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

Completed

• Conditions: Asthma

• Registration Number: NCT02640742
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study First Submitted: 2015-12-16
• Study Start: 2015-12-18
• Study First Submitted QC: 2015-12-22
• Study First Posted: 2015-12-29
• Primary Completion: 2016-06-01
• Study Completion: 2016-06-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1232

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary variable is status of asthma control in each patient	Day1 to Day7	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.

Secondary Outcome Measures

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

Trial Locations

Locations (57)

Hiramatsu Clinic, Specializing in Internal Medicine, Respiratory Internal Medicine, Asthma, Sleep and Total Care of Rehabilitation in Respiratory in Komaki; 🇯🇵 Komaki, Aichi, Japan

Toyota Memorial Hospital; 🇯🇵 Toyota, Aichi, Japan

Ken Respiratory & Allergy Clinic; 🇯🇵 Hachinohe, Aomori, Japan

Fukuokaken Saiseikai Futsukaichi Hospital; 🇯🇵 Chikushino, Fukuoka, Japan

Japan Community Health Care Organization Kurume General Hospital; 🇯🇵 Kurume, Fukuoka, Japan

Kumashiro Hospital; 🇯🇵 Kurume, Fukuoka, Japan

Ikedo Cardiovascular Medicine Clinic; 🇯🇵 Kurume, Fukuoka, Japan

Takagi Hospital; 🇯🇵 Okawa, Fukuoka, Japan

Omuta Tenryo Hospital; 🇯🇵 Omuta, Fukuoka, Japan

Omuta Hospital; 🇯🇵 Omuta, Fukuoka, Japan

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