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Mucociliary Clearance Time in Chronic Rhinosinusitis (CRS) Patients After Sinus Surgery

Primary Purpose

Chronic Rhinosinusitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
1% Johnson's Baby Shampoo
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Rhinosinusitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • CRS
  • s/p sinus surgery

Exclusion Criteria:

  • nasal polyps

Sites / Locations

  • UT Department of Otolaryngology Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Johnson's Baby Shampoo

Arm Description

1% diluted solution

Outcomes

Primary Outcome Measures

Change in mucociliary clearance time (MCT)

Secondary Outcome Measures

Full Information

First Posted
July 28, 2009
Last Updated
March 18, 2010
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT00947986
Brief Title
Mucociliary Clearance Time in Chronic Rhinosinusitis (CRS) Patients After Sinus Surgery
Official Title
Effect of Baby Shampoo Nasal Irrigation on Mucociliary Clearance Time in Patients After Sinus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators are looking at the effects of baby shampoo nasal irrigation on the movement of mucous in the nose in patients who have undergone sinus surgery for chronic sinus problems.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Johnson's Baby Shampoo
Arm Type
Experimental
Arm Description
1% diluted solution
Intervention Type
Other
Intervention Name(s)
1% Johnson's Baby Shampoo
Intervention Description
nasal irrigation 2x a day for 4 weeks
Primary Outcome Measure Information:
Title
Change in mucociliary clearance time (MCT)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: CRS s/p sinus surgery Exclusion Criteria: nasal polyps
Facility Information:
Facility Name
UT Department of Otolaryngology Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Mucociliary Clearance Time in Chronic Rhinosinusitis (CRS) Patients After Sinus Surgery

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