Persistent Asthma Patient Clinical Trial
— 2nd_cAQOLOfficial title:
Comparison of the Responsiveness of Two Different Asthma-specific QOL Measures (AQLQ and cAQOL) in Korean Patients With Persistent Asthma
| Verified date | November 2013 |
| Source | Ajou University School of Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Food and Drug Administration |
| Study type | Observational |
Comparison of the responsiveness of two different asthma-specific QOL measures (AQLQ and cAQOL) in Korean patients with persistent asthma
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | July 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 70 Years |
| Eligibility |
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 |
N/A
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Ajou University Medical Center | Suwon |
| Lead Sponsor | Collaborator |
|---|---|
| Ajou University School of Medicine | Dong-A University, Inha University Hospital, Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Two asthma quality of life measurement tool | Two asthma quality of life measurement tool (cAQOL, AQLQ) and the correlation between ACT | 24 weeks treatment | No |
| Secondary | Correlation between cAQOL/AQLQ | -Correlation between cAQOL/AQLQ and other clinical parameters including FEV1, and asthma exacerbation. | treatment screening, week1,week12,week24 | No |
| Secondary | Association of asthma control therapy and a questionnaire | -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. | 24 weeks treatment | No |
| Secondary | asthma patient genotypes | Sub-group of ADRB2 and NK2R genotypes | Screening | No |