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Observational Study on Efficacy of Alvesco(Ciclesonide) in Asthma Children and Adolescent in Real Practice

This study has been completed.
Information provided by (Responsible Party):
Handok Pharmaceuticals Co., Ltd. Identifier:
First received: September 8, 2011
Last updated: August 21, 2012
Last verified: August 2012
This is a prospective, non-comparative, open, observational study.


Study Type: Observational
Study Design: Time Perspective: Prospective

Further study details as provided by Handok Pharmaceuticals Co., Ltd.:

Primary Outcome Measures:
  • Asthma control day [ Time Frame: 12weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Morning peak expiratory flow [ Time Frame: 12weeks ] [ Designated as safety issue: No ]
  • asthma exacerbation [ Time Frame: 12weeks ] [ Designated as safety issue: No ]
  • The number of Reliever use [ Time Frame: 12weeks ] [ Designated as safety issue: No ]
  • Asthma symptom score [ Time Frame: 12weeks ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events [ Time Frame: 12weeks ] [ Designated as safety issue: No ]

Enrollment: 274
Study Start Date: July 2010
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Inclusion Criteria:

  • Children who is prescribed with ciclesonide for asthma

Exclusion Criteria:

  • Subjects with contraindications to ciclesonide use
  • Subjects with clinically relevant concomitant disease that could compromise the patient's safety should not be included in this study.
  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 identifier: NCT01438255

Korea, Republic of
Handok Pharmaceuticals
Seoul, Korea, Republic of
Sponsors and Collaborators
Handok Pharmaceuticals Co., Ltd.
  More Information

Responsible Party: Handok Pharmaceuticals Co., Ltd. Identifier: NCT01438255     History of Changes
Other Study ID Numbers: ALVESCO-OS01 
Study First Received: September 8, 2011
Last Updated: August 21, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on December 02, 2016