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

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ClinicalTrials.gov Identifier: NCT01197612
Recruitment Status : Completed
First Posted : September 9, 2010
Results First Posted : May 29, 2018
Last Update Posted : May 29, 2018
Sponsor:
Collaborator:
American Rhinologic Society
Information provided by (Responsible Party):
Garrett Griffin, University of Michigan

Study Description
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Brief Summary:
That high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery.

Condition or disease Intervention/treatment Phase
Chronic Sinusitis Polyposis Drug: pulmicort Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
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
Actual Study Start Date : September 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
Drug Information available for: Budesonide

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Olfaction [ Time Frame: 3 weeks post-operation ]
    will be measured with the University of Pennsylvania Smell Identification Test (UPSIT), whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification


Secondary Outcome Measures :
  1. Sinonasal Health [ Time Frame: 3 weeks post operation ]
    will be assessed with the Perioperative Sinus Endoscopy score (POSE), a 20 point scale where 0 is no sinus challenges and 20 represents the greatest blockage.

  2. Olfaction [ Time Frame: 24 weeks post operation ]
    Scored with the University of Pennsylvania Smell Identification Test, whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification

  3. Sinonasal Health [ Time Frame: 24 weeks post operation ]
    Assessed with Perioperative Sinus Endoscopy (POSE) score


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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
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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
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48103
Sponsors and Collaborators
University of Michigan
American Rhinologic Society
Investigators
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Principal Investigator: Garrett R Griffin, MD University of Michigan
More Information
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Responsible Party: Garrett Griffin, Resident/Research Fellow, University of Michigan
ClinicalTrials.gov Identifier: NCT01197612    
Other Study ID Numbers: HUM00029273
First Posted: September 9, 2010    Key Record Dates
Results First Posted: May 29, 2018
Last Update Posted: May 29, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Sinusitis
Colorectal Neoplasms
Nasopharyngeal Neoplasms
Chronic Disease
Respiratory Tract Infections
Infections
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
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