Small Airway Obstruction in Asthma, COPD, ACOS

Completed

• Conditions: Asthma; COPD; Asthma-COPD Overlap Syndrome
• Interventions: Other: No any intervention

• Registration Number: NCT03423693
• Lead Sponsor: Mahidol University

Brief Summary

This study was designed as retrospective chart review to test our hypothesis whether there are the differences in inflammatory and anti-inflammatory mediators between asthmatic and ACOS patients with small airway obstruction, and COPD

Detailed Description

The data including spirometry, lung volume, impulse oscillometry, sputum data, demographic characters within 6 months are collected for later analysis. Sputum supernatants and cytospins are used to determine inflammatory and anti-inflammatory responses in those patients.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-01-10
• Study First Submitted: 2018-01-30
• Study First Submitted QC: 2018-02-05
• Study First Posted: 2018-02-06
• Primary Completion: 2020-07-31
• Study Completion: 2020-12-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-16
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• Physician-diagnosed asthma, ACO, and COPD
• Their spirometric, IOS, lung volume, demographic data and sputum samples are available

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Exclusion Criteria

• Concomitant diseases requiring immunosuppressive therapy
• Being on treatments with NSAIDs, macrolides, statins

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Asthma with SAO-	No any intervention	Asthmatic patients with RV/TLC \< 40
ACO	No any intervention	Asthmatic patients with smoking \> or = 10 pack years who have persistent airway obstruction (post-BD FEV1/FVC \< 0.7) or COPD patients who have bronchodilator (BD) reversibility (absolute increase in FEV1 \> or = 200 ml and FEV1% \> or =12% after BD)
COPD	No any intervention	Patients with history of smoking \> or = 10 pack year with post-BD FEV1/FVC \< 0.7 and negative BD reversibility (absolute increase in FEV1 \< 200 ml and FEV1% \<12% after BD)
Asthma with SAO+	No any intervention	Asthmatic patients with RV/TLC \> or = 40

Primary Outcome Measures

Name	Time	Method
Lipoxin A4, ,	1 day (single time point)	Lipoxin A4 is measured in sputum supernatants by ELISA

Secondary Outcome Measures

Name	Time	Method
IL-33	1 day (single time point)	IL-33 is measured in sputum supernatants by ELISA
Thymic stromal lymphopoietin (TSLP)	1 day (single time point)	TSLP is measured in sputum supernatants by ELISA

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkok Noi, Bangkok, Thailand