A prospective cohort study of asthma and COPD overlap in Japanese COPD patients using the diagnostic criteria of The Japanese Respiratory Society - ACO-Registry

Study identifier:D5980R00005

ClinicalTrials.gov identifier:NCT03577795

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A prospective cohort study of asthma and COPD overlap in Japanese COPD patients using the diagnostic criteria of The Japanese Respiratory Society

Medical condition

Pulmonary Disease, Chronic Obstructive

Phase

N/A

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

710

Study type

Observational

Age

N/A

Date

Study Start Date: 19 Jun 2018

Primary Completion Date: 19 Feb 2021

Study Completion Date: 19 Feb 2021

Study design

Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Jan 2022 by AstraZeneca

Collaborators

Linical Co.,Ltd.

Inclusion and exclusion criteria

Inclusion Criteria

1. Patients from whom written consent to participate in this study has been obtained
2. Patients ≥40 years old
3. Patients with FEV1/FVC ratio <70% after bronchodilator inhalation within the past year or on the registrationa
4. Patients who satisfy any one of the following items:
1) Smoking history (≥10 pack-years) or comparable air pollution exposure on the registrationa
2) Presence of the low attenuation area on chest CT demonstrating emphysematous alteration within the past year or on the registration a,b,
3) Impaired pulmonary diffusing capacity (%DLCO <80% or %DLCO/VA <80%) within the past year or on the registrationa
4) Patients deemed capable of visiting their study center in Japan at least once a year on an outpatient basis

Exclusion Criteria

1. Patients who participated in other interventional studies such as clinical trial within the last 8 weeks.
2. Patients who are unsuitable for their enrollment in this study, judged by the participating physician, because they cannot comply with the procedures, restrictions, and requirements of this study (e.g., patients with dementia).
3. Patients with exacerbationsa of COPD or asthma within the last 8 weeks.
a COPD exacerbation: State of increased shortness of breathing, increased cough and sputum, and occurrence or exacerbation of chest discomfort that requires a change of treatment during the stable phase. However, exacerbation preceded by other disorders (e.g., heart failure, pneumothorax, pulmonary thromboembolism) is excluded.
Asthma exacerbation: Occurrence of paroxysmal/variable cough/sputum/wheezing/dyspnea caused by various factors including respiratory infection.
4. Patients carrying following disorders that should be distinguished from COPD or asthma:
Diffuse panbronchiolitis, congenital sinobronchial syndrome, occlusive panbronchiolitis, bronchiectasis, pulmonary tuberculosis, pneumoconiosis, lymphangioleiomyomatosis, congestive heart failure, interstitial lung disease, lung cancer, laryngitis, epiglottitis, vocal cord dysfunction, intratracheal tumor, airway foreign substance, tracheomalacia, bronchial tuberculosis, pulmonary thromboembolism, cough induced by drug such as angiotensin-converting enzyme inhibitor, spontaneous pneumothorax, hyperventilation syndrome, psychogenic cough

No locations available

Arms	Assigned Interventions

Documents available

CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Masakazu Ichinose

Tohoku University School of Medicine