Non-invasive Measures of Distal Lung Disease in Asthmatics | NCT00250341

Studies
Non-invasive Measures of Distal Lung Disease in Asthmatics

NCT00250341

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Status

Completed

Last Update Posted

Dec 2, 2021Actual

Enrollment

34Estimated

Phase

Phase 4

Conditions

Asthma

Interventions

QVAR
Advair
Servent Diskus

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

Nov 2021

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

Sep 30, 2005Actual

Primary Completion Date

Sep 30, 2007Actual

Completion Date

Sep 30, 2007Actual

First Submitted Date

Nov 4, 2005

First Submission Date that Met QC Criteria

Nov 7, 2005

First Posted Date

Nov 8, 2005Estimated

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

Nov 19, 2021

Last Update Posted Date

Dec 2, 2021Actual

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 is a Phase 4, single center study conducted in mild-to moderate asthmatics.

Detailed Description

The study consists of 3 phases. There are 7 study visits.

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

34Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Advair	Active Comparator		Drug: Advair
QVAR	Experimental		Drug: QVAR Drug: Servent Diskus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
QVAR	Drug	480 mcg	QVAR	beclomethasone dipropionate HFA

Measure	Description	Time Frame
High resolution Cat Scans

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-65 years old
Currently using SABA prn or a low-to-moderate persistent asthma

Exclusion Criteria:

Tobacco use within 1 year or >= 5 pack years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michelle Zeidler, MD	University of California, Los Angeles	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCLA		Los Angeles	California	90095	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
D001507	Beclomethasone
D000068297	Fluticasone-Salmeterol Drug Combination

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided