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Periostin and Treatment Responsiveness in Asthma: A Prospective Cohort Study with Imaging-Based Airway Remodeling Assessment and PAI-1 Promoter Polymorphism Analysis

Periostin Levels in Blood and Sputum and Their Relationship to Treatment Response in Bronchial Asthma: A Prospective Observational Study with Exploratory Analysis of PAI-1 Gene Variant

Fukahori Susumu

Nagasaki University Hospital

1-7-1, Sakamoto, Nagasaki-shi, Nagasaki-ken, Japan, 852-8501

susumu-f@nagasaki-u.ac.jp

Fukahori Susumu

Nagasaki University Hospital

1-7-1, Sakamoto, Nagasaki-shi, Nagasaki-ken, Japan, 852-8501

+81-95-819-7273

susumu-f@nagasaki-u.ac.jp

Pending

Jan. 07, 2026

Observational

non-randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Patients diagnosed with bronchial asthma.

Patients meeting the criteria for moderate-to-severe persistent asthma according to JGL 2024.

Adults aged 18 years or older who regularly attend the outpatient clinic of the Department of Respiratory Medicine, Nagasaki University Hospital.

Patients who have received high-dose inhaled corticosteroid (ICS)-based therapy (in combination with LABA, LAMA, LTRA and or biologic agents, as applicable) during the period from 1 September 2025 to 31 March 2027.

Patients who are able to provide written informed consent.

1. Patients with a diagnosis of chronic lung disease other than asthma, such as chronic obstructive pulmonary disease (COPD) or diffuse interstitial lung disease.
2. Patients who are pregnant or breastfeeding.
3. Patients with terminal malignancy or progressive severe systemic disease (e.g., severe heart failure, end-stage renal disease on dialysis).
4. Patients who are unable to provide consent due to a strong aversion or fear of blood sampling and/or genetic testing.
5. Patients deemed inappropriate for study participation by the attending physician or the principal investigator (e.g., expected difficulty in cooperation/adherence).

Asthma

bronchial asthma, moderate-to-severe persistent asthma, airway remodeling, periostin, HRCT, FeNO, ACT, exacerbation, PAI-1 polymorphism (4G/5G)

D001249

Change in WA percent on HRCT from baseline (T0) to 12 months (T12).

Change in serum periostin from baseline (T0) to 12 months (T12), using natural log transformed values.

ACT score at T0, T6, and T12.

Spirometric indices (including FEV1) at T0, T6, and T12.

FeNO at T0, T6, and T12.

Serum periostin and sputum periostin at T0, T6, and T12.

Airway hyperresponsiveness measured by Astograph at prespecified time points (indices include Dmin, PD15Grs, PD35Grs, and SGrs).

HRCT airway imaging metrics at T0 and T12, including WA percent, WT percent, lumen area, WA to LA ratio, lumen diameter, lumen circularity, WA percent adjusted for BSA, WT percent adjusted for BSA, mucus plugging score (MPS), and total small airway count (TAC).

Exploratory analyses:
(a) feasibility of estimating HRCT airway metrics using chest X ray based airway wall thickness and periostin levels, and
(b) association of PAI 1 promoter polymorphism (rs1799768, 4G or 5G) with serum periostin and sputum periostin, and with imaging and physiologic phenotypes (genotype biomarker phenotype relationships).

+81-95-819-7229

No

What IPD will be shared? De-identified participant-level data linked only by study ID (no direct identifiers). Data include primary/secondary outcomes and relevant covariates (e.g., ACT, FeNO, lung function, serum/sputum periostin, imaging indices, airway hyperresponsiveness indices, PAI-1 genotype, age, sex, BMI, smoking history, treatment variables). A data dictionary/codebook will be provided. Raw imaging files (e.g., DICOM) will not be shared in principle. When will IPD be shared? After completion of primary analyses and public dissemination (publication/presentation), typically within 6 months after dissemination. With whom will IPD be shared and how? With the collaborating institution(s) and qualified researchers/institutions approved by the principal investigator, upon submission/review of a proposal, completion of required ethical checks, and execution of a data use agreement. Data will be transferred securely (password-protected files; password provided via separate channel). Redistribution and non-approved use are prohibited. For how long will IPD be shared? For 5 years after dissemination (or within the data retention period).

none