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
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, see Learn About Clinical Studies.

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 September 22, 2014