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

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.
 
ClinicalTrials.gov Identifier: NCT01197612
Recruitment Status : Completed
First Posted : September 9, 2010
Results First Posted : May 29, 2018
Last Update Posted : May 29, 2018
Sponsor:
Collaborator:
American Rhinologic Society
Information provided by (Responsible Party):
Garrett Griffin, University of Michigan

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Chronic Sinusitis
Polyposis
Intervention Drug: pulmicort
Enrollment 23
Recruitment Details  
Pre-assignment Details Of 23 participants who consented, data is only available for 20. Two never had surgery, and so were not "assigned" at all.
Arm/Group Title Single Arm; Nostrils as Experimental and Comparator
Hide Arm/Group Description

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

pulmicort: applied to nasal packing after surgery

Period Title: Overall Study
Started 18
Week 3 16
Returned for Week 24 6
Completed 6
Not Completed 12
Arm/Group Title Single Arm; Nostrils as Experimental and Comparator
Hide Arm/Group Description

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

pulmicort: applied to nasal packing after surgery

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
18
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
7
  38.9%
Male
11
  61.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   5.6%
White
17
  94.4%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title Olfaction
Hide Description 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
Time Frame 3 weeks post-operation
Hide Outcome Measure Data
Hide Analysis Population Description
Of sixteen participants at the three week mark, one participant's data was unable to be unblinded accurately, and one participant had no UPSIT scores taken, leaving an analysis population of 14,
Arm/Group Title Treated Nostril (Pulmicort) Untreated Nostril (no Pulmicort)
Hide Arm/Group Description:

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

pulmicort: applied to nasal packing after surgery

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

pulmicort: applied to nasal packing after surgery

Overall Number of Participants Analyzed 14 14
Mean (Full Range)
Unit of Measure: units on a scale
20.2
(8 to 36)
19.8
(6 to 37)
2.Secondary Outcome
Title Sinonasal Health
Hide Description 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.
Time Frame 3 weeks post operation
Hide Outcome Measure Data
Hide Analysis Population Description
unblinding could not be done on one person accurately, so only 15 rather than 16 people's data could be analyzed
Arm/Group Title Treated Nostril (Pulmicort) Placebo Treated Nostril (no Pulmicort)
Hide Arm/Group Description:

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

pulmicort: applied to nasal packing after surgery

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

pulmicort: applied to nasal packing after surgery

Overall Number of Participants Analyzed 15 15
Mean (Full Range)
Unit of Measure: units on a scale
4.5
(1 to 10)
4.7
(0 to 10)
3.Secondary Outcome
Title Olfaction
Hide Description 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
Time Frame 24 weeks post operation
Hide Outcome Measure Data
Hide Analysis Population Description
Of six participants remaining at 24 weeks, one participant's data could not be accurately unblinded leaving analysis of 5
Arm/Group Title Treated Nostril (Pulmicort) Placebo/Untreated Nostril (no Pulmicort)
Hide Arm/Group Description:

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

pulmicort: applied to nasal packing after surgery

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

pulmicort: applied to nasal packing after surgery

Overall Number of Participants Analyzed 5 5
Mean (Full Range)
Unit of Measure: units on a scale
20.4
(9 to 37)
20
(7 to 38)
4.Secondary Outcome
Title Sinonasal Health
Hide Description Assessed with Perioperative Sinus Endoscopy (POSE) score
Time Frame 24 weeks post operation
Hide Outcome Measure Data
Hide Analysis Population Description
Of six participants at 24 weeks, one's data was unable to be unblinded accurately, leaving an analysis population of 5 participants
Arm/Group Title Treated Nostril (Pulmicort) Untreated Nostril (no Pulmicort)
Hide Arm/Group Description:

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

pulmicort: applied to nasal packing after surgery

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

pulmicort: applied to nasal packing after surgery

Overall Number of Participants Analyzed 5 5
Mean (Full Range)
Unit of Measure: units on a scale
5.6
(0 to 11)
5.6
(2 to 11)
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm; Nostrils as Experimental and Comparator
Hide Arm/Group Description

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

pulmicort: applied to nasal packing after surgery

All-Cause Mortality
Single Arm; Nostrils as Experimental and Comparator
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Single Arm; Nostrils as Experimental and Comparator
Affected / at Risk (%)
Total   0/18 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Arm; Nostrils as Experimental and Comparator
Affected / at Risk (%)
Total   0/18 (0.00%) 
This was a pilot study with less enrollment than desired and poor rate of completion with only 5 participants completing the full 24 week trial. This study could be done on a larger/similar scale with some additional useful data obtained.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Garrett Griffin, MD
Organization: University of Michigan
EMail: ggriffin@mw-fp.com
Layout table for additonal information
Responsible Party: Garrett Griffin, University of Michigan
ClinicalTrials.gov Identifier: NCT01197612    
Other Study ID Numbers: HUM00029273
First Submitted: August 30, 2010
First Posted: September 9, 2010
Results First Submitted: April 24, 2018
Results First Posted: May 29, 2018
Last Update Posted: May 29, 2018