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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 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.

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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.

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

FieldValue
Enrollment Target 7,903 participants
Start Date 2015-01-13
Est. Completion 2017-03-29
Phase Phase 3

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT02296138

The ClinicalTrials.gov registry entry for NCT02296138 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 7,903 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 937-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (743% higher). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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