UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000031185
Receipt number 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 17:44:52

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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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