Completed PHASE3 INTERVENTIONAL 2-arm NCT00877383

Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease (INTRUST2)

A Randomized, Double-blind, Controlled, Parallel-group, 12-week Study to Compare the Efficacy and Safety of the Combination of Indacaterol 150 µg Once Daily With Open Label Tiotropium 18 µg Once Daily Versus Open Label Tiotropium 18 µg Once Daily in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease

Sponsor: Novartis Pharmaceuticals

Conditions Chronic Obstructive Pulmonary Disease (COPD)

Interventions Indacaterol 150 μg Placebo to indacaterol Tiotropium 18 μg

Updated 8 times since 2017 Last updated: Aug 23, 2011 Started: Apr 30, 2009 Primary completion: Feb 28, 2010 Completion: Feb 28, 2010

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

This PHASE3 trial investigates Chronic Obstructive Pulmonary Disease (COPD) and is currently completed. Novartis Pharmaceuticals leads this study, which shows 8 recorded versions since 2009 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

8 versions recorded

Nov 2025 — Present [monthly]

Completed PHASE3
Sep 2025 — Nov 2025 [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3

▶ Show 3 earlier versions

Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Apr 2009

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Novartis Pharmaceuticals

Data source: Novartis

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

Study Locations

Abingdon, United States , Ahmedabad, India , Akron, United States , Alicante, Spain , Allentown, United States , Almelo, Netherlands , Almería, Spain , Anniston, United States , Armenia, Colombia , Bangalore, India and 153 more locations