Study of Inhaled Glucocorticosteroid Administration in Asthma Patients

March 13, 2009 updated by: Hamamatsu University

Phase 4 Study of Once-Daily Inhaled Glucocorticosteroid Administration in Asthma Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hamamatsu, Japan, 431-3192
        • Hamamatsu University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

University Hospital

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
receive once-daily administration of inhaled glucocorticosteroids at bedtime
Drug: Budesonide,hydrofluoroalkane-beclomethasone
once-daily administration at bedtime
2
receive twice-daily administration of inhaled glucocorticosteroids
Drug: Budesonide,hydrofluoroalkane-beclomethasone dipropionate
receive twice-daily administration

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamamatsu University

Investigators

  • Study Chair: Kingo Chida, MD,PhD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

November 15, 2007

First Submitted That Met QC Criteria

November 15, 2007

First Posted (Estimate)

November 16, 2007

Study Record Updates

Last Update Posted (Estimate)

March 16, 2009

Last Update Submitted That Met QC Criteria

March 13, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hamamatsu-17-43
  • H-17-43

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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