NCT01370577

Brief Summary

The Predictors for asthma control by stepwise treatment during 6 months in Korean elderly

Trial Health

87
On Track

Trial Health Score

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

Enrollment
297

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

5 active sites

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

First Submitted

Initial submission to the registry

June 1, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2011

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

January 14, 2013

Status Verified

January 1, 2013

Enrollment Period

1.3 years

First QC Date

June 1, 2011

Last Update Submit

January 11, 2013

Conditions

Asthma

Keywords

Predictors for asthma controlAsthma Exacerbation rateMean frequency of PFTsputum assessmentsrefill adherence(%)prescription persistence

Outcome Measures

Primary Outcomes (2)

  • Baseline characteristics related to asthma control in the elderly

    6 months

  • Asthma exacerbation rate of the elderly during guideline-based stepwise treatments

    6 months

Secondary Outcomes (3)

  • 1. Proportion of controlled, partially controlled, and controlled patients among the elderly patients with asthma in Korea

    6 months

  • 2. Baseline characteristics related to asthma specific QOL in the elderly patients with asthma

    6 months

  • Mean frequency of PFT, sputum assessments, refill adherence(%), prescription persistence in elderly asthma for the last 1 year before study enrollment

    6 months

Study Arms (1)

1

Total 300 subjects who was diagnosed with asthma

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects aged over 60 years, articulate in Korean, and diagnosed with asthma at least 1 year in duration

You may qualify if:

  • Patients aged 60 years or more, articulate in Korean
  • Patients diagnosed with asthma, at least 1 year in duration.

You may not qualify if:

  • Patients being followed-up for asthma treatment less than 1 year before baseline
  • Patients taking immune therapy
  • Patients previously enrolled/randomized in the present clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Research Site

Wŏnju, Gangwon-do, South Korea

Location

Research Site

Anyang-si, Gyeonggi-do, South Korea

Location

Research Site

Suwon, Gyeonggi-do, South Korea

Location

Research Site

Busan, Gyeonsangnam-do, South Korea

Location

Research Site

Changwon, Gyeonsangnam-do, South Korea

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Hye Won Koo

    AstraZeneca Korea

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2011

First Posted

June 10, 2011

Study Start

July 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

January 14, 2013

Record last verified: 2013-01

Locations

KR(5)