NOVELTY-CT sub-study Observational study to evaluate associations between CT features and patients characteristics of obstructive respiratory diseases (Asthma and/or COPD) in the Japanese subjects recruited in the NOVELTY

JRCT ID: jRCT1030230001

Registered date:02/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: asthma and/or COPD
• Date of first enrollment: 20/03/2023
• Target sample size: 300
• Study type: Observational

Outcome(s)

• Primary Outcome: Baseline demographic and clinical characteristics for +/- emphysema patients.
• Secondary Outcome: Changes during 3 yearly follow-up in key clinical characteristics for +/- emphysema patients

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Enrolled in the main NOVELTY study from Japan study sites
2. Have available clinical data NOVELTY study database (ie patients must be included in the analysis set)
3. Able to sign written, informed consent (or having a responsible, legally authorized representative acting on patients behalf)
4. Have available chest CT image at baseline (within 1 year before the date of at least one visit of NOVELTY study)

• Exclude criteria: No exclusion criterion in this study

Related Information

• Primary Sponsor: Tashiro Naoki
• Secondary Sponsor: AstraZeneca