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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
American Rhinologic Society
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT01197612
First received: August 30, 2010
Last updated: September 8, 2010
Last verified: August 2010
  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: 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 University of Michigan:

Primary Outcome Measures:
  • olfaction [ Time Frame: 3 weeks post-op ] [ Designated as safety issue: No ]
    will be measured with the University of Pennsylvania Smell Identification Test (UPSIT)


Secondary Outcome Measures:
  • Sinonasal health [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    will be assessed with the Perioperative Sinus Endoscopy score (POSE)

  • Olfaction [ Time Frame: 24 weeks post-op ] [ Designated as safety issue: No ]
    Scored with the University of Pennsylvania Smell Identification Test

  • Sinonasal health [ Time Frame: 24 weeks post-op ] [ Designated as safety issue: No ]
    Assessed with Perioperative Sinus Endoscopy (POSE) score


Study Start Date: September 2010
Arms Assigned Interventions
all subjects
each subject serves as their own control
Drug: pulmicort
applied to nasal packing after surgery
Other Names:
  • pulmicort
  • budesonide

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 f/u appt's
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197612

Contacts
Contact: Garrett R Griffin, MD 703-628-6424 gargriff@med.umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48103
Contact: University of Michigan    734-936-4000      
Sub-Investigator: Melissa Pynnonen, MD         
Sub-Investigator: Jeff Terrell, MD         
Sponsors and Collaborators
University of Michigan
American Rhinologic Society
Investigators
Principal Investigator: Garrett R Griffin, MD University of Michigan
  More Information

No publications provided

Responsible Party: Garrett Griffin, University of Michigan Department of Otolaryngology
ClinicalTrials.gov Identifier: NCT01197612     History of Changes
Other Study ID Numbers: HUM00029273
Study First Received: August 30, 2010
Last Updated: September 8, 2010
Health Authority: United States: Institutional Review Board
United States: American Rhinologic Society

Additional relevant MeSH terms:
Sinusitis
Nose Diseases
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Budesonide
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014