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Study of Inhaled Glucocorticosteroid Administration in Asthma Patients

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ClinicalTrials.gov Identifier: NCT00559689
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : March 16, 2009
Sponsor:
Information provided by:
Hamamatsu University

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

Condition or disease Intervention/treatment
Asthma Drug: Budesonide,hydrofluoroalkane-beclomethasone dipropionate Drug: Budesonide,hydrofluoroalkane-beclomethasone

Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Phase 4 Study of Once-Daily Inhaled Glucocorticosteroid Administration in Asthma Patients
Study Start Date : November 2005
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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




Primary Outcome Measures :
  1. once-daily administration of inhaled glucocorticosteroids can control airway inflammation [ Time Frame: two-year ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
University Hospital
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559689


Locations
Japan
Hamamatsu University School of Medicine
Hamamatsu, Japan, 431-3192
Sponsors and Collaborators
Hamamatsu University
Investigators
Study Chair: Kingo Chida, MD,PhD

ClinicalTrials.gov Identifier: NCT00559689     History of Changes
Other Study ID Numbers: Hamamatsu-17-43
H-17-43
First Posted: November 16, 2007    Key Record Dates
Last Update Posted: March 16, 2009
Last Verified: March 2009

Keywords provided by Hamamatsu University:
asthma patients
well-controlled

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Beclomethasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists