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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. The completion date has passed and the status has not been verified in more than two years.
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

August 30, 2010
September 8, 2010
September 2010
Not Provided
olfaction [ Time Frame: 3 weeks post-op ] [ Designated as safety issue: No ]
will be measured with the University of Pennsylvania Smell Identification Test (UPSIT)
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis
Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis
That high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery.
Not Provided
Interventional
Phase 3
Primary Purpose: Treatment
  • Chronic
  • Sinusitis
  • Polyposis
Drug: pulmicort
applied to nasal packing after surgery
Other Name: budesonide
all subjects
each subject serves as their own control
Intervention: Drug: pulmicort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
Not Provided
Not Provided
Not Provided

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01197612
HUM00029273
Yes
Not Provided
Not Provided
Garrett Griffin, University of Michigan Department of Otolaryngology
University of Michigan
American Rhinologic Society
Principal Investigator: Garrett R Griffin, MD University of Michigan
University of Michigan
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP