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Management of Pediatric Chronic Rhinosinusitis in Asthmatic Children

This study is currently recruiting participants.
Verified November 2017 by State University of New York - Upstate Medical University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03336671
First Posted: November 8, 2017
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
State University of New York - Upstate Medical University
  Purpose
The objectives of this study would be to determine the most effective management for pediatric patients with chronic rhinosinusitis and asthma who fail medical management. Kay in 2003 published the SN-5, a validated tool used to track symptoms of pediatric chronic rhinosinusitis. A decrease in at least 0.5 is felt to represent an improvement in symptom control. In this study, the SN-5 at one year post intervention will be the primary endpoint. Secondary endpoints include complications, revision surgery, and post operative endoscopy scores.

Condition Intervention
Chronic Sinusitis Adenoid Disease - Chronic Procedure: Adenoidectomy plus Endoscopic Sinus surgery Procedure: Adenoidectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective Randomized Controlled Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Management of Pediatric Chronic Rhinosinusitis in Asthmatic Children

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • SN-5 at one year post procedure [ Time Frame: One year ]
    A validated tool used to track symptoms of pediatric chronic rhinosinusitis, improvement greater than 0.5


Secondary Outcome Measures:
  • Revision/Alternate procedure, endoscopic sinus surgery [ Time Frame: Two Years ]
    Requirement of the alternate procedure or a revision procedure.

  • Antibiotic use after surgical procedure [ Time Frame: Two years ]
    Relapse of chronic rhinosinusitis, if treated with antibiotics will be documented as the number of courses of antibiotics taken for rhino sinusitis in two years after the initial procedure

  • Complication Rate [ Time Frame: Two Years ]
    Complications associated with medical management, or surgery


Estimated Enrollment: 60
Actual Study Start Date: July 1, 2017
Estimated Study Completion Date: July 1, 2020
Estimated Primary Completion Date: July 1, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Adenoidectomy
Current standard of care for pediatric chronic rhino sinusitis.
Procedure: Adenoidectomy
Adenoidectomy performed, routine, as a singular procedure not combined with any sinus surgery.
Experimental: Adenoidectomy plus Endoscopic Sinus Surgery
endoscopic sinus surgery in addition to adenoidectomy
Procedure: Adenoidectomy plus Endoscopic Sinus surgery
Endoscopic sinus surgery would be tailored to abnormal findings in the CT scan, as is the standard of care. Radiologists typically examine sinonasal disease of the sinuses, and they would also be requested to comment on the patency of the osteo-meatal unit, as this is a component of the Lund-McKay score. The Lund-McKay score is an objective radiologic grade of the severity of sinusitis. If there is sinus thickening, or narrowing of the OMU, endoscopic sinus surgery would be tailored to this using either balloon sinuplasty or traditional antrostomy. Patient undergoing endoscopic sinus surgery will likely have at least a maxillary antrostomy and anterior ethmoidectomy performed, with frontal sinusotomy, posterior ethmoidectomy, and sphenoidotomy performed depending on CT or endoscopy findings.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 6-12 at time of study enrollment.
  2. Presence of chronic sinusitis: >90 days 2 or more symptoms of purulent rhinorrhea, nasal obstruction, facial pressure/pain, or cough
  3. Presence of asthma, as documented in the medical record by the patient's pediatrician and/or pulmonologist
  4. Failure of medical management of PCRS, which current guidelines recommend extended empiric antibiotics for 21 days, which will be either Augmentin or clindamycin in penicillin allergic patients, at standard pediatric weight based dosing. In addition, Flonase nasal spray and nasal saline treatment for three weeks. Failure is considered persistent symptoms despite treatment with the above within the past year.

Exclusion Criteria:

  1. Previous sinus surgery,
  2. Previous adenoidectomy, or
  3. Presence of cystic fibrosis,
  4. Presence of antrochoanal polyp,
  5. Immunodeficiency
  6. Fungal infection.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03336671


Contacts
Contact: Mark Arnold, MD 651 206-2850 Arnoldm@upstate.edu
Contact: Haidy Marzouk, MD 315 464-4678 MarzoukH@Upstate.edu

Locations
United States, New York
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13202
Contact: Mark Arnold, MD    651-206-2850    Arnoldm@Upstate.edu   
Contact: Haidy Marzouk, MD    315 464-4678    MarzoukH@Upstate.edu   
Principal Investigator: Haidy Marzouk, MD         
Sub-Investigator: Mark Arnold, MD         
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: Haidy Marzouk, MD State University of New York - Upstate Medical University
Study Director: Mark Arnold, MD 315 464-4678
  More Information

Responsible Party: State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT03336671     History of Changes
Other Study ID Numbers: 1009628
First Submitted: November 1, 2017
First Posted: November 8, 2017
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by State University of New York - Upstate Medical University:
Pediatric
Chronic Sinusitis

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes