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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.
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
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").
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.
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| Measure | Description | Time Frame |
|---|---|---|
| The primary variable is status of asthma control in each patient | 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. | Day1 to Day7 |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma symptoms | To be evaluated based on Patient diary. | Baseline |
| Use of drugs for the treatment of asthma | To be evaluated from case report form. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult asthma patients receiving continued treatment by physician in Japan
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| Name | Affiliation | Role |
|---|---|---|
| Mitsuru Adachi, MD, PhD, Professor | International University of Health and Welfare | Principal Investigator |
| Gen Tamura, MD, PhD, President | Airway Institute in Sendai Co., Ltd | Principal Investigator |
| Masanori Nishikawa, DM, PhD | Department of Respiratory Medicine, Fujisawa City Hospital | Principal Investigator |
| Soichiro Hozawa, MD | Hiroshima Allergy and Respiratory Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hiramatsu Clinic, Specializing in Internal Medicine, Respiratory Internal Medicine, Asthma, Sleep and Total Care of Rehabilitation in Respiratory in Komaki | Komaki | Aichi-ken | 485-0041 | Japan |
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| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| Baseline |
| Asthma control during the past 1 week | To be evaluated by Asthma Control Questionare-5 (Japanese Version). | Baseline |
| Asthma control status during the past 1 month | To be evaluated based on Patients' Questionnaire, case report form. | Baseline |
| QOL | To be evaluated by Mini Asthma Quality of Life Questionnaire (Japanese Version) | Baseline |
| Use of drugs for asthma attack and emotional feelings | To be evaluated based on Patients' Questionnaire | Baseline |
| Toyota Memorial Hospital | Toyota | Aichi-ken | 471-8513 | Japan |
| Ken Respiratory & Allergy Clinic | Hachinohe | Aomori | 031-0011 | Japan |
| Fukuokaken Saiseikai Futsukaichi Hospital | Chikushino-shi | Fukuoka | 818-8516 | Japan |
| Japan Community Health Care Organization Kurume General Hospital | Kurume | Fukuoka | 830-0013 | Japan |
| Kumashiro Hospital | Kurume | Fukuoka | 830-1101 | Japan |
| Ikedo Cardiovascular Medicine Clinic | Kurume | Fukuoka | 839-1204 | Japan |
| Omuta Tenryo Hospital | Omuta | Fukuoka | 836-8566 | Japan |
| Omuta Hospital | Omuta | Fukuoka | 837-0911 | Japan |
| Takagi Hospital | Ōkawa | Fukuoka | 831-0016 | Japan |
| Nagata Hospital | Yanagawa | Fukuoka | 832-0059 | Japan |
| Fujita General Hospital | Date-gun | Fukushima | 969-1793 | Japan |
| Tohno Chuo Clinic | Mizunami | Gifu | 509-6134 | Japan |
| Tsuchiya Clinic | Takasaki | Gunma | 370-0006 | Japan |
| Idaimae Minami Yojo Naika Clinic | Sapporo | Hokkaido | 064-0804 | Japan |
| Nakatani Hospital | Himeji | Hyōgo | 672-8064 | Japan |
| Kobe City Medical Center General Hospital | Kobe | Hyōgo | 650-0047 | Japan |
| Kobe City Hospital Organization Kobe City Medical Center West Hospital | Kobe | Hyōgo | 653-0013 | Japan |
| Sudo Clinic | Morioka | Iwate | 020-0045 | Japan |
| Sakaide City Hospital | Sakaidechō | Kagawa-ken | 762-8550 | Japan |
| Takamatsu Hospital | Takamatsu | Kagawa-ken | 760-0018 | Japan |
| Kamei Internal Medicine & Respiratory Clinic | Takamatsu | Kagawa-ken | 761-8073 | Japan |
| Fujisawa City Hospital | Fujisawa | Kanagawa | 251-8550 | Japan |
| Yokohama City Minato Red Cross Hospital | Yokohama | Kanagawa | 231-8682 | Japan |
| Furuie Clinic | Yokohama | Kanagawa | 233-0013 | Japan |
| Saiseikai Yokohama Southern Hospital | Yokohama | Kanagawa | 234-0054 | Japan |
| Kanagawa Cardiovascular and Respiratory Center | Yokohama | Kanagawa | 236-0051 | Japan |
| National Hospital Organization Fukuoka-Higashi Medical Center | Fukuoka | Koga | 811-3195 | Japan |
| Sendai Medical Center | Sendai | Miyagi | 983-8520 | Japan |
| National Hospital Organization Minami-Okayama Medical Center | Tsukubo-gun | Okayama-ken | 701-0304 | Japan |
| Kawaguchi Respiratory Medicine Clinic | Higashiosaka | Osaka | 577-0843 | Japan |
| Ikeda City Hospital | Ikeda | Osaka | 563-8510 | Japan |
| Matsushita Memorial Hospital | Moriguchi | Osaka | 570-8540 | Japan |
| Takatsuki Red Cross Hospital | Takatsuki | Osaka | 569-1045 | Japan |
| Takatsuki General Hospital | Takatsuki | Osaka | 569-1192 | Japan |
| Hamamatsu Medical Center | Hamamatsu | Shizuoka | 432-8580 | Japan |
| Iwata City Hospital | Iwata | Shizuoka | 438-8550 | Japan |
| Nihonbashi Medical & Allergy Clinic | Cyuo-ku | Tokyo | 103-0022 | Japan |
| Futaba-cho Clinic | Itabashi-ku | Tokyo | 173-0011 | Japan |
| National Hospital Organization Tokyo National Hospital | Kiyose | Tokyo | 204-8585 | Japan |
| Yamazaki Chest Clinic | Koganei | Tokyo | 184-0003 | Japan |
| Jinyu Clinic Hospital | Nakano-ku | Tokyo | 164-0012 | Japan |
| Senzoku Kokyuuki & Allergy Clinic | Ōta-ku | Tokyo | 145-0063 | Japan |
| National Center for Global Health and Medicine | Shinjyuku-ku | Tokyo | 162-8655 | Japan |
| The Fraternity Memorial Hospital | Sumida-ku | Tokyo | 130-8587 | Japan |
| Yuizen Clinic | Tachikawa | Tokyo | 190-0013 | Japan |
| Hamanomachi Hospital | Fukuoka | 810-8539 | Japan |
| Fukuoka Sanno Hospital | Fukuoka | 814-0001 | Japan |
| Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers | Fukuoka | 815-8588 | Japan |
| Ohara General Hospital | Fukushima | 960-8611 | Japan |
| Sakurai Clinic | Hiroshima | 731-0103 | Japan |
| Hiroshima Allergic & Respiratory Clinic | Hiroshima | 732-0052 | Japan |
| Tsuya Internal Medicine & Respiratory Department Clinic | Hiroshima | 732-0062 | Japan |
| Yodogawa Christian Hospital | Osaka | 533-0024 | Japan |
| Saga-ken Medical Centre Koseikan | Saga | 840-8571 | Japan |
| Saitama Red Cross Hospital | Saitama | 338-8553 | Japan |
| Shizuoka General Hospital | Shizuoka | 420-8527 | Japan |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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