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OpenTrials
Completed

NCT Number: NCT01197612

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.

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Key information

Conditions

Chronic Sinusitis Polyposis

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Michigan

Ann Arbor, Michigan, 48103, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pulmicort

Drug

applied to nasal packing after surgery

Other names: budesonide

Primary outcomes

  1. Olfaction

    Time frame: 3 weeks post-operation

    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

Secondary outcomes

  1. Sinonasal Health

    Time frame: 3 weeks post operation

    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.

  2. Olfaction

    Time frame: 24 weeks post operation

    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

  3. Sinonasal Health

    Time frame: 24 weeks post operation

    Assessed with Perioperative Sinus Endoscopy (POSE) score

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • American Rhinologic Society

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 9, 2010
Registry last updated
May 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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