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Optical Coherence Tomography for Assessment of the Treatment Effect of Tiotropium in Early Stage of COPD

Sponsor
Guangzhou Institute of Respiratory Disease (Other)
Overall Status
Unknown status
CT.gov ID
NCT03842839
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
31
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to explore the reversibility of airway remodeling by Endobronchial Optical Coherence Tomography (EB-OCT). In this study, EB-OCT is used to assess the treatment effect of Tiotropium in early stage of COPD. Investigators recruit COPD patients in Grade A and Grade C according to GOLD 2019. Patients in Grade A will begin to use Tiotropium once daily, and EB-OCT, pulmonary function test and chest CT will be performed in baseline, 6 months, 1 year and 2 year. Patients in Grade C will begin to use LABA+LAMA (including but not limited to Olodaterol / Tiotropium) or LAMA (Tiotropium) , same testing will be performed as patients in Grade A. Primary endpoint is airway parameters accessed by EB-OCT. And secondary end points are FEV1 and CT accessed pulmonary emphysema.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Optical Coherence Tomography for Assessment of the Treatment Effect of Tiotropium in Early Stage of COPD
Actual Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
May 1, 2021
Anticipated Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: COPD in Grade A

Patient with Grade A COPD (according to GOLD 2019), will start to use Tiotropium once daily.

Drug: Tiotropium
Tiotropium will be used once daily for 2 years.
Other Names:
  • Spiriva

    		•
    Active Comparator: COPD in Grade C

    Patient with Grade C COPD (according to GOLD 2019), will start to use Olodaterol + Tiotropium once daily.

    Drug: Tiotropium
    Tiotropium will be used once daily for 2 years.
    Other Names:
  • Spiriva

    • Drug: Olodaterol / Tiotropium
    Tiotropium or dual bronchodilators will be used, (including but not limited to Olodaterol / Tiotropium) will be used once daily for 2 years.
    Other Names:
  • Spiolto

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change of inner airway area (Ai) [Change of Ai from baseline at 2 years.]

      Change of Ai accessed by EB-OCT

    2. Change of airway wall area (Aw) [Change of Aw from baseline at 2 years.]

      Change of Aw accessed by EB-OCT

    3. Change of airway wall area percentage (Aw%) [Change of Aw% from baseline at 2 years.]

      Change of Aw% accessed by EB-OCT

    Secondary Outcome Measures

    1. Change of forced expiratory volume in 1 second (FEV1) [Change of FEV1 from baseline at 2 years.]

      Change of FEV1

    2. Change of forced vital capacity (FVC) [Change of FEV1 from baseline at 2 years.]

      Change of FVC

    3. Change of pulmonary emphysema index [Change of emphysema index from baseline at 2 years.]

      Change of emphysema index accessed by computed tomography

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients diagnosed with COPD, and be labelled Grade A and C according to "ABCD" assessment tool of the 2019 GOLD.
    Exclusion Criteria:

    • Patients with other lung diseases (such as bronchiectasis, pneumothorax, pleural effusion, airway deformation, lung surgery, etc.).

    • Patients have poor compliance and are unwilling to receive medication regularly.

    • Other complications of bronchoscopy or intolerance of bronchoscopy procedure.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong China 510120

    Sponsors and Collaborators

    • Guangzhou Institute of Respiratory Disease

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ShiYue Li, Professor, Guangzhou Institute of Respiratory Disease
    ClinicalTrials.gov Identifier:
    NCT03842839
    Other Study ID Numbers:
    • ESCOPD-20181001
    First Posted:
    Feb 15, 2019
    Last Update Posted:
    Feb 15, 2019
    Last Verified:
    Feb 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Airway Remodeling
    Tiotropium Bromide
    Olodaterol

    Study Results

    No Results Posted as of Feb 15, 2019