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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031185
Receipt No. R000034678
Scientific Title Investigative cohort analysis of chronic airways disease in older adults with attention to asthma-COPD overlap syndrome: the Prospective Integrative Cohort of Chronic Airways Disease (PIRICA) study
Date of disclosure of the study information 2018/02/20
Last modified on 2020/08/11

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Basic information
Public title Investigative cohort analysis of chronic airways disease in older adults with attention to asthma-COPD overlap syndrome: the Prospective Integrative Cohort of Chronic Airways Disease (PIRICA) study
Acronym PIRICA study
Scientific Title Investigative cohort analysis of chronic airways disease in older adults with attention to asthma-COPD overlap syndrome: the Prospective Integrative Cohort of Chronic Airways Disease (PIRICA) study
Scientific Title:Acronym PIRICA study
Region
Japan

Condition
Condition Asthma, chronic obstructive pulmonary disease (COPD), emphysema, chronic bronchitis
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 1. To define phenotypes of asthma-COPD overlap syndrome (ACOS) based on clinical, physiological, and radiological aspects among chronic airways disease in older adults and to prospectively evaluate clinical course of ACOS
2. To investigate prevalence rate of ACOS among patients with chronic airways disease in older adults
3. To investigate genetic and molecular pathogenesis of chronic airways disease in older adults including ACOS
Basic objectives2 Others
Basic objectives -Others Observational cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Moderate and severe exacerbation* free period and its frequency and annual change in FEV1 during the follow-up period based on clinical phenotypes of ACOS characterized by cluster analysis using clinical, physiological, and radiological parameters

* Exacerbation will be defined as an acute event characterized by a worsening of the patient's respiratory symptoms (at least two of the symptoms of increased dyspnea, change in sputum purulence or increased sputum volume, increased cough, wheezing, or chest tightness) that is beyond day-to-day variations. Moderate exacerbation will be defined as new prescription of antibiotics and/or systemic corticosteroids due to exacerbation. Severe exacerbation will be defined as emergency room visit and/or admission due to exacerbation.
Key secondary outcomes 1. Prevalence rate of ACOS among patients with chronic airways disease in older adults
2. Longitudinal change and comparison among each clinical phenotype of ACOS and non-ACOS (only variables with *) of the following variables
A. Pulmonary function test (pre- and post-bronchodilator spirometry and diffusion capacity)*
B. Assessment of disease control level by ACT and CAT*
C. Assessment of quality of life by AQLQ and SGRQ
D. Level of exhaled nitric oxide*
E. Frequency of reliever drug use*
F. Treatment*
G. Adherence to medications*
H. Comorbidities*
I. Analysis of body composition
J. Three-dementional CT analysis of airways and lung parenchyma
3. Overall survival
4. CT analysis of sinusitis and visceral fat
5. Assessment of biological markers in serum, plasma, urine, and sputum
- Complete blood count
- Inflammatory cytokines
- Adipokines
- Metabolome
6. Analysis of genetic polymorphisms
- Beta2-adrenergic receptor (ADRB2) polymorphism
- Other genetic polymorphisms of biomarker candidates
7. Assessment of gene expression of airway epithelial cells collected by bronchoscopy
- mRNA microarray
- microRNA microarray
8. Pathological analysis of airway biopsy samples
9. Assessment of exosomal microRNA expression in peripheral blood

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
55 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects will be recruited from patients with asthma*, COPD, emphysema**, or chronic bronchitis*** who have been seen or will be seen by respiratory specialists in the participating community hospitals.

* Patients with cough variant asthma should be excluded.
** Emphysema should be diagnosed by the presence of low-attenuation area by CT scan.
*** Chronic bronchitis should be diagnosed by the presence of productive cough that lasts for three months or more per year for at least two years.

Key inclusion criteria (phase I)
1. Clinically stable subjects who do not experience exacerbations requiring prescription change within 30 days before informed consent
2. Age 55 year-old or older
3. Subjects who agree to participate in this study with written informed consent

Key inclusion criteria for detailed examinations (phase II, suspicious of ACOS)
1. Clinically stable subjects with airflow limitation (pre-bronchodilator FEV1/FVC < 0.70) under appropriate therapy and/or emphysema on CT scan at some time during the history
2. Having any of following criteria (at least one item)
A. At least one pattern of symptoms at some time during the history
a. Variation over minutes, hours, or days
b. Worse during the night or early morning
c. Triggered by exercise, emotions including laughter, dust, or exposure to allergens
B. Diagnosis of asthma by a respiratory specialist at some time during the history or at the time of informed consent
C. Eosinophil count in peripheral blood >= 300 cells / mm3 in the past
D. Increased response to bronchodilator: FEV1 increase >= 200 ml and >= 12% in the past
E. Positive specific IgE for any of inhaled antigen or total IgE > 100 IU in the past
3. Subjects who agree with detailed examinations at Hokkaido University Hospital
Key exclusion criteria 1. Any kind of active respiratory infections including tuberculosis
2. Thoracic deformity which would influence pulmonary function tests
3. Any kind of malignant diseases in whom 3 year's follow-up would not be possible
4. History of lung resection
5. Any kind of pulmonary diseases including cystic fibrosis (CF), non-CF bronchiectasis, hypersensitivity pneumonitis, pulmonary fibrosis, secondary bronchiolitis obliterans, and others
6. Difficulty in performing pulmonary function tests due to dementia or other serious diseases
7. Deficient in alpha-1 antitrypsin
8. Judged to be inappropriate subjects for any reasons by principle investigators
Target sample size 1125

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Konno
Organization Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name Department of Respiratory Medicine
Zip code 060-8638
Address North 15 West 7, Kita-ku, Sapporo 060-8638, Japan
TEL 011-706-5911
Email satkonno@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Masaru
Middle name
Last name Suzuki
Organization Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name Department of Respiratory Medicine
Zip code 060-8638
Address North 15 West 7, Kita-ku, Sapporo 060-8638, Japan
TEL 011-706-5911
Homepage URL
Email suzumasa@med.hokudai.ac.jp

Sponsor
Institute Department of Respiratory Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Institute
Department

Funding Source
Organization Novartis Pharma K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Hokkaido Research Institute for Respiratory Diseases
Name of secondary funder(s) Japan Society for the Promotion of Science

IRB Contact (For public release)
Organization The ethics committee of Hokkaido University Hospital
Address North 14 West 5, Kita-ku, Sapporo 060-8648, Japan
Tel 011-706-7636
Email crjimu@huhp.hokudai.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 北海道大学病院(北海道)、KKR札幌医療センター(北海道)、JCHO北海道病院(北海道)、国立病院機構北海道医療センター(北海道)、市立札幌病院(北海道)、北海道社会事業協会小樽病院(北海道)、医療法人社団憲仁会牧田病院(北海道)、帯広厚生病院(北海道)、勤医協中央病院(北海道)、たかはし内科・呼吸器内科クリニック(北海道)、王子総合病院(北海道)、国立病院機構函館病院(北海道)

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 11 Month 17 Day
Date of IRB
2017 Year 11 Month 17 Day
Anticipated trial start date
2018 Year 03 Month 26 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study.
Register the patients who meet registration criteria, and follow-up their clinical course for 3 years.

Management information
Registered date
2018 Year 02 Month 07 Day
Last modified on
2020 Year 08 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034678

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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