Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02296138 · ClinicalTrials.gov registry record · Phase 3
Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease.
A Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 7,903
- Enrollment target
- 20
- Study locations
NCT02296138: Completed Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim.
NCT02296138 is a Phase 3 study of Pulmonary Disease, Chronic Obstructive that has completed, run by Boehringer Ingelheim. The registered enrollment target is 7,903 participants, above the 937-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (743% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02296138, a Phase 3 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 7,903 participants
- Enrollment target
- 20
- Study locations
Study Summary
The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.
Primary Outcome
Annualised rate of moderate to severe COPD exacerbations during the actual treatment period was calculated per treatment per patient-year. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. Least Squares Means are actually exponentiated.
Conditions Studied
Interventions
- DRUG tiotropium
- DRUG olodaterol
Study Locations (20)
Florida
- 1237.19.10029 Boehringer Ingelheim Investigational Site - Clearwater
- 1237.19.10106 Boehringer Ingelheim Investigational Site - Clearwater
- 1237.19.10020 Boehringer Ingelheim Investigational Site - Orlando
- 1237.19.10000 Boehringer Ingelheim Investigational Site - St. Petersburg
- 1237.19.10135 Boehringer Ingelheim Investigational Site - St. Petersburg
- 1237.19.10145 Boehringer Ingelheim Investigational Site - Tamarac
- 1237.19.10066 Boehringer Ingelheim Investigational Site - Tampa
Alabama
- 1237.19.10039 Boehringer Ingelheim Investigational Site - Andalusia
- 1237.19.10009 Boehringer Ingelheim Investigational Site - Birmingham
- 1237.19.10077 Boehringer Ingelheim Investigational Site - Florence
- 1237.19.10115 Boehringer Ingelheim Investigational Site - Jasper
California
- 1237.19.10110 Boehringer Ingelheim Investigational Site - Lincoln
- 1237.19.10118 Boehringer Ingelheim Investigational Site - Los Angeles
- 1237.19.10074 Boehringer Ingelheim Investigational Site - Poway
Arizona
- 1237.19.10069 Boehringer Ingelheim Investigational Site - Flagstaff
- 1237.19.10085 Boehringer Ingelheim Investigational Site - Peoria
Colorado
- 1237.19.10157 Boehringer Ingelheim Investigational Site - Lafayette
- 1237.19.10142 Boehringer Ingelheim Investigational Site - Wheat Ridge
Connecticut
- 1237.19.10133 Boehringer Ingelheim Investigational Site - Norwalk
- 1237.19.10093 Boehringer Ingelheim Investigational Site - Stamford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7,903 participants |
| Start Date | 2015-01-13 |
| Est. Completion | 2017-03-29 |
| Phase | Phase 3 |
What the finished NCT02296138 record still lists
NCT02296138 is an interventional study that assigns participants to a tested intervention. Its 7,903 participants enrollment target places it among the larger protocols in the corpus, above the 937-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (743% higher).
The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 2 interventions - of which tiotropium is the first listed.
NCT02296138 names 20 study sites across 6 states, led by Florida, Alabama, California.
Frequently Asked Questions
What is clinical trial NCT02296138 about?
NCT02296138 is a clinical study titled "Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease.". The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.
What is the current status of trial NCT02296138?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 7,903 participants. The study started on 2015-01-13. Estimated completion is 2017-03-29.
What conditions does trial NCT02296138 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.
What interventions are being tested in trial NCT02296138?
The interventions under investigation include: tiotropium (DRUG), olodaterol (DRUG).
Who is sponsoring clinical trial NCT02296138?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02296138 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pulmonary Disease, Chronic Obstructive
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02296138's enrollment target sits among peer trials
7,903 3rd of 74 higher than 72 of 74 other Pulmonary Disease, Chronic Obstructive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Disease, Chronic Obstructive trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2)
RECRUITING · Phase 3
-
eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation
RECRUITING · Phase 3
-
Trial to Determine Effective Aspirin Dose in COPD
RECRUITING · Phase 3
-
Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)
RECRUITING · Phase 3
-
An Exercise Endurance Study to Evaluate the Effects of Treatment of Chronic Obstructive Pulmonary Disease (COPD) Patients With a Dual Bronchodilator: GSK573719/GW642444.Study B
COMPLETED · Phase 3
-
A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium Compared With Tiotropium in Subjects With Chronic Obstructive Pulmonary Disease
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00539162 · 8,000 participants · NA
Use of the CA 125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women
- NCT00898638 · 8,000 participants
Tissue Sample Collection From Patients With Head and Neck Cancer and From Healthy Participants
- NCT02240862 · 8,000 participants
The CREST-2 Registry
- NCT03072927 · 8,000 participants
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI