NCT06474039

Brief Summary

This study aims to demonstrate the effects of triple therapy (ICS/LABA/LAMA) and dual bronchodilators (LAMA/LABA) on air trapping in the lungs' COPD patients and inflammatory mediators

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
4mo left

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Oct 2024Dec 2026

First Submitted

Initial submission to the registry

June 19, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

May 6, 2025

Status Verified

June 1, 2024

Enrollment Period

1.7 years

First QC Date

June 19, 2024

Last Update Submit

May 1, 2025

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

  • Changes in lung volume

    TLC, RV, RV/TLC, IOS

    4 weeks

Secondary Outcomes (1)

  • Inflammatory cytokines

    4 weeks

Study Arms (2)

Treatment 1

EXPERIMENTAL

Phase 1

Drug: Trelegy or Anoro

Treatment 2

EXPERIMENTAL

Phase 2

Drug: Trelegy or Anoro

Interventions

Trelegy or AnoroDRUG

Both drugs delivered via Ellipta device and blinded package appearance

Treatment 1Treatment 2

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have met the criteria for COPD GOLD B defined by an exacerbation not more than 1 time in the last year prior to the study enrollment. These patients will be recruited in sequential sequence.
  • Patients with COPD GOLD B are previously treated with either LAMA or LAMA/LABA or short-acting bronchodilators
  • Patients who are able to provide informed consent.

You may not qualify if:

  • \- Concomitant with active and old pulmonary TB, lung cancer, bronchiectasis, lung fibrosis, destroyed lung, other malignancy, active heart diseases.
  • Receiving long-term treatment with immunosuppressive drugs and systemic corticosteroids
  • Being treated with triple therapy (ICS/LABA/LAMA)
  • Being in terminally ill conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Respiratory Disease and TB, Siriraj Hospital

Bangkoknoi, BKK, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kittipong Maneechotesuwan, MD,PhD

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

kittipong maneechotesuwan, MD, PhD.

CONTACT

0894996858kittipong.man@mahidol.ac.th

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr.

Study Record Dates

First Submitted

June 19, 2024

First Posted

June 25, 2024

Study Start

October 1, 2024

Primary Completion

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 6, 2025

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)