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

This study has been completed.
American Rhinologic Society
Information provided by (Responsible Party):
Garrett Griffin, University of Michigan Identifier:
First received: August 30, 2010
Last updated: September 8, 2017
Last verified: September 2017
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


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

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
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Please refer to this study by its identifier: NCT01197612

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

Responsible Party: Garrett Griffin, Resident/Research Fellow, University of Michigan Identifier: NCT01197612     History of Changes
Other Study ID Numbers: HUM00029273
Study First Received: August 30, 2010
Last Updated: September 8, 2017

Additional relevant MeSH terms:
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
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
Anti-Inflammatory Agents
Bronchodilator Agents processed this record on September 21, 2017