Asthma Control, Quality of Life and Emotional Feelings in a Real Life Setting
- Conditions
- Asthma
- Registration Number
- NCT02640742
- Lead Sponsor
- AstraZeneca
- Brief Summary
This study aims to evaluate the asthma control status, asthma symptoms (severity, frequency, and limitations on activities, etc.), QOL, and use of drugs for asthma attack in adult asthma patients.
- Detailed Description
Rationale for this Non-Interventional Study According to the Japanese Asthma Prevention and Management Guideline 2015 (Japan guideline (JGL) 2015), the goal in the management and treatment of asthma is "to be able to lead a life like a healthy individual." In order to achieve this therapeutic goal, the achievement of "well-controlled" state based on the asthma control status is considered to be a clinical goal. However, there are few studies in which the asthma control status is accurately surveyed in a real life setting in adult asthma patients receiving continued treatment from physician in Japan and the actual situation is unknown. By understanding the status of asthma control in asthma patients in a real life setting, the clinical issues could be clarified. Therefore, such information would contribute to appropriate treatment of asthma.
Thus, we planned this study to evaluate the asthma control status, asthma symptoms (severity, frequency, and limitations on activities, etc.), Quality of line (QOL), and use of drugs for asthma attack in the study population in a real life setting by recruiting patients through medical institutions providing continued care for asthma patients.
Objectives of this Non-Interventional Study
1. Primary objective
To assess the proportion of adult asthma patients receiving continued treatment from physician in Japan in each asthma control status defined by JGL 2015 ("poorly-controlled," "insufficiently-controlled," and "well-controlled").
2. Secondary objectives
To evaluate asthma symptoms (intensity, frequency, and limitations on activities, etc.), QOL, use of drugs for asthma attack, and emotional feelings in the study population; and to investigate the effects of demographic characteristics and pathologic properties of each patient on the status of asthma control, asthma symptoms, QOL, use of drugs for asthma attack, and emotional feelings.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1232
- Provided written consent before starting any procedure specified in the study protocol
- Aged 20 years or older at the time of providing the consent
- Receiving treatment for asthma as an outpatient at the time of providing the consent
- Physician definitive diagnosis of asthma at least 1 year before providing the consent
- Started to receive treatment with at least 1 of the following asthma drugs at least 1 year before providing the consent
- Enrolled in this study in the past
- Assessed by the Investigator to require additional treatment due to worsening of asthma symptoms at the time of providing the consentEnrolled in this study in the past
- Scheduled to be hospitalized within 2 weeks after providing the consent due to asthma or any other disease
- Participating in another interventional study such as a clinical study at the time of providing the consent
- Considered by the Investigator as not appropriate for enrollment in this study due to inability to adhere to the procedures, limitations, and requirements of this study including answering and returning the questionnaires, etc.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary variable is status of asthma control in each patient Day1 to Day7 Status of asthma control will be evaluated based on the patient diary and information in the clinical report form (CRF). Of the 6 items of Japanese guideline(JGL) 2015, the following 4 items will be used as indicators for evaluation of asthma control status: asthma symptoms (daytime and nighttime), use of a drug for asthma attack, limitation on activities including exercise, exacerbation (unscheduled visit, emergency room visit, and hospitalization).
Status of asthma control in each patient ("well controlled," "insufficiently controlled," and "poorly-controlled" ) will be evaluated according to the evaluation criteria in JGL 2015.
- Secondary Outcome Measures
Name Time Method Use of drugs for asthma attack and emotional feelings Baseline To be evaluated based on Patients' Questionnaire
Use of drugs for the treatment of asthma Baseline To be evaluated from case report form.
Asthma control status during the past 1 month Baseline To be evaluated based on Patients' Questionnaire, case report form.
Asthma control during the past 1 week Baseline To be evaluated by Asthma Control Questionare-5 (Japanese Version).
QOL Baseline To be evaluated by Mini Asthma Quality of Life Questionnaire (Japanese Version)
Asthma symptoms Baseline To be evaluated based on Patient diary.
Trial Locations
- Locations (57)
Fukuokaken Saiseikai Futsukaichi Hospital
🇯🇵Chikushino, Fukuoka, Japan
Japan Community Health Care Organization Kurume General Hospital
🇯🇵Kurume, Fukuoka, Japan
Omuta Tenryo Hospital
🇯🇵Omuta, Fukuoka, Japan
Tohno Chuo Clinic
🇯🇵Mizunami, Gifu, Japan
Tsuchiya Clinic
🇯🇵Takasaki, Gunma, Japan
Nakatani Hospital
🇯🇵Himeji, Hyogo, Japan
Kobe City Hospital Organization Kobe City Medical Center West Hospital
🇯🇵Kobe, Hyogo, Japan
Sudo Clinic
🇯🇵Morioka, Iwate, Japan
Sakaide City Hospital
🇯🇵Sakaide, Kagawa, Japan
Takamatsu Hospital
🇯🇵Takamatsu, Kagawa, Japan
Kamei Internal Medicine & Respiratory Clinic
🇯🇵Takamatsu, Kagawa, Japan
Fujisawa City Hospital
🇯🇵Fujisawa, Kanagawa, Japan
Yokohama City Minato Red Cross Hospital
🇯🇵Yokohama, Kanagawa, Japan
Furuie Clinic
🇯🇵Yokohama, Kanagawa, Japan
National Hospital Organization Minami-Okayama Medical Center
🇯🇵Tsukubo-gun, Okayama, Japan
Kawaguchi Respiratory Medicine Clinic
🇯🇵Higashi-osaka, Osaka, Japan
Ikeda City Hospital
🇯🇵Ikeda, Osaka, Japan
Matsushita Memorial Hospital
🇯🇵Moriguchi, Osaka, Japan
Takatsuki Red Cross Hospital
🇯🇵Takatsuki, Osaka, Japan
Iwata City Hospital
🇯🇵Iwata, Shizuoka, Japan
Hamamatsu Medical Center
🇯🇵Hamamatsu, Shizuoka, Japan
Nihonbashi Medical & Allergy Clinic
🇯🇵Cyuo-ku, Tokyo, Japan
Futaba-cho Clinic
🇯🇵Itabashi-ku, Tokyo, Japan
Jinyu Clinic Hospital
🇯🇵Nakano-ku, Tokyo, Japan
Yuizen Clinic
🇯🇵Tachikawa, Tokyo, Japan
Hamanomachi Hospital
🇯🇵Fukuoka, Japan
Fukuoka Sanno Hospital
🇯🇵Fukuoka, Japan
Saitama Red Cross Hospital
🇯🇵Saitama, Japan
Shizuoka General Hospital
🇯🇵Shizuoka, Japan
Toyota Memorial Hospital
🇯🇵Toyota, Aichi, Japan
Takagi Hospital
🇯🇵Okawa, Fukuoka, Japan
Sendai Medical Center
🇯🇵Sendai, Miyagi, Japan
Yamazaki Chest Clinic
🇯🇵Koganei, Tokyo, Japan
Ohara General Hospital
🇯🇵Fukushima, Japan
Saga-ken Medical Centre Koseikan
🇯🇵Saga, Japan
Idaimae Minami Yojo Naika Clinic
🇯🇵Sapporo, Hokkaido, Japan
Hiramatsu Clinic, Specializing in Internal Medicine, Respiratory Internal Medicine, Asthma, Sleep and Total Care of Rehabilitation in Respiratory in Komaki
🇯🇵Komaki, Aichi, Japan
Ken Respiratory & Allergy Clinic
🇯🇵Hachinohe, Aomori, Japan
Kumashiro Hospital
🇯🇵Kurume, Fukuoka, Japan
Ikedo Cardiovascular Medicine Clinic
🇯🇵Kurume, Fukuoka, Japan
Omuta Hospital
🇯🇵Omuta, Fukuoka, Japan
Nagata Hospital
🇯🇵Yanagawa, Fukuoka, Japan
Saiseikai Yokohama Southern Hospital
🇯🇵Yokohama, Kanagawa, Japan
Fujita General Hospital
🇯🇵Date-gun, Fukushima, Japan
National Hospital Organization Fukuoka-Higashi Medical Center
🇯🇵Fukuoka, Koga, Japan
Senzoku Kokyuuki & Allergy Clinic
🇯🇵Ota-ku, Tokyo, Japan
Sakurai Clinic
🇯🇵Hiroshima, Japan
Hiroshima Allergic & Respiratory Clinic
🇯🇵Hiroshima, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe, Hyogo, Japan
National Center for Global Health and Medicine
🇯🇵Shinjyuku-ku, Tokyo, Japan
Kanagawa Cardiovascular and Respiratory Center
🇯🇵Yokohama, Kanagawa, Japan
National Hospital Organization Tokyo National Hospital
🇯🇵Kiyose, Tokyo, Japan
Takatsuki General Hospital
🇯🇵Takatsuki, Osaka, Japan
The Fraternity Memorial Hospital
🇯🇵Sumida-ku, Tokyo, Japan
Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers
🇯🇵Fukuoka, Japan
Tsuya Internal Medicine & Respiratory Department Clinic
🇯🇵Hiroshima, Japan
Yodogawa Christian Hospital
🇯🇵Osaka, Japan