Official Title

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

    Phase 3
  • Study Type

    Interventional
  • Study Participants

    23
That high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery.
Study Started
Sep 30
2010
Primary Completion
Jun 30
2012
Study Completion
Jun 30
2012
Results Posted
May 29
2018
Last Update
May 29
2018

Drug pulmicort

applied to nasal packing after surgery

  • Other names: budesonide

Single Arm; nostrils as experimental and comparator Other

each subject serves as their own control with one nostril being treated with pulmicort and one not

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

Summary

Single Arm; Nostrils as Experimental and Comparator

All Events

Event Type Organ System Event Term

Olfaction

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

Untreated Nostril (no Pulmicort)

19.8
units on a scale (Mean)
Full Range: 6.0 to 37.0

Treated Nostril (Pulmicort)

20.2
units on a scale (Mean)
Full Range: 8.0 to 36.0

Sinonasal Health

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.

Treated Nostril (Pulmicort)

4.5
units on a scale (Mean)
Full Range: 1.0 to 10.0

Placebo Treated Nostril (no Pulmicort)

4.7
units on a scale (Mean)
Full Range: 0.0 to 10.0

Olfaction

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

Treated Nostril (Pulmicort)

20.4
units on a scale (Mean)
Full Range: 9.0 to 37.0

Placebo/Untreated Nostril (no Pulmicort)

20.0
units on a scale (Mean)
Full Range: 7.0 to 38.0

Sinonasal Health

Assessed with Perioperative Sinus Endoscopy (POSE) score

Treated Nostril (Pulmicort)

5.6
units on a scale (Mean)
Full Range: 0.0 to 11.0

Untreated Nostril (no Pulmicort)

5.6
units on a scale (Mean)
Full Range: 2.0 to 11.0

Age, Categorical

Race (NIH/OMB)

Region of Enrollment

Sex: Female, Male

Overall Study

Single Arm; Nostrils as Experimental and Comparator