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

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ClinicalTrials.gov Identifier: NCT01370577
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : January 14, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The Predictors for asthma control by stepwise treatment during 6 months in Korean elderly

Condition or disease
Asthma

Study Design

Study Type : Observational
Actual Enrollment : 297 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Predictors for Asthma Control by Stepwise Treatment During 6 Months in Korean Elderly
Study Start Date : July 2011
Primary Completion Date : November 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1
Total 300 subjects who was diagnosed with asthma


Outcome Measures

Primary Outcome Measures :
  1. Baseline characteristics related to asthma control in the elderly [ Time Frame: 6 months ]
  2. Asthma exacerbation rate of the elderly during guideline-based stepwise treatments [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 1. Proportion of controlled, partially controlled, and controlled patients among the elderly patients with asthma in Korea [ Time Frame: 6 months ]
  2. 2. Baseline characteristics related to asthma specific QOL in the elderly patients with asthma [ Time Frame: 6 months ]
  3. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01370577     History of Changes
Other Study ID Numbers: NIS-RKR-XXX-2011/1
First Posted: June 10, 2011    Key Record Dates
Last Update Posted: January 14, 2013
Last Verified: January 2013

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