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

This study is currently recruiting participants.

Verified February 2012 by Ajou University School of Medicine

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: February 20, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 22, 2010

Last Updated Date

February 20, 2012

Start Date ^ICMJE

October 2010

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01227083 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

2nd_Computerized Asthma Specific Quality of Life(cAQOL)

Official Title ^ICMJE

Comparison of the Responsiveness of Two Different Asthma-specific QOL Measures (AQLQ and cAQOL) in Korean Patients With Persistent Asthma

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 Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Sub-group of ADRB2 and NK2R genotypes

Sampling Method

Probability Sample

Study Population

asthma control patient

Condition ^ICMJE

Persistent Asthma Patient

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

April 2012

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Hae-Sim Park, MD, PhD	82-31-219-5196	hspark@ajou.ac.kr
Contact: Young-Min Ye, MD	82-31-219-4262	ye9007@ajou.ac.kr

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01227083

Other Study ID Numbers ^ICMJE

AJIRB-GEN-OBS-10-178

Has Data Monitoring Committee

Responsible Party

Hae-Sim Park, Ajou University School of Medicine

Study Sponsor ^ICMJE

Ajou University School of Medicine

Collaborators ^ICMJE

Yonsei University
Inha University Hospital
Dong-A University

Investigators ^ICMJE

Principal Investigator:

Hae-Sim Park, MD,PhD

Ajou University School of Medicine

Information Provided By

Ajou University School of Medicine

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top