Repeated High-dose Inhaled Corticosteroids for Asthma | NCT00695604

Studies
Repeated High-dose Inhaled Corticosteroids for Asthma

NCT00695604

Sponsor

University of Chicago

Status

Withdrawn

Last Update Posted

May 8, 2018Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Asthma

Interventions

Placebo
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

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was not able to be completed, no results analyzed.

Expanded Access Info

Start Date

May 2008Actual

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Jun 10, 2008

First Submission Date that Met QC Criteria

Jun 11, 2008

First Posted Date

Jun 12, 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

May 4, 2018

Last Update Posted Date

May 8, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 purpose of this study is to to compare the effects of high-dose Inhaled Corticosteroids (ICS) vs. placebo in adults with chronic stable asthma.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator	Placebo Comparator All patients assigned to this group will receive: Placebo via Metered Dose Inhaler (MDI). Albuterol via MDI.	Drug: Placebo
2	Active Comparator	Active Comparator All patients assigned to this group will receive: Fluticasone via MDI. Albuterol via MDI.	Drug: Fluticasone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo via MDI.	1
Fluticasone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Airflow inflammation.		Pre-study and post-study drug administration

Secondary Outcomes

Measure	Description	Time Frame
Airflow obstruction.		Pre-study and post-study drug administration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Physician diagnosis of asthma.
Age ≥18 years and ≤50 years
Evidence of airflow obstruction as measured by spirometry and flow-volume loop per American Thoracic Society guidelines.
Treatment for asthma with:
- daily inhaled corticosteroids and long-acting beta2-agonists, AND
- as-needed use of a short-acting beta2-agonist

Exclusion criteria:

History of >10 pack-year tobacco use
Other pulmonary or cardiac diagnosis that is actively being treated
History of adverse events or allergy to fluticasone
Systemic corticosteroid therapy within 7 days of study visit
Inability to obtain written informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jerry Krishnan, MD, PhD	University of Illinois at Chicago	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Chicago		Chicago	Illinois	60637	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