Completed PHASE3 INTERVENTIONAL 4-arm NCT02497001

A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® (Kronos) (KRONOS)

A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® as an Active Control in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Sponsor: Pearl Therapeutics, Inc.

Conditions COPD

Interventions BFF MDI (PT009) 320/9.6 μg BGF MDI 320/14.4/9.6 μg GFF MDI (PT003) 14.4/9.6 μg Symbicort® Turbuhaler® (TBH) Inhalation Powder

Updated 12 times since 2017 Last updated: Dec 23, 2020 Started: Aug 10, 2015 Primary completion: Jan 5, 2018 Completion: Jan 5, 2018

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02497001, this PHASE3 trial focuses on COPD and remains completed. Sponsored by Pearl Therapeutics, Inc., it has been updated 12 times since 2015, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

12 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Mar 2019 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 7 earlier versions

Aug 2018 — Mar 2019 [monthly]

Completed PHASE3
Jun 2018 — Aug 2018 [monthly]

Completed PHASE3
May 2018 — Jun 2018 [monthly]

Completed PHASE3

Status: Active Not Recruiting → Completed
Apr 2018 — May 2018 [monthly]

Active Not Recruiting PHASE3
Sep 2017 — Apr 2018 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Feb 2017 — Sep 2017 [monthly]

Recruiting PHASE3
Jan 2017 — Feb 2017 [monthly]

Recruiting PHASE3

First recorded

Aug 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Pearl Therapeutics, Inc.

Data source: Pearl Therapeutics, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Abingdon, United States , Albuquerque, United States , Andalusia, United States , Anderson, United States , Anqing, China , Baotou, China , Beijing, China , Bunkyō City, Japan , Changchun, China , Changsha, China and 143 more locations