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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01438255
Recruitment Status : Completed
First Posted : September 22, 2011
Last Update Posted : August 23, 2012
Information provided by (Responsible Party):
Handok Pharmaceuticals Co., Ltd.

Brief Summary:
This is a prospective, non-comparative, open, observational study.

Condition or disease

Study Type : Observational
Actual Enrollment : 274 participants
Time Perspective: Prospective
Study Start Date : July 2010
Actual Primary Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources


Primary Outcome Measures :
  1. Asthma control day [ Time Frame: 12weeks ]

Secondary Outcome Measures :
  1. Morning peak expiratory flow [ Time Frame: 12weeks ]
  2. asthma exacerbation [ Time Frame: 12weeks ]
  3. The number of Reliever use [ Time Frame: 12weeks ]
  4. Asthma symptom score [ Time Frame: 12weeks ]
  5. Number of Participants with Adverse Events [ Time Frame: 12weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

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 identifier (NCT number): NCT01438255

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

Responsible Party: Handok Pharmaceuticals Co., Ltd. Identifier: NCT01438255     History of Changes
Other Study ID Numbers: ALVESCO-OS01
First Posted: September 22, 2011    Key Record Dates
Last Update Posted: August 23, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases