NCT00559689

Brief Summary

Once-daily inhaled glucocorticosteroids treatment can sufficiently control airway inflammation in asthma patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2007

Completed
Last Updated

March 16, 2009

Status Verified

March 1, 2009

First QC Date

November 15, 2007

Last Update Submit

March 13, 2009

Conditions

Asthma

Keywords

asthma patientswell-controlled

Outcome Measures

Primary Outcomes (1)

  • once-daily administration of inhaled glucocorticosteroids can control airway inflammation

    two-year

Study Arms (2)

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

Budesonide,hydrofluoroalkane-beclomethasone dipropionateDRUG

receive twice-daily administration

2
Budesonide,hydrofluoroalkane-beclomethasoneDRUG

once-daily administration at bedtime

1

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

University Hospital

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamamatsu University School of Medicine

Hamamatsu, 431-3192, Japan

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Kingo Chida, MD,PhD

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2007

First Posted

November 16, 2007

Study Start

November 1, 2005

Study Completion

March 1, 2007

Last Updated

March 16, 2009

Record last verified: 2009-03

Locations

JP(1)