Clinical trial NCT02640742: Asthma Control, Quality of Life and Emotional Feelings in a Real Life Setting
Official title: Asthma Control, Quality of Life and Emotional Feelings in a Real Life Setting-A Cross-sectional Study of Adult Asthma Patients in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-12-29
Enrollment: 1232
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult asthma patients receiving continued treatment by physician in Japan

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary variable is status of asthma control in each patient
timeFrame: Day1 to Day7
Secondary outcomes:
measure: Asthma symptoms
timeFrame: Baseline
measure: Use of drugs for the treatment of asthma
timeFrame: Baseline
measure: Asthma control during the past 1 week
timeFrame: Baseline
measure: Asthma control status during the past 1 month
timeFrame: Baseline
measure: QOL
timeFrame: Baseline
measure: Use of drugs for asthma attack and emotional feelings
timeFrame: Baseline
Other outcomes:
Locations:
city: Komaki
country: Japan
facility: Hiramatsu Clinic, Specializing in Internal Medicine, Respiratory Internal Medicine, Asthma, Sleep and Total Care of Rehabilitation in Respiratory in Komaki
state: Aichi
city: Toyota
country: Japan
facility: Toyota Memorial Hospital
state: Aichi
city: Hachinohe
country: Japan
facility: Ken Respiratory & Allergy Clinic
state: Aomori
city: Chikushino
country: Japan
facility: Fukuokaken Saiseikai Futsukaichi Hospital
state: Fukuoka
city: Kurume
country: Japan
facility: Japan Community Health Care Organization Kurume General Hospital
state: Fukuoka
city: Kurume
country: Japan
facility: Kumashiro Hospital
state: Fukuoka
city: Kurume
country: Japan
facility: Ikedo Cardiovascular Medicine Clinic
state: Fukuoka
city: Okawa
country: Japan
facility: Takagi Hospital
state: Fukuoka
city: Omuta
country: Japan
facility: Omuta Tenryo Hospital
state: Fukuoka
city: Omuta
country: Japan
facility: Omuta Hospital
state: Fukuoka
city: Yanagawa
country: Japan
facility: Nagata Hospital
state: Fukuoka
city: Date-gun
country: Japan
facility: Fujita General Hospital
state: Fukushima
city: Mizunami
country: Japan
facility: Tohno Chuo Clinic
state: Gifu
city: Takasaki
country: Japan
facility: Tsuchiya Clinic
state: Gunma
city: Sapporo
country: Japan
facility: Idaimae Minami Yojo Naika Clinic
state: Hokkaido
city: Himeji
country: Japan
facility: Nakatani Hospital
state: Hyogo
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Kobe
country: Japan
facility: Kobe City Hospital Organization Kobe City Medical Center West Hospital
state: Hyogo
city: Morioka
country: Japan
facility: Sudo Clinic
state: Iwate
city: Sakaide
country: Japan
facility: Sakaide City Hospital
state: Kagawa
city: Takamatsu
country: Japan
facility: Takamatsu Hospital
state: Kagawa
city: Takamatsu
country: Japan
facility: Kamei Internal Medicine & Respiratory Clinic
state: Kagawa
city: Fujisawa
country: Japan
facility: Fujisawa City Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City Minato Red Cross Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Furuie Clinic
state: Kanagawa
city: Yokohama
country: Japan
facility: Saiseikai Yokohama Southern Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center
state: Kanagawa
city: Fukuoka
country: Japan
facility: National Hospital Organization Fukuoka-Higashi Medical Center
state: Koga
city: Sendai
country: Japan
facility: Sendai Medical Center
state: Miyagi
city: Tsukubo-gun
country: Japan
facility: National Hospital Organization Minami-Okayama Medical Center
state: Okayama
city: Higashi-osaka
country: Japan
facility: Kawaguchi Respiratory Medicine Clinic
state: Osaka
city: Ikeda
country: Japan
facility: Ikeda City Hospital
state: Osaka
city: Moriguchi
country: Japan
facility: Matsushita Memorial Hospital
state: Osaka
city: Takatsuki
country: Japan
facility: Takatsuki Red Cross Hospital
state: Osaka
city: Takatsuki
country: Japan
facility: Takatsuki General Hospital
state: Osaka
city: Hamamatsu
country: Japan
facility: Hamamatsu Medical Center
state: Shizuoka
city: Iwata
country: Japan
facility: Iwata City Hospital
state: Shizuoka
city: Cyuo-ku
country: Japan
facility: Nihonbashi Medical & Allergy Clinic
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Futaba-cho Clinic
state: Tokyo
city: Kiyose
country: Japan
facility: National Hospital Organization Tokyo National Hospital
state: Tokyo
city: Koganei
country: Japan
facility: Yamazaki Chest Clinic
state: Tokyo
city: Nakano-ku
country: Japan
facility: Jinyu Clinic Hospital
state: Tokyo
city: Ota-ku
country: Japan
facility: Senzoku Kokyuuki & Allergy Clinic
state: Tokyo
city: Shinjyuku-ku
country: Japan
facility: National Center for Global Health and Medicine
state: Tokyo
city: Sumida-ku
country: Japan
facility: The Fraternity Memorial Hospital
state: Tokyo
city: Tachikawa
country: Japan
facility: Yuizen Clinic
state: Tokyo
city: Fukuoka
country: Japan
facility: Hamanomachi Hospital
city: Fukuoka
country: Japan
facility: Fukuoka Sanno Hospital
city: Fukuoka
country: Japan
facility: Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers
city: Fukushima
country: Japan
facility: Ohara General Hospital
city: Hiroshima
country: Japan
facility: Sakurai Clinic
city: Hiroshima
country: Japan
facility: Hiroshima Allergic & Respiratory Clinic
city: Hiroshima
country: Japan
facility: Tsuya Internal Medicine & Respiratory Department Clinic
city: Osaka
country: Japan
facility: Yodogawa Christian Hospital
city: Saga
country: Japan
facility: Saga-ken Medical Centre Koseikan
city: Saitama
country: Japan
facility: Saitama Red Cross Hospital
city: Shizuoka
country: Japan
facility: Shizuoka General Hospital
Study officials:
affiliation: International University of Health and Welfare
name: Mitsuru Adachi, MD, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Airway Institute in Sendai Co., Ltd
name: Gen Tamura, MD, PhD, President
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Respiratory Medicine, Fujisawa City Hospital
name: Masanori Nishikawa, DM, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hiroshima Allergy and Respiratory Clinic
name: Soichiro Hozawa, MD
role: PRINCIPAL_INVESTIGATOR
References: