Asthma Control, Quality of Life and Emotional Feelings in a Real Life Setting (ACQUIRE-2)
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| ClinicalTrials.gov Identifier: NCT02640742 |
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Recruitment Status :
Completed
First Posted : December 29, 2015
Last Update Posted : October 25, 2017
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| Condition or disease |
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| Asthma |
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
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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").
- 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 |
| Actual Enrollment : | 1232 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Cross-Sectional |
| 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 |
| Actual Study Start Date : | December 18, 2015 |
| Actual Primary Completion Date : | June 1, 2016 |
| Actual Study Completion Date : | June 1, 2016 |
- The primary variable is status of asthma control in each patient [ Time Frame: 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.
- Asthma symptoms [ Time Frame: Baseline ]To be evaluated based on Patient diary.
- Use of drugs for the treatment of asthma [ Time Frame: Baseline ]To be evaluated from case report form.
- Asthma control during the past 1 week [ Time Frame: Baseline ]To be evaluated by Asthma Control Questionare-5 (Japanese Version).
- Asthma control status during the past 1 month [ Time Frame: Baseline ]To be evaluated based on Patients' Questionnaire, case report form.
- QOL [ Time Frame: Baseline ]To be evaluated by Mini Asthma Quality of Life Questionnaire (Japanese Version)
- Use of drugs for asthma attack and emotional feelings [ Time Frame: Baseline ]To be evaluated based on Patients' Questionnaire
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 20 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02640742
Show 57 study locations
| 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 |
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT02640742 |
| Other Study ID Numbers: |
D2287R00101 |
| First Posted: | December 29, 2015 Key Record Dates |
| Last Update Posted: | October 25, 2017 |
| Last Verified: | October 2017 |
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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |