NCT01438255

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 22, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Last Updated

August 23, 2012

Status Verified

August 1, 2012

Enrollment Period

2 years

First QC Date

September 8, 2011

Last Update Submit

August 21, 2012

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Asthma control day

    12weeks

Secondary Outcomes (5)

  • Morning peak expiratory flow

    12weeks

  • asthma exacerbation

    12weeks

  • The number of Reliever use

    12weeks

  • Asthma symptom score

    12weeks

  • Number of Participants with Adverse Events

    12weeks

Study Arms (1)

Alvesco

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

outpatients

You may qualify if:

  • Children who is prescribed with ciclesonide for asthma

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Handok Pharmaceuticals

Seoul, Seoul, South Korea

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2011

First Posted

September 22, 2011

Study Start

July 1, 2010

Primary Completion

July 1, 2012

Last Updated

August 23, 2012

Record last verified: 2012-08

Locations

KR(1)