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Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01197612
First Posted: September 9, 2010
Last Update Posted: September 12, 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. Read our disclaimer for details.
Collaborator:
American Rhinologic Society
Information provided by (Responsible Party):
Garrett Griffin, University of Michigan
  Purpose
That high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery.

Condition Intervention Phase
Chronic Sinusitis Polyposis Drug: pulmicort Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis

Resource links provided by NLM:


Further study details as provided by Garrett Griffin, University of Michigan:

Primary Outcome Measures:
  • olfaction [ Time Frame: 3 weeks post-op ]
    will be measured with the University of Pennsylvania Smell Identification Test (UPSIT)


Secondary Outcome Measures:
  • Sinonasal health [ Time Frame: 3 weeks ]
    will be assessed with the Perioperative Sinus Endoscopy score (POSE)

  • Olfaction [ Time Frame: 24 weeks post-op ]
    Scored with the University of Pennsylvania Smell Identification Test

  • Sinonasal health [ Time Frame: 24 weeks post-op ]
    Assessed with Perioperative Sinus Endoscopy (POSE) score


Enrollment: 23
Actual Study Start Date: September 2010
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm; nostrils as experimental and comparator
each subject serves as their own control with one nostril being treated with pulmicort and one not
Drug: pulmicort
applied to nasal packing after surgery
Other Name: budesonide

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hyposmia and nasal obstruction for >12 weeks
  • bilateral nasal polyposis
  • candidate for surgery

Exclusion Criteria:

  • immunocompromised
  • non-English speaking
  • prisoner
  • pregnant/lactating
  • will not attend follow up appointments
  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): NCT01197612


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48103
Sponsors and Collaborators
University of Michigan
American Rhinologic Society
Investigators
Principal Investigator: Garrett R Griffin, MD University of Michigan
  More Information

Responsible Party: Garrett Griffin, Resident/Research Fellow, University of Michigan
ClinicalTrials.gov Identifier: NCT01197612     History of Changes
Other Study ID Numbers: HUM00029273
First Submitted: August 30, 2010
First Posted: September 9, 2010
Last Update Posted: September 12, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Sinusitis
Colorectal Neoplasms
Nasopharyngeal Neoplasms
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Disease Attributes
Pathologic Processes
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents