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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01438255
First Posted: September 22, 2011
Last Update Posted: August 23, 2012
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.
Information provided by (Responsible Party):
Handok Pharmaceuticals Co., Ltd.
  Purpose
This is a prospective, non-comparative, open, observational study.

Condition
Asthma

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 ]

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

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
outpatients
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01438255


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

Responsible Party: Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT01438255     History of Changes
Other Study ID Numbers: ALVESCO-OS01
First Submitted: September 8, 2011
First Posted: September 22, 2011
Last Update Posted: August 23, 2012
Last Verified: August 2012

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