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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
August 30, 2010
September 9, 2010
September 12, 2017
September 2010
June 2012   (Final data collection date for primary outcome measure)
olfaction [ Time Frame: 3 weeks post-op ]
will be measured with the University of Pennsylvania Smell Identification Test (UPSIT)
Same as current
Complete list of historical versions of study NCT01197612 on ClinicalTrials.gov Archive Site
  • 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
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
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Chronic Sinusitis
  • Polyposis
Drug: pulmicort
applied to nasal packing after surgery
Other Name: budesonide
Single Arm; nostrils as experimental and comparator
each subject serves as their own control with one nostril being treated with pulmicort and one not
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.
 
Completed
23
Not Provided
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 99 Years   (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
University of Michigan
American Rhinologic Society
Principal Investigator: Garrett R Griffin, MD University of Michigan
University of Michigan
September 2017

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