The Predictors for Asthma Control by Stepwise Treatment During 6 Months in Korean Elderly (Prelude)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01370577
First received: June 1, 2011
Last updated: January 11, 2013
Last verified: January 2013
  Purpose

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


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Predictors for Asthma Control by Stepwise Treatment During 6 Months in Korean Elderly

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Baseline characteristics related to asthma control in the elderly [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Asthma exacerbation rate of the elderly during guideline-based stepwise treatments [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1. Proportion of controlled, partially controlled, and controlled patients among the elderly patients with asthma in Korea [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 2. Baseline characteristics related to asthma specific QOL in the elderly patients with asthma [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mean frequency of PFT, sputum assessments, refill adherence(%), prescription persistence in elderly asthma for the last 1 year before study enrollment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 297
Study Start Date: July 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Total 300 subjects who was diagnosed with asthma

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370577

Locations
Korea, Republic of
Research Site
Wonju, Gangwon-do, Korea, Republic of
Research Site
Anyang, Gyeonggi-do, Korea, Republic of
Research Site
Suwon, Gyeonggi-do, Korea, Republic of
Research Site
Busan, Gyeonsangnam-do, Korea, Republic of
Research Site
Changwon, Gyeonsangnam-do, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Hye Won Koo AstraZeneca Korea
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01370577     History of Changes
Other Study ID Numbers: NIS-RKR-XXX-2011/1
Study First Received: June 1, 2011
Last Updated: January 11, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by AstraZeneca:
Predictors for asthma control
Asthma Exacerbation rate
Mean frequency of PFT
sputum assessments
refill adherence(%)
prescription persistence

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 April 16, 2014