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NCT01438255 Clinical Trial

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

Asthma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01438255
Other study ID # ALVESCO-OS01
Secondary ID
Status Completed
Phase N/A
First received September 8, 2011
Last updated August 21, 2012
Start date July 2010

Study information
Verified date August 2012
Source Handok Pharmaceuticals Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 274
Est. completion date
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 18 Years
Eligibility 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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Handok Pharmaceuticals Seoul

Sponsors (1)
Lead Sponsor Collaborator
Handok Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Asthma control day 12weeks No
Secondary Morning peak expiratory flow 12weeks No
Secondary asthma exacerbation 12weeks No
Secondary The number of Reliever use 12weeks No
Secondary Asthma symptom score 12weeks No
Secondary Number of Participants with Adverse Events 12weeks No
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