Mucociliary Clearance Time in Chronic Rhinosinusitis (CRS... | NCT00947986

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

NCT00947986

Sponsor

The University of Texas Health Science Center, Houston

Status

Completed

Last Update Posted

Mar 22, 2010Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Chronic Rhinosinusitis

Interventions

1% Johnson's Baby Shampoo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

Jul 28, 2009

First Submission Date that Met QC Criteria

Jul 28, 2009

First Posted Date

Jul 29, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2010

Last Update Posted Date

Mar 22, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Johnson's Baby Shampoo	Experimental	1% diluted solution	Other: 1% Johnson's Baby Shampoo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
1% Johnson's Baby Shampoo	Other	nasal irrigation 2x a day for 4 weeks	Johnson's Baby Shampoo

Measure	Description	Time Frame
Change in mucociliary clearance time (MCT)		4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CRS
s/p sinus surgery

Exclusion Criteria:

nasal polyps

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UT Department of Otolaryngology Clinic		Houston	Texas	77030	United States