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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014