Asthma Control, Quality of Life and Emotional Feelings in a Real Life Setting (ACQUIRE-2)

Asthma Control, Quality of Life and Emotional Feelings in a Real Life Setting-A Cross-sectional Study of Adult Asthma Patients in Japan

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.

Study Overview

• Status: Completed
• Conditions: Asthma

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.

• Study Type: Observational
• Enrollment (Actual): 1232

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 815-8588
    • Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers
  • Fukuoka, Japan, 810-8539
    • Hamanomachi Hospital
  • Fukuoka, Japan, 814-0001
    • Fukuoka Sanno Hospital
  • Fukushima, Japan, 960-8611
    • Ohara General Hospital
  • Hiroshima, Japan, 731-0103
    • Sakurai Clinic
  • Hiroshima, Japan, 732-0052
    • Hiroshima Allergic & Respiratory Clinic
  • Hiroshima, Japan, 732-0062
    • Tsuya Internal Medicine & Respiratory Department Clinic
  • Osaka, Japan, 533-0024
    • Yodogawa Christian Hospital
  • Saga, Japan, 840-8571
    • Saga-ken Medical Centre Koseikan
  • Saitama, Japan, 338-8553
    • Saitama Red Cross Hospital
  • Shizuoka, Japan, 420-8527
    • Shizuoka General Hospital
  • Aichi
    • Komaki, Aichi, Japan, 485-0041
      • Hiramatsu Clinic, Specializing in Internal Medicine, Respiratory Internal Medicine, Asthma, Sleep and Total Care of Rehabilitation in Respiratory in Komaki
    • Toyota, Aichi, Japan, 471-8513
      • Toyota Memorial Hospital
  • Aomori
    • Hachinohe, Aomori, Japan, 031-0011
      • Ken Respiratory & Allergy Clinic
  • Fukuoka
    • Chikushino, Fukuoka, Japan, 818-8516
      • Fukuokaken Saiseikai Futsukaichi Hospital
    • Kurume, Fukuoka, Japan, 830-0013
      • Japan Community Health care Organization Kurume General Hospital
    • Kurume, Fukuoka, Japan, 830-1101
      • Kumashiro Hospital
    • Kurume, Fukuoka, Japan, 839-1204
      • Ikedo Cardiovascular Medicine Clinic
    • Okawa, Fukuoka, Japan, 831-0016
      • Takagi Hospital
    • Omuta, Fukuoka, Japan, 836-8566
      • Omuta Tenryo Hospital
    • Omuta, Fukuoka, Japan, 837-0911
      • Omuta Hospital
    • Yanagawa, Fukuoka, Japan, 832-0059
      • Nagata Hospital
  • Fukushima
    • Date-gun, Fukushima, Japan, 969-1793
      • Fujita General Hospital
  • Gifu
    • Mizunami, Gifu, Japan, 509-6134
      • Tohno Chuo Clinic
  • Gunma
    • Takasaki, Gunma, Japan, 370-0006
      • Tsuchiya Clinic
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 064-0804
      • Idaimae Minami Yojo Naika Clinic
  • Hyogo
    • Himeji, Hyogo, Japan, 672-8064
      • Nakatani Hospital
    • Kobe, Hyogo, Japan, 650-0047
      • Kobe City Medical Center General Hospital
    • Kobe, Hyogo, Japan, 653-0013
      • Kobe City Hospital Organization Kobe City Medical Center West Hospital
  • Iwate
    • Morioka, Iwate, Japan, 020-0045
      • Sudo Clinic
  • Kagawa
    • Sakaide, Kagawa, Japan, 762-8550
      • Sakaide City Hospital
    • Takamatsu, Kagawa, Japan, 760-0018
      • Takamatsu Hospital
    • Takamatsu, Kagawa, Japan, 761-8073
      • Kamei Internal Medicine & Respiratory Clinic
  • Kanagawa
    • Fujisawa, Kanagawa, Japan, 251-8550
      • Fujisawa City Hospital
    • Yokohama, Kanagawa, Japan, 231-8682
      • Yokohama City Minato Red Cross Hospital
    • Yokohama, Kanagawa, Japan, 236-0051
      • Kanagawa Cardiovascular and Respiratory Center
    • Yokohama, Kanagawa, Japan, 233-0013
      • Furuie Clinic
    • Yokohama, Kanagawa, Japan, 234-0054
      • Saiseikai Yokohama Southern Hospital
  • Koga
    • Fukuoka, Koga, Japan, 811-3195
      • National Hospital Organization Fukuoka-Higashi Medical Center
  • Miyagi
    • Sendai, Miyagi, Japan, 983-8520
      • Sendai Medical Center
  • Okayama
    • Tsukubo-gun, Okayama, Japan, 701-0304
      • National Hospital Organization Minami-Okayama Medical Center
  • Osaka
    • Higashi-osaka, Osaka, Japan, 577-0843
      • Kawaguchi Respiratory Medicine Clinic
    • Ikeda, Osaka, Japan, 563-8510
      • Ikeda City Hospital
    • Moriguchi, Osaka, Japan, 570-8540
      • Matsushita Memorial Hospital
    • Takatsuki, Osaka, Japan, 569-1045
      • Takatsuki Red Cross Hospital
    • Takatsuki, Osaka, Japan, 569-1192
      • Takatsuki General Hospital
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 432-8580
      • Hamamatsu Medical Center
    • Iwata, Shizuoka, Japan, 438-8550
      • Iwata City Hospital
  • Tokyo
    • Cyuo-ku, Tokyo, Japan, 103-0022
      • Nihonbashi Medical & Allergy Clinic
    • Itabashi-ku, Tokyo, Japan, 173-0011
      • Futaba-cho Clinic
    • Kiyose, Tokyo, Japan, 204-8585
      • National Hospital Organization Tokyo National Hospital
    • Koganei, Tokyo, Japan, 184-0003
      • Yamazaki Chest Clinic
    • Nakano-ku, Tokyo, Japan, 164-0012
      • Jinyu Clinic Hospital
    • Ota-ku, Tokyo, Japan, 145-0063
      • Senzoku Kokyuuki & Allergy Clinic
    • Shinjyuku-ku, Tokyo, Japan, 162-8655
      • National Center for Global Health and Medicine
    • Sumida-ku, Tokyo, Japan, 130-8587
      • The Fraternity Memorial Hospital
    • Tachikawa, Tokyo, Japan, 190-0013
      • Yuizen Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult asthma patients receiving continued treatment by physician in Japan

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: 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

Publications and helpful links

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: December 16, 2015
• First Submitted That Met QC Criteria: December 22, 2015
• First Posted (Estimate): December 29, 2015

Study Record Updates

• Last Update Posted (Actual): October 25, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: D2287R00101