UMIN-CTR Clinical Trial

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

Asthma, chronic obstructive pulmonary disease (COPD), emphysema, chronic bronchitis

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

YES

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Novartis Pharma K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Hokkaido Research Institute for Respiratory Diseases

Name of secondary funder(s)

Japan Society for the Promotion of Science

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2018

Year

02

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

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

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/ctr_e/ctr_view.cgi?recptno=R000034678