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

Asthma Clinical Trial

— ACQUIRE-2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02640742
• Other study ID #: D2287R00101
• Status: Completed
• Phase: N/A
• First received: December 16, 2015
• Last updated: October 24, 2017
• Start date: December 18, 2015
• Est. completion date: June 1, 2016

Study information

• Verified date: October 2017
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1232
• Est. completion date: June 1, 2016
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
Japan	Fukuokaken Saiseikai Futsukaichi Hospital	Chikushino	Fukuoka
Japan	Nihonbashi Medical & Allergy Clinic	Cyuo-ku	Tokyo
Japan	Fujita General Hospital	Date-gun	Fukushima
Japan	Fujisawa City Hospital	Fujisawa	Kanagawa
Japan	Fukuoka Sanno Hospital	Fukuoka
Japan	Hamanomachi Hospital	Fukuoka
Japan	Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers	Fukuoka
Japan	National Hospital Organization Fukuoka-Higashi Medical Center	Fukuoka	Koga
Japan	Ohara General Hospital	Fukushima
Japan	Ken Respiratory & Allergy Clinic	Hachinohe	Aomori
Japan	Hamamatsu Medical Center	Hamamatsu	Shizuoka
Japan	Kawaguchi Respiratory Medicine Clinic	Higashi-osaka	Osaka
Japan	Nakatani Hospital	Himeji	Hyogo
Japan	Hiroshima Allergic & Respiratory Clinic	Hiroshima
Japan	Sakurai Clinic	Hiroshima
Japan	Tsuya Internal Medicine & Respiratory Department Clinic	Hiroshima
Japan	Ikeda City Hospital	Ikeda	Osaka
Japan	Futaba-cho Clinic	Itabashi-ku	Tokyo
Japan	Iwata City Hospital	Iwata	Shizuoka
Japan	National Hospital Organization Tokyo National Hospital	Kiyose	Tokyo
Japan	Kobe City Hospital Organization Kobe City Medical Center West Hospital	Kobe	Hyogo
Japan	Kobe City Medical Center General Hospital	Kobe	Hyogo
Japan	Yamazaki Chest Clinic	Koganei	Tokyo
Japan	Hiramatsu Clinic, Specializing in Internal Medicine, Respiratory Internal Medicine, Asthma, Sleep and Total Care of Rehabilitation in Respiratory in Komaki	Komaki	Aichi
Japan	Ikedo Cardiovascular Medicine Clinic	Kurume	Fukuoka
Japan	Japan Community Health Care Organization Kurume General Hospital	Kurume	Fukuoka
Japan	Kumashiro Hospital	Kurume	Fukuoka
Japan	Tohno Chuo Clinic	Mizunami	Gifu
Japan	Matsushita Memorial Hospital	Moriguchi	Osaka
Japan	Sudo Clinic	Morioka	Iwate
Japan	Jinyu Clinic Hospital	Nakano-ku	Tokyo
Japan	Takagi Hospital	Okawa	Fukuoka
Japan	Omuta Hospital	Omuta	Fukuoka
Japan	Omuta Tenryo Hospital	Omuta	Fukuoka
Japan	Yodogawa Christian Hospital	Osaka
Japan	Senzoku Kokyuuki & Allergy Clinic	Ota-ku	Tokyo
Japan	Saga-ken Medical Centre Koseikan	Saga
Japan	Saitama Red Cross Hospital	Saitama
Japan	Sakaide City Hospital	Sakaide	Kagawa
Japan	Idaimae Minami Yojo Naika Clinic	Sapporo	Hokkaido
Japan	Sendai Medical Center	Sendai	Miyagi
Japan	National Center for Global Health and Medicine	Shinjyuku-ku	Tokyo
Japan	Shizuoka General Hospital	Shizuoka
Japan	The Fraternity Memorial Hospital	Sumida-ku	Tokyo
Japan	Yuizen Clinic	Tachikawa	Tokyo
Japan	Kamei Internal Medicine & Respiratory Clinic	Takamatsu	Kagawa
Japan	Takamatsu Hospital	Takamatsu	Kagawa
Japan	Tsuchiya Clinic	Takasaki	Gunma
Japan	Takatsuki General Hospital	Takatsuki	Osaka
Japan	Takatsuki Red Cross Hospital	Takatsuki	Osaka
Japan	Toyota Memorial Hospital	Toyota	Aichi
Japan	National Hospital Organization Minami-Okayama Medical Center	Tsukubo-gun	Okayama
Japan	Nagata Hospital	Yanagawa	Fukuoka
Japan	Furuie Clinic	Yokohama	Kanagawa
Japan	Kanagawa Cardiovascular and Respiratory Center	Yokohama	Kanagawa
Japan	Saiseikai Yokohama Southern Hospital	Yokohama	Kanagawa
Japan	Yokohama City Minato Red Cross Hospital	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Asthma symptoms	To be evaluated based on Patient diary.	Baseline
Secondary	Use of drugs for the treatment of asthma	To be evaluated from case report form.	Baseline
Secondary	Asthma control during the past 1 week	To be evaluated by Asthma Control Questionare-5 (Japanese Version).	Baseline
Secondary	Asthma control status during the past 1 month	To be evaluated based on Patients' Questionnaire, case report form.	Baseline
Secondary	QOL	To be evaluated by Mini Asthma Quality of Life Questionnaire (Japanese Version)	Baseline
Secondary	Use of drugs for asthma attack and emotional feelings	To be evaluated based on Patients' Questionnaire	Baseline

External Links

•   CSR Synopsis