then be obtained to evaluate the extent of sinus disease and aid in preoperative planning in those patients undergoing ESS. Sinus mucosa thickening seen on CT is also integral in the diagnosis of PCRS, according to consensus statements published by the American Academy of Otolaryngology. At each visit patient's symptoms would be measured with the SN-5, a validated questionnaire for tracking PCRS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Adenoidectomy | Experimental | Procedure: adenoidectomy versus endoscopic sinus surgery with adenoidectomy |
| Endoscopic Sinus surgery and Adenoidectomy | Experimental | Procedure: adenoidectomy versus endoscopic sinus surgery with adenoidectomy |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 6-12 at time of study enrollment. Presence of chronic sinusitis: >90 days 2 or more symptoms of purulent rhinorrhea, nasal obstruction, facial pressure/pain, or cough with corresponding endoscopic and/or CT findings in a patient 18 years or younger.
- Presence of asthma, as documented in the medical record by the patient's pediatrician and/or pulmonologist
Key exclusion criteria (1 listed)
- Exclusion criteria include previous sinus surgery, previous adenoidectomy, or presence of cystic fibrosis, antrochoanal polyp, immunodeficiency, or fungal infection.
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 |
|---|---|---|
| adenoidectomy versus endoscopic sinus surgery with adenoidectomyadenoidectomy versus endoscopic sinus surgery | Procedure or surgery | Adenoidectomy, Endoscopic Sinus surgery and Adenoidectomy |
Primary outcome
surgical outcome
Time frame: 1 year
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 8 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Sinusitis in Children
RecruitingPhase 4
Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Sinusitis)
ACUTE SINUSITIS, Sinusitis
Not yet recruitingObservational study
Observational Study of RHINOSEDAL in Acute Nasal Obstruction
Nasal Obstruction, Common Cold
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 study testing adenoidectomy versus endoscopic sinus surgery with adenoidectomy in people with Sinusitis in Children, run by State University of New York - Upstate Medical 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 1 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 8 Jan 2024. 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.
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?
surgical outcome (time frame: 1 year). 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 8 Jan 2024.