Dose Response Effects of Inhaled Fluticasone on Airway Ef... | NCT00606242

Studies
Dose Response Effects of Inhaled Fluticasone on Airway Effects of Hypertonic-saline in Asthma

NCT00606242

Sponsor

University of California, San Francisco

Status

Completed

Last Update Posted

Mar 10, 2014Estimated

Enrollment

44Actual

Phase

Phase 4

Conditions

Asthma

Interventions

Fluticasone

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

ID	Type	Description	Link
5P50HL056385	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2014

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

Jan 2000

Primary Completion Date

Dec 2002Actual

Completion Date

Dec 2007Actual

First Submitted Date

Jan 21, 2008

First Submission Date that Met QC Criteria

Jan 21, 2008

First Posted Date

Feb 1, 2008Estimated

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 6, 2014

Last Update Posted Date

Mar 10, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of California, San FranciscoOTHER

Collaborators

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH
GlaxoSmithKline	INDUSTRY

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

This study investigates the effect of a inhaled corticosteroid (fluticasone or "Flovent") on airway narrowing induced by hypertonic saline (salty water). The study hypothesis is that fluticasone will be more effective in preventing saline-induced airway narrowing than methacholine-induced narrowing.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low dose steroid	Active Comparator	Fluticasone, 100 mcg per day	Drug: Fluticasone
High dose steroid	Active Comparator	Fluticasone, 1000 mcg per day	Drug: Fluticasone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fluticasone	Drug	Inhaled Fluticasone, either 100 or 1000 mcg per day	High dose steroid Low dose steroid

Measure	Description	Time Frame
FEV1		Measured every 2 weeks

Measure	Description	Time Frame
PC20 methacholine		Measured every 2 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of asthma

Exclusion Criteria:

Habitual cigarette smoking

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 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
University of California, San Francisco		San Francisco	California	94143	United States

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068298	Fluticasone

Ancestor Terms

ID	Term
D000730	Androstadienes
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided