2nd_Computerized Asthma Specific Quality of Life(cAQOL) (2nd_cAQOL)

This study has been completed.
Sponsor:
Collaborators:
Yonsei University
Inha University Hospital
Dong-A University
Information provided by (Responsible Party):
Hae-Sim Park, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT01227083
First received: October 22, 2010
Last updated: November 10, 2013
Last verified: November 2013
  Purpose

Comparison of the responsiveness of two different asthma-specific QOL measures (AQLQ and cAQOL) in Korean patients with persistent asthma


Condition
Persistent Asthma Patient

Study Type: Observational
Official Title: Comparison of the Responsiveness of Two Different Asthma-specific QOL Measures (AQLQ and cAQOL) in Korean Patients With Persistent Asthma

Resource links provided by NLM:


Further study details as provided by Ajou University School of Medicine:

Primary Outcome Measures:
  • Two asthma quality of life measurement tool [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
    Two asthma quality of life measurement tool (cAQOL, AQLQ) and the correlation between ACT


Secondary Outcome Measures:
  • Correlation between cAQOL/AQLQ [ Time Frame: treatment screening, week1,week12,week24 ] [ Designated as safety issue: No ]
    -Correlation between cAQOL/AQLQ and other clinical parameters including FEV1, and asthma exacerbation.

  • Association of asthma control therapy and a questionnaire [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
    -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 [ Time Frame: Screening ] [ Designated as safety issue: No ]
    Sub-group of ADRB2 and NK2R genotypes


Biospecimen Retention:   Samples With DNA

Sub-group of ADRB2 and NK2R genotypes


Enrollment: 150
Study Start Date: October 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Asthma control test check AQLQ(Asthma Quality of Life Questionnaire)after being cAQOL(Computerized Asthma specific quality of life)
2
Asthma control test check cAQOL(Computerized Asthma specific quality of life)after being AQLQ(Asthma Quality of Life Questionnaire)

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

asthma control patient

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227083

Locations
Korea, Republic of
Ajou University Medical Center
Suwon, Korea, Republic of, 443-721
Sponsors and Collaborators
Ajou University School of Medicine
Yonsei University
Inha University Hospital
Dong-A University
Investigators
Principal Investigator: Hae-Sim Park, MD,PhD Ajou University School of Medicine
  More Information

No publications provided

Responsible Party: Hae-Sim Park, Professor, Department of Surgery, Ajou University School of Medicine, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01227083     History of Changes
Other Study ID Numbers: AJIRB-GEN-OBS-10-178
Study First Received: October 22, 2010
Last Updated: November 10, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Ajou University School of Medicine:
AQLQ and cAQOL

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 15, 2014