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Study of Inhaled Glucocorticosteroid Administration in Asthma Patients

This study has been completed.
Sponsor:
Information provided by:
Hamamatsu University
ClinicalTrials.gov Identifier:
NCT00559689
First received: November 15, 2007
Last updated: March 13, 2009
Last verified: March 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Asthma
 Drug: Budesonide,hydrofluoroalkane-beclomethasone dipropionate
Drug: Budesonide,hydrofluoroalkane-beclomethasone
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Phase 4 Study of Once-Daily Inhaled Glucocorticosteroid Administration in Asthma Patients

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Hamamatsu University:

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

Enrollment: 24
Study Start Date: November 2005
Study Completion Date: March 2007
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559689

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

No publications provided

ClinicalTrials.gov Identifier: NCT00559689     History of Changes
Other Study ID Numbers: Hamamatsu-17-43, H-17-43
Study First Received: November 15, 2007
Last Updated: March 13, 2009
Health Authority: Japan: Institutional Review Board

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
Beclomethasone
Budesonide
Anti-Inflammatory Agents
 Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013