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Small Airway Obstruction in Asthma, COPD, ACOS

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ClinicalTrials.gov Identifier: NCT03423693
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Kittipong Maneechotesuwan, 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

Condition or disease Intervention/treatment
Asthma COPD Asthma-COPD Overlap Syndrome Other: No any intervention

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.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparative Study on Sputum Anti-inflammatory Mediators in Patients With Asthma or Asthma and COPD Overlap (ACOS) Syndrome, and COPD
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Choking

Group/Cohort Intervention/treatment
Asthma with SAO+
Asthmatic patients with RV/TLC > or = 40
Other: No any intervention
No any intervention is applied to any groups in this study

Asthma with SAO-
Asthmatic patients with RV/TLC < 40
Other: No any intervention
No any intervention is applied to any groups in this study

ACO
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)
Other: No any intervention
No any intervention is applied to any groups in this study

COPD
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)
Other: No any intervention
No any intervention is applied to any groups in this study




Primary Outcome Measures :
  1. Lipoxin A4, , [ Time Frame: 1 day (single time point) ]
    Lipoxin A4 is measured in sputum supernatants by ELISA


Secondary Outcome Measures :
  1. IL-33 [ Time Frame: 1 day (single time point) ]
    IL-33 is measured in sputum supernatants by ELISA

  2. Thymic stromal lymphopoietin (TSLP) [ Time Frame: 1 day (single time point) ]
    TSLP is measured in sputum supernatants by ELISA


Biospecimen Retention:   Samples With DNA
Sputum cell pellets, sputum supernatants, and sputum cytospins


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants recruited from Asthma Clinics and OPD in Siriraj Hospital
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423693


Contacts
Contact: Kittipong Maneechotesuwan, MD, PhD 6624197757 kittipong.man@mahidol.ac.th
Contact: Jirawatana Ahussawabhumi, BSc 6624197757 ext 24

Locations
Thailand
Siriraj Hospital Recruiting
Bangkok Noi, Bangkok, Thailand, 10700
Contact: Jirawatana Ahussawabhumi, BSc.         
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Kittipong Maneechotesuwan, MD, PhD Faculty of Medicine Siriraj Hospital

Responsible Party: Kittipong Maneechotesuwan, Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT03423693     History of Changes
Other Study ID Numbers: Si527/2015
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kittipong Maneechotesuwan, Mahidol University:
Small airway obstruction
Asthma
COPD
ACOS

Additional relevant MeSH terms:
Syndrome
Asthma
Airway Obstruction
Disease
Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Insufficiency
Respiration Disorders