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:
Ajou University School of Medicine
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
| Estimated Enrollment: | 150 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | April 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
Contacts
| 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 |
Locations
| Korea, Republic of | |
| Ajou University Medical Center | Recruiting |
| Suwon, Korea, Republic of, 443-721 | |
| Contact: YunKyoung Kim, CRA 82-31-219-4467 forsake326@ajou.ac.kr | |
| Contact: Young-Min Ye, MD 82-31-219-4262 ye9007@ajou.ac.kr | |
| Principal Investigator: Hae-Sim Park, MD,PhD | |
| Sub-Investigator: Young-Min Ye, MD | |
| Sub-Investigator: Seung-Hyun Kim, PhD | |
| Sub-Investigator: Hyun-Jeong Jin, MD | |
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: | February 20, 2012 |
| 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 May 23, 2013