2nd_Computerized Asthma Specific Quality of Life(cAQOL)

Completed

• Conditions: Persistent Asthma Patient

• Registration Number: NCT01227083
• Lead Sponsor: Ajou University School of Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-22
• Study First Submitted QC: 2010-10-22
• Study First Posted: 2010-10-25
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-10
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Two asthma quality of life measurement tool	24 weeks treatment	Two asthma quality of life measurement tool (cAQOL, AQLQ) and the correlation between ACT

Secondary Outcome Measures

Name	Time	Method
Association of asthma control therapy and a questionnaire	24 weeks treatment	-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	Screening	Sub-group of ADRB2 and NK2R genotypes
Correlation between cAQOL/AQLQ	treatment screening, week1,week12,week24	-Correlation between cAQOL/AQLQ and other clinical parameters including FEV1, and asthma exacerbation.

Trial Locations

Locations (1)

Ajou University Medical Center; 🇰🇷 Suwon, Korea, Republic of