Study of Inhaled Glucocorticosteroid Administration in As... | NCT00559689

Studies
Study of Inhaled Glucocorticosteroid Administration in Asthma Patients

NCT00559689

Sponsor

Hamamatsu University

Status

Completed

Last Update Posted

Mar 16, 2009Estimated

Enrollment

24Actual

Phase

Not provided

Conditions

Asthma

Interventions

Budesonide,hydrofluoroalkane-beclomethasone dipropionate
Budesonide,hydrofluoroalkane-beclomethasone

Countries

Japan

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
H-17-43

Status Module

Record Verification Date

Mar 2009

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

Nov 2005

Primary Completion Date

Not provided

Completion Date

Mar 2007Actual

First Submitted Date

Nov 15, 2007

First Submission Date that Met QC Criteria

Nov 15, 2007

First Posted Date

Nov 16, 2007Estimated

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 13, 2009

Last Update Posted Date

Mar 16, 2009Estimated

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

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		receive once-daily administration of inhaled glucocorticosteroids at bedtime	Drug: Budesonide,hydrofluoroalkane-beclomethasone
2		receive twice-daily administration of inhaled glucocorticosteroids	Drug: Budesonide,hydrofluoroalkane-beclomethasone dipropionate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Budesonide,hydrofluoroalkane-beclomethasone dipropionate	Drug	receive twice-daily administration	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
once-daily administration of inhaled glucocorticosteroids can control airway inflammation		two-year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Receive ICS for one year or more, with no change in dose within the previous 8 weeks

Exclusion Criteria:

Two or more courses of oral corticosteroid in the previous 12 months
Admission to hospital due to asthma in the previous 6 months
Admission to the intensive care unit due to asthma at any time in the past
Current cigarette smoker.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

University Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kingo Chida, MD,PhD		Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hamamatsu University School of Medicine		Hamamatsu		431-3192	Japan

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
D019819	Budesonide

Ancestor Terms

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided