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

NCT02640742 | Completed

• 1 other identifier: D2287R00101
• Study Type: observational
• Target: 1,232
• Locations: 1 country
• Sites: 57

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Asthma symptoms

  Baseline

• Use of drugs for the treatment of asthma

  Baseline

• Asthma control during the past 1 week

  Baseline

• Asthma control status during the past 1 month

  Baseline

• QOL

  Baseline

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult asthma patients receiving continued treatment by physician in Japan

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (57)

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

Location

Toyota Memorial Hospital

Toyota, Aichi-ken, 471-8513, Japan

Location

Ken Respiratory & Allergy Clinic

Hachinohe, Aomori, 031-0011, Japan

Location

Fukuokaken Saiseikai Futsukaichi Hospital

Chikushino-shi, Fukuoka, 818-8516, Japan

Location

Japan Community Health Care Organization Kurume General Hospital

Kurume, Fukuoka, 830-0013, Japan

Location

Kumashiro Hospital

Kurume, Fukuoka, 830-1101, Japan

Location

Ikedo Cardiovascular Medicine Clinic

Kurume, Fukuoka, 839-1204, Japan

Location

Omuta Tenryo Hospital

Omuta, Fukuoka, 836-8566, Japan

Location

Omuta Hospital

Omuta, Fukuoka, 837-0911, Japan

Location

Takagi Hospital

Ōkawa, Fukuoka, 831-0016, Japan

Location

Nagata Hospital

Yanagawa, Fukuoka, 832-0059, Japan

Location

Fujita General Hospital

Date-gun, Fukushima, 969-1793, Japan

Location

Tohno Chuo Clinic

Mizunami, Gifu, 509-6134, Japan

Location

Tsuchiya Clinic

Takasaki, Gunma, 370-0006, Japan

Location

Idaimae Minami Yojo Naika Clinic

Sapporo, Hokkaido, 064-0804, Japan

Location

Nakatani Hospital

Himeji, Hyōgo, 672-8064, Japan

Location

Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0047, Japan

Location

Kobe City Hospital Organization Kobe City Medical Center West Hospital

Kobe, Hyōgo, 653-0013, Japan

Location

Sudo Clinic

Morioka, Iwate, 020-0045, Japan

Location

Sakaide City Hospital

Sakaidechō, Kagawa-ken, 762-8550, Japan

Location

Takamatsu Hospital

Takamatsu, Kagawa-ken, 760-0018, Japan

Location

Kamei Internal Medicine & Respiratory Clinic

Takamatsu, Kagawa-ken, 761-8073, Japan

Location

Fujisawa City Hospital

Fujisawa, Kanagawa, 251-8550, Japan

Location

Yokohama City Minato Red Cross Hospital

Yokohama, Kanagawa, 231-8682, Japan

Location

Furuie Clinic

Yokohama, Kanagawa, 233-0013, Japan

Location

Saiseikai Yokohama Southern Hospital

Yokohama, Kanagawa, 234-0054, Japan

Location

Kanagawa Cardiovascular and Respiratory Center

Yokohama, Kanagawa, 236-0051, Japan

Location

National Hospital Organization Fukuoka-Higashi Medical Center

Fukuoka, Koga, 811-3195, Japan

Location

Sendai Medical Center

Sendai, Miyagi, 983-8520, Japan

Location

National Hospital Organization Minami-Okayama Medical Center

Tsukubo-gun, Okayama-ken, 701-0304, Japan

Location

Kawaguchi Respiratory Medicine Clinic

Higashiosaka, Osaka, 577-0843, Japan

Location

Ikeda City Hospital

Ikeda, Osaka, 563-8510, Japan

Location

Matsushita Memorial Hospital

Moriguchi, Osaka, 570-8540, Japan

Location

Takatsuki Red Cross Hospital

Takatsuki, Osaka, 569-1045, Japan

Location

Takatsuki General Hospital

Takatsuki, Osaka, 569-1192, Japan

Location

Hamamatsu Medical Center

Hamamatsu, Shizuoka, 432-8580, Japan

Location

Iwata City Hospital

Iwata, Shizuoka, 438-8550, Japan

Location

Nihonbashi Medical & Allergy Clinic

Cyuo-ku, Tokyo, 103-0022, Japan

Location

Futaba-cho Clinic

Itabashi-ku, Tokyo, 173-0011, Japan

Location

National Hospital Organization Tokyo National Hospital

Kiyose, Tokyo, 204-8585, Japan

Location

Yamazaki Chest Clinic

Koganei, Tokyo, 184-0003, Japan

Location

Jinyu Clinic Hospital

Nakano-ku, Tokyo, 164-0012, Japan

Location

Senzoku Kokyuuki & Allergy Clinic

Ōta-ku, Tokyo, 145-0063, Japan

Location

National Center for Global Health and Medicine

Shinjyuku-ku, Tokyo, 162-8655, Japan

Location

The Fraternity Memorial Hospital

Sumida-ku, Tokyo, 130-8587, Japan

Location

Yuizen Clinic

Tachikawa, Tokyo, 190-0013, Japan

Location

Hamanomachi Hospital

Fukuoka, 810-8539, Japan

Location

Fukuoka Sanno Hospital

Fukuoka, 814-0001, Japan

Location

Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers

Fukuoka, 815-8588, Japan

Location

Ohara General Hospital

Fukushima, 960-8611, Japan

Location

Sakurai Clinic

Hiroshima, 731-0103, Japan

Location

Hiroshima Allergic & Respiratory Clinic

Hiroshima, 732-0052, Japan

Location

Tsuya Internal Medicine & Respiratory Department Clinic

Hiroshima, 732-0062, Japan

Location

Yodogawa Christian Hospital

Osaka, 533-0024, Japan

Location

Saga-ken Medical Centre Koseikan

Saga, 840-8571, Japan

Location

Saitama Red Cross Hospital

Saitama, 338-8553, Japan

Location

Shizuoka General Hospital

Shizuoka, 420-8527, Japan

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 29, 2015
• Study Start: December 18, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 25, 2017

Record last verified: 2017-10

Locations

JP (57)