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

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ClinicalTrials.gov Identifier: NCT01197612
Recruitment Status : Completed
First Posted : September 9, 2010
Results First Posted : May 28, 2018
Last Update Posted : May 28, 2018
Sponsor:
Collaborator:
American Rhinologic Society
Information provided by (Responsible Party):
Garrett Griffin, University of Michigan

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Chronic Sinusitis
Polyposis
Intervention: Drug: pulmicort

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 23 participants who consented, data is only available for 20. Two never had surgery, and so were not "assigned" at all.

Reporting Groups
  Description
Single Arm; Nostrils as Experimental and Comparator

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

pulmicort: applied to nasal packing after surgery


Participant Flow:   Overall Study
    Single Arm; Nostrils as Experimental and Comparator
STARTED   18 
Week 3   16 
Returned for Week 24   6 
COMPLETED   6 
NOT COMPLETED   12 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Single Arm; Nostrils as Experimental and Comparator

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

pulmicort: applied to nasal packing after surgery


Baseline Measures
   Single Arm; Nostrils as Experimental and Comparator 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      18 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      7  38.9% 
Male      11  61.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
 
United States   18 


  Outcome Measures

1.  Primary:   Olfaction   [ Time Frame: 3 weeks post-operation ]

2.  Secondary:   Sinonasal Health   [ Time Frame: 3 weeks post operation ]

3.  Secondary:   Olfaction   [ Time Frame: 24 weeks post operation ]

4.  Secondary:   Sinonasal Health   [ Time Frame: 24 weeks post operation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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:  
Name/Title: Garrett Griffin, MD
Organization: University of Michigan
e-mail: ggriffin@mw-fp.com



Responsible Party: Garrett Griffin, University of Michigan
ClinicalTrials.gov Identifier: NCT01197612     History of Changes
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 28, 2018
Last Update Posted: May 28, 2018