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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

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
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: 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
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014