2nd_Computerized Asthma Specific Quality of Life(cAQOL) (2nd_cAQOL)
Primary Purpose
Persistent Asthma Patient
Status
Completed
Phase
Locations
Korea, Republic of
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Persistent Asthma Patient focused on measuring AQLQ and cAQOL
Eligibility Criteria
Inclusion Criteria:
- Patient aged 20-70 years
- Patient diagnosed with asthma over six months ago
Asthma diagnosis
- Airway reversibility, FEV1 ≥ 12% and 200mL or
- Airway hyper-responsiveness, PC20 < 16 mg/mL or
- More than two weeks, more than 2 times a day in excess of 20% PEFR diurnal variability patient
- FEV1 55-100% of predicted value patient
- Inhaled corticosteroids alone or inhaled corticosteroids and beta agonists used patient
- Currently, at least if you have one or more asthma symptoms, asthma control test (ACT • Asthma Control Test) score of less than 19 characters
- Patients who sufficiently listen to the purpose and content of this trial and the properties of investigational products and voluntarily agree with the participation to sign a written consent approved by IRB of Ajou University Medical Center before the participation in this trial
Exclusion Criteria:
- Current smoking or smoking in the past 15packyears
- Patients who show a symptom of an acute disease within 14 days before the beginning of this trial (administration of trial medication)
- Recent changes in asthma treatment for 28days
- Chronic diseases that affect the quality of life
Sites / Locations
- Ajou University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Arm Label
1
2
Arm Description
Asthma control test check AQLQ(Asthma Quality of Life Questionnaire)after being cAQOL(Computerized Asthma specific quality of life)
Asthma control test check cAQOL(Computerized Asthma specific quality of life)after being AQLQ(Asthma Quality of Life Questionnaire)
Outcomes
Primary Outcome Measures
Two asthma quality of life measurement tool
Two asthma quality of life measurement tool (cAQOL, AQLQ) and the correlation between ACT
Secondary Outcome Measures
Correlation between cAQOL/AQLQ
-Correlation between cAQOL/AQLQ and other clinical parameters including FEV1, and asthma exacerbation.
Association of asthma control therapy and a questionnaire
-The proportion of subjects with achieving well controlled asthma within ACT & cAQOL-guided management strategy with ICS or ICS/LABA based on GINA 2006 guidelines during 24 weeks.
asthma patient genotypes
Sub-group of ADRB2 and NK2R genotypes
Full Information
NCT ID
NCT01227083
First Posted
October 22, 2010
Last Updated
November 10, 2013
Sponsor
Ajou University School of Medicine
Collaborators
Yonsei University, Inha University Hospital, Dong-A University
1. Study Identification
Unique Protocol Identification Number
NCT01227083
Brief Title
2nd_Computerized Asthma Specific Quality of Life(cAQOL)
Acronym
2nd_cAQOL
Official Title
Comparison of the Responsiveness of Two Different Asthma-specific QOL Measures (AQLQ and cAQOL) in Korean Patients With Persistent Asthma
Study Type
Observational
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
Collaborators
Yonsei University, Inha University Hospital, Dong-A University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparison of the responsiveness of two different asthma-specific QOL measures (AQLQ and cAQOL) in Korean patients with persistent asthma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Asthma Patient
Keywords
AQLQ and cAQOL
7. Study Design
Enrollment
150 (Actual)
Biospecimen Retention
Samples With DNA
Biospecimen Description
Sub-group of ADRB2 and NK2R genotypes
8. Arms, Groups, and Interventions
Arm Title
1
Arm Description
Asthma control test check AQLQ(Asthma Quality of Life Questionnaire)after being cAQOL(Computerized Asthma specific quality of life)
Arm Title
2
Arm Description
Asthma control test check cAQOL(Computerized Asthma specific quality of life)after being AQLQ(Asthma Quality of Life Questionnaire)
Primary Outcome Measure Information:
Title
Two asthma quality of life measurement tool
Description
Two asthma quality of life measurement tool (cAQOL, AQLQ) and the correlation between ACT
Time Frame
24 weeks treatment
Secondary Outcome Measure Information:
Title
Correlation between cAQOL/AQLQ
Description
-Correlation between cAQOL/AQLQ and other clinical parameters including FEV1, and asthma exacerbation.
Time Frame
treatment screening, week1,week12,week24
Title
Association of asthma control therapy and a questionnaire
Description
-The proportion of subjects with achieving well controlled asthma within ACT & cAQOL-guided management strategy with ICS or ICS/LABA based on GINA 2006 guidelines during 24 weeks.
Time Frame
24 weeks treatment
Title
asthma patient genotypes
Description
Sub-group of ADRB2 and NK2R genotypes
Time Frame
Screening
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient aged 20-70 years
Patient diagnosed with asthma over six months ago
Asthma diagnosis
Airway reversibility, FEV1 ≥ 12% and 200mL or
Airway hyper-responsiveness, PC20 < 16 mg/mL or
More than two weeks, more than 2 times a day in excess of 20% PEFR diurnal variability patient
FEV1 55-100% of predicted value patient
Inhaled corticosteroids alone or inhaled corticosteroids and beta agonists used patient
Currently, at least if you have one or more asthma symptoms, asthma control test (ACT • Asthma Control Test) score of less than 19 characters
Patients who sufficiently listen to the purpose and content of this trial and the properties of investigational products and voluntarily agree with the participation to sign a written consent approved by IRB of Ajou University Medical Center before the participation in this trial
Exclusion Criteria:
Current smoking or smoking in the past 15packyears
Patients who show a symptom of an acute disease within 14 days before the beginning of this trial (administration of trial medication)
Recent changes in asthma treatment for 28days
Chronic diseases that affect the quality of life
Study Population Description
asthma control patient
Sampling Method
Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hae-Sim Park, MD,PhD
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou University Medical Center
City
Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of
12. IPD Sharing Statement
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2nd_Computerized Asthma Specific Quality of Life(cAQOL)
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