AsthmaACQUIRE-2NCT02640742
Asthma Control, Quality of Life and Emotional Feelings in a Real Life Setting
An observational study of Asthma, run by AstraZeneca at 57 sites in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Asthma
- How many people
- 1,232 participants
- Where
- 57 sitesJapan
- Study dates
- 18 Dec 2015to 1 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult asthma patients receiving continued treatment by physician in Japan
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
57 sites in 1 country.
57 sites in 1 country
Japan57 sites
Fukuokaken Saiseikai Futsukaichi Hospital
Chikushino-shi, Fukuoka, 818-8516
Nihonbashi Medical & Allergy Clinic
Cyuo-ku, Tokyo, 103-0022
Fujita General Hospital
Date-gun, Fukushima, 969-1793
Fujisawa City Hospital
Fujisawa, Kanagawa, 251-8550
National Hospital Organization Fukuoka-Higashi Medical Center
Fukuoka, Koga, 811-3195
Hamanomachi Hospital
Fukuoka, 810-8539
Fukuoka Sanno Hospital
Fukuoka, 814-0001
Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers
Fukuoka, 815-8588
Ohara General Hospital
Fukushima, 960-8611
Ken Respiratory & Allergy Clinic
Hachinohe, Aomori, 031-0011
Hamamatsu Medical Center
Hamamatsu, Shizuoka, 432-8580
Kawaguchi Respiratory Medicine Clinic
Higashiosaka, Osaka, 577-0843
Nakatani Hospital
Himeji, Hyōgo, 672-8064
Sakurai Clinic
Hiroshima, 731-0103
Hiroshima Allergic & Respiratory Clinic
Hiroshima, 732-0052
Tsuya Internal Medicine & Respiratory Department Clinic
Hiroshima, 732-0062
Ikeda City Hospital
Ikeda, Osaka, 563-8510
Iwata City Hospital
Iwata, Shizuoka, 438-8550
National Hospital Organization Tokyo National Hospital
Kiyose, Tokyo, 204-8585
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047
Kobe City Hospital Organization Kobe City Medical Center West Hospital
Kobe, Hyōgo, 653-0013
Yamazaki Chest Clinic
Koganei, Tokyo, 184-0003
Hiramatsu Clinic, Specializing in Internal Medicine, Respiratory Internal Medicine, Asthma, Sleep and Total Care of Rehabilitation in Respiratory in Komaki
Komaki, Aichi-ken, 485-0041
Japan Community Health Care Organization Kurume General Hospital
Kurume, Fukuoka, 830-0013
Kumashiro Hospital
Kurume, Fukuoka, 830-1101
Ikedo Cardiovascular Medicine Clinic
Kurume, Fukuoka, 839-1204
Tohno Chuo Clinic
Mizunami, Gifu, 509-6134
Matsushita Memorial Hospital
Moriguchi, Osaka, 570-8540
Sudo Clinic
Morioka, Iwate, 020-0045
Jinyu Clinic Hospital
Nakano-ku, Tokyo, 164-0012
Takagi Hospital
Ōkawa, Fukuoka, 831-0016
Omuta Tenryo Hospital
Omuta, Fukuoka, 836-8566
Omuta Hospital
Omuta, Fukuoka, 837-0911
Yodogawa Christian Hospital
Osaka, 533-0024
Senzoku Kokyuuki & Allergy Clinic
Ōta-ku, Tokyo, 145-0063
Saga-ken Medical Centre Koseikan
Saga, 840-8571
Saitama Red Cross Hospital
Saitama, 338-8553
Sakaide City Hospital
Sakaidechō, Kagawa-ken, 762-8550
Idaimae Minami Yojo Naika Clinic
Sapporo, Hokkaido, 064-0804
Sendai Medical Center
Sendai, Miyagi, 983-8520
National Center for Global Health and Medicine
Shinjyuku-ku, Tokyo, 162-8655
Shizuoka General Hospital
Shizuoka, 420-8527
The Fraternity Memorial Hospital
Sumida-ku, Tokyo, 130-8587
Futaba-cho Clinic
tabashi City, Tokyo, 173-0011
Yuizen Clinic
Tachikawa, Tokyo, 190-0013
Takamatsu Hospital
Takamatsu, Kagawa-ken, 760-0018
Kamei Internal Medicine & Respiratory Clinic
Takamatsu, Kagawa-ken, 761-8073
Tsuchiya Clinic
Takasaki, Gunma, 370-0006
Takatsuki Red Cross Hospital
Takatsuki, Osaka, 569-1045
Takatsuki General Hospital
Takatsuki, Osaka, 569-1192
Toyota Memorial Hospital
Toyota, Aichi-ken, 471-8513
National Hospital Organization Minami-Okayama Medical Center
Tsukubo-gun, Okayama-ken, 701-0304
Nagata Hospital
Yanagawa, Fukuoka, 832-0059
Yokohama City Minato Red Cross Hospital
Yokohama, Kanagawa, 231-8682
Furuie Clinic
Yokohama, Kanagawa, 233-0013
Saiseikai Yokohama Southern Hospital
Yokohama, Kanagawa, 234-0054
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Kanagawa, 236-0051
About this study
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
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.
Read the 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
- 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.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day1 to Day7
Secondary outcomes (6)
Asthma symptoms
To be evaluated based on Patient diary.
Measured: Baseline
Use of drugs for the treatment of asthma
To be evaluated from case report form.
Measured: Baseline
Asthma control during the past 1 week
To be evaluated by Asthma Control Questionare-5 (Japanese Version).
Measured: Baseline
Asthma control status during the past 1 month
To be evaluated based on Patients' Questionnaire, case report form.
Measured: Baseline
QOL
To be evaluated by Mini Asthma Quality of Life Questionnaire (Japanese Version)
Measured: Baseline
Use of drugs for asthma attack and emotional feelings
To be evaluated based on Patients' Questionnaire
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study start18 Dec 2015
- Primary completion1 Jun 2016
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,232 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitsuru Adachi, MD, PhD, Professor, Principal investigator, International University of Health and WelfareGen Tamura, MD, PhD, President, Principal investigator, Airway Institute in Sendai Co., LtdMasanori Nishikawa, DM, PhD, Principal investigator, Department of Respiratory Medicine, Fujisawa City HospitalSoichiro Hozawa, MD, Principal investigator, Hiroshima Allergy and Respiratory Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640742
- Sponsor's protocol ID
- D2287R00101
- Acronym
- ACQUIRE-2
- Status last verified
- Oct 2017
- First submitted
- 16 Dec 2015
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02640742
- Acronym / sponsor ID
- ACQUIRE-2 / D2287R00101
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,232 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2015 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult asthma patients receiving continued treatment by physician in Japan
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Asthma symptoms
Time frame: Baseline
Use of drugs for the treatment of asthma
Time frame: Baseline
Asthma control during the past 1 week
Time frame: Baseline
Asthma control status during the past 1 month
Time frame: Baseline
QOL
Time frame: Baseline
Use of drugs for asthma attack and emotional feelings
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- CSR SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitsuru Adachi, MD, PhD, Professor principal investigator
International University of Health and Welfare
Gen Tamura, MD, PhD, President principal investigator
Airway Institute in Sendai Co., Ltd
Masanori Nishikawa, DM, PhD principal investigator
Department of Respiratory Medicine, Fujisawa City Hospital
57 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by AstraZeneca at 57 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary variable is status of asthma control in each patient (time frame: Day1 to Day7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.