Obstructive Respiratory Disease Phenotyping and Endotyping Study (TheTRAIT Study) in Japan.

Not Applicable

Completed

• Conditions: Asthma, Chronic Obstructive Pulmonary Disease (COPD), Asthma-COPD Overlap

• Registration Number: JPRN-jRCT1080224767
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

1. Participant must be 40 to 80 years of age inclusive at the time of signing the informed consent form (ICF).

2. Participant must have either:
(A) Asthma Cohort: A physician's diagnosis of asthma and be a regular user of inhaled corticosteroid (ICS) maintenance medication.
(B) ACO Cohort: A physician's diagnosis of ACO and be a regular user of long acting muscarinic antagonist (LAMA) and/or long-acting beta-agonist (LABA) and/or ICS maintenance medication.
(C) COPD Cohort: A physician's diagnosis of COPD and be a regular user of LAMA and/or LABA maintenance medication.

3. Participant may be male or female.

4. Participant must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Furthermore, adaptive inclusion criteria will be used in order to ensure that a substantial proportion of the study population presents with significant obstructive respiratory disease.

In Asthma Cohort:
5. At least 50% of participants must be using an ICS/LABA at Screening.

In ACO Cohort and COPD Cohort
6. At least 75% of participants must have a post bronchodilator FEV1/FVC less than 0.7 at Visit 1.
AND
7. At least 60% of participants must have experienced an event in the 24 months prior to Screening, where an event includes symptoms of respiratory tract infection requiring antibiotics and/or systemic corticosteroids, exacerbation and asthma attacks.
8. Otherwise (if No.7 is not met), the participants must meet the definition of unstable COPD, as described below:
(a) Shortness of breath despite using ICS/LABA medication.
(b) Symptoms (such as cough, sputum or shortness of breath) and/or a worsening of symptoms despite using LAMA, LAMA/LABA or ICS/LAMA/LABA medication.

Exclusion Criteria

1. Participant has undergone major lung surgery (e.g. lung reduction, lobectomy, or lung transplant).
2. Participant has a known history of significant inflammatory disease other than COPD (e.g. rheumatoid arthritis or lupus) (ACO Cohort and COPD Cohort only).
3. Participant has serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study or impact on participant safety.
4. Participant has been diagnosed with cancer within the last 5 years (participants in remission for 5 years or more are eligible).
5. Participant has a current primary diagnosis of diffuse pan-bronchiolitis, or a primary diagnosis of bronchiectasis or pulmonary fibrosis.
6. Participant only has a diagnosis of chronic bronchitis or pulmonary emphysema and demonstrate no spirometric evidence of obstructive lung disease.
7. Participant is currently participating in another study involving investigational study treatment intervention. Note: If, while enrolled in the present study, the participant enrols in such studies, they will be withdrawn from the present study.
8. Participant is unable to perform spirometry, due to, for example, recent eye surgery or thoracic or abdominal surgery, unstable cardiovascular status, recent myocardial infarction or pulmonary embolism or an allergy to SABAs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
other<br>The proportion of participants presenting with combinations of clinical characteristics, including but not limited to: <br>Example 1: Participants with 30% or more and less than 85% of pre-bronchodilator FEV1, airway reversibility, at least one event in the 24 months prior to Visit 1, 1.5 or more of ACQ-5 score. <br>Example 2: Participants with a smoking history, less than 0.7 of post-bronchodilator FEV1/FVC, at least one event in the 24 months prior to Visit 1, 10 or more of CAAT score, and 100 cells/uL or more of peripheral blood eosinophil.