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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:
Information provided by (Responsible Party):
Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01438255
First received: September 8, 2011
Last updated: August 21, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition
Asthma

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Asthma
Drug Information available for: Ciclesonide
U.S. FDA Resources

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)

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438255

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

No publications provided

Responsible Party: Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov 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:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013