Asthma Control, Quality of Life and Emotional Feelings in a Real Life Setting

NCT ID: NCT02640742

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1232 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-18

Study Completion Date

2016-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asthma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mitsuru Adachi, MD, PhD, Professor

Role: PRINCIPAL_INVESTIGATOR

International University of Health and Welfare

Gen Tamura, MD, PhD, President

Role: PRINCIPAL_INVESTIGATOR

Airway Institute in Sendai Co., Ltd

Masanori Nishikawa, DM, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Respiratory Medicine, Fujisawa City Hospital

Soichiro Hozawa, MD

Role: PRINCIPAL_INVESTIGATOR

Hiroshima Allergy and Respiratory Clinic

Locations

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Hiramatsu Clinic, Specializing in Internal Medicine, Respiratory Internal Medicine, Asthma, Sleep and Total Care of Rehabilitation in Respiratory in Komaki

Komaki, Aichi-ken, Japan

Site Status

Toyota Memorial Hospital

Toyota, Aichi-ken, Japan

Site Status

Ken Respiratory & Allergy Clinic

Hachinohe, Aomori, Japan

Site Status

Fukuokaken Saiseikai Futsukaichi Hospital

Chikushino-shi, Fukuoka, Japan

Site Status

Japan Community Health Care Organization Kurume General Hospital

Kurume, Fukuoka, Japan

Site Status

Kumashiro Hospital

Kurume, Fukuoka, Japan

Site Status

Ikedo Cardiovascular Medicine Clinic

Kurume, Fukuoka, Japan

Site Status

Omuta Tenryo Hospital

Omuta, Fukuoka, Japan

Site Status

Omuta Hospital

Omuta, Fukuoka, Japan

Site Status

Takagi Hospital

Ōkawa, Fukuoka, Japan

Site Status

Nagata Hospital

Yanagawa, Fukuoka, Japan

Site Status

Fujita General Hospital

Date-gun, Fukushima, Japan

Site Status

Tohno Chuo Clinic

Mizunami, Gifu, Japan

Site Status

Tsuchiya Clinic

Takasaki, Gunma, Japan

Site Status

Idaimae Minami Yojo Naika Clinic

Sapporo, Hokkaido, Japan

Site Status

Nakatani Hospital

Himeji, Hyōgo, Japan

Site Status

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Site Status

Kobe City Hospital Organization Kobe City Medical Center West Hospital

Kobe, Hyōgo, Japan

Site Status

Sudo Clinic

Morioka, Iwate, Japan

Site Status

Sakaide City Hospital

Sakaidechō, Kagawa-ken, Japan

Site Status

Takamatsu Hospital

Takamatsu, Kagawa-ken, Japan

Site Status

Kamei Internal Medicine & Respiratory Clinic

Takamatsu, Kagawa-ken, Japan

Site Status

Fujisawa City Hospital

Fujisawa, Kanagawa, Japan

Site Status

Yokohama City Minato Red Cross Hospital

Yokohama, Kanagawa, Japan

Site Status

Furuie Clinic

Yokohama, Kanagawa, Japan

Site Status

Saiseikai Yokohama Southern Hospital

Yokohama, Kanagawa, Japan

Site Status

Kanagawa Cardiovascular and Respiratory Center

Yokohama, Kanagawa, Japan

Site Status

National Hospital Organization Fukuoka-Higashi Medical Center

Fukuoka, Koga, Japan

Site Status

Sendai Medical Center

Sendai, Miyagi, Japan

Site Status

National Hospital Organization Minami-Okayama Medical Center

Tsukubo-gun, Okayama-ken, Japan

Site Status

Kawaguchi Respiratory Medicine Clinic

Higashiosaka, Osaka, Japan

Site Status

Ikeda City Hospital

Ikeda, Osaka, Japan

Site Status

Matsushita Memorial Hospital

Moriguchi, Osaka, Japan

Site Status

Takatsuki Red Cross Hospital

Takatsuki, Osaka, Japan

Site Status

Takatsuki General Hospital

Takatsuki, Osaka, Japan

Site Status

Hamamatsu Medical Center

Hamamatsu, Shizuoka, Japan

Site Status

Iwata City Hospital

Iwata, Shizuoka, Japan

Site Status

Nihonbashi Medical & Allergy Clinic

Cyuo-ku, Tokyo, Japan

Site Status

Futaba-cho Clinic

Itabashi-ku, Tokyo, Japan

Site Status

National Hospital Organization Tokyo National Hospital

Kiyose, Tokyo, Japan

Site Status

Yamazaki Chest Clinic

Koganei, Tokyo, Japan

Site Status

Jinyu Clinic Hospital

Nakano-ku, Tokyo, Japan

Site Status

Senzoku Kokyuuki & Allergy Clinic

Ōta-ku, Tokyo, Japan

Site Status

National Center for Global Health and Medicine

Shinjyuku-ku, Tokyo, Japan

Site Status

The Fraternity Memorial Hospital

Sumida-ku, Tokyo, Japan

Site Status

Yuizen Clinic

Tachikawa, Tokyo, Japan

Site Status

Hamanomachi Hospital

Fukuoka, , Japan

Site Status

Fukuoka Sanno Hospital

Fukuoka, , Japan

Site Status

Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers

Fukuoka, , Japan

Site Status

Ohara General Hospital

Fukushima, , Japan

Site Status

Sakurai Clinic

Hiroshima, , Japan

Site Status

Hiroshima Allergic & Respiratory Clinic

Hiroshima, , Japan

Site Status

Tsuya Internal Medicine & Respiratory Department Clinic

Hiroshima, , Japan

Site Status

Yodogawa Christian Hospital

Osaka, , Japan

Site Status

Saga-ken Medical Centre Koseikan

Saga, , Japan

Site Status

Saitama Red Cross Hospital

Saitama, , Japan

Site Status

Shizuoka General Hospital

Shizuoka, , Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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D2287R00101

Identifier Type: -

Identifier Source: org_study_id