The ENERGITO® 2 Study Compares 2 Inhaled Medicines for Chronic Obstructive Pulmonary Disease (COPD). One Medicine is a Combination of Tiotropium and Olodaterol (Stiolto®) Taken Using the Respimat® Inhaler and the Other Medicine is a Combination of Fluticasone and Salmeterol Taken Using the Diskus
Public ClinicalTrials.gov record NCT03240575. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Double-dummy, Active-controlled, Multi-center, Parallel Group Study to Show the Superiority in Lung Function of 12 Weeks Once Daily Treatment With Orally Inhaled Tiotropium+Olodaterol Fixed Dose Combination Delivered by the Respimat® Inhaler vs. 12 Weeks Twice Daily Treatment With Fluticasone Propionate+Salmeterol Fixed Dose Combination Delivered by the Diskus® in Patients With Chronic Obstructive Pulmonary Disease (COPD) [ENERGITO® 2]
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of the trial is to show superiority in lung function of once daily (2 inhalations) treatment with orally inhaled tiotropium+olodaterol fixed dose combination to twice daily (one inhalation) treatment with fluticasone propionate+salmeterol fixed dose combination over 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). A Digital Health (DH) exploratory study has been integrated into the main study as a site specific study. The DH exploratory study will be performed at a single site; the site is also participating in the main study. The DH exploratory study site will enter (randomize) approximately 20 patients (subjects) (in addition to the patients to be enrolled in the main study at this site). The patients enrolled in the DH exploratory study are not considered to be part of the main study (i.e. data collected in the DH exploratory study will be analyzed separately from the data collected in the main study).
Study identification
- NCT ID
- NCT03240575
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 302 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 14, 2017 (Actual)
- Primary completion
- Apr 8, 2019 (Actual)
- Completion
- May 6, 2019 (Actual)
- Last update posted
- Apr 16, 2020
2017 – 2019
United States locations
- U.S. sites
- 45
- U.S. states
- 21
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Jasper Summit Research, LLC | Jasper | Alabama | 35501 | — |
| Clinical Trial Connection | Flagstaff | Arizona | 86001 | — |
| California Research Medical Group, Inc. | Fullerton | California | 92835 | — |
| Allergy and Asthma Specialists Medical Group | Huntington Beach | California | 92647 | — |
| California Medical Research Associates Inc. | Northridge | California | 91324 | — |
| IMMUNOe Research Centers | Centennial | Colorado | 80112 | — |
| Clinical Research of West Florida, Inc. | Clearwater | Florida | 33765 | — |
| Bioclinica Research | Orlando | Florida | 32806 | — |
| IMIC, Inc | Palmetto Bay | Florida | 33157 | — |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 33603 | — |
| Duluth Biomedical Research | Duluth | Georgia | 30096 | — |
| DC Pulmonary Medicine | Marietta | Georgia | 30060 | — |
| New Orleans Center for Clinical Research | New Orleans | Louisiana | 70119 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21224 | — |
| Pulmonary Rsrch Inst of SE MI | Farmington Hills | Michigan | 48336 | — |
| Minnesota Lung Center and Sleep Institute | Edina | Minnesota | 55435 | — |
| Clinical Research Institute Inc | Minneapolis | Minnesota | 55402 | — |
| Minnesota Lung Center | Woodbury | Minnesota | 55125 | — |
| The Clinical Research Center, LLC | St Louis | Missouri | 63141 | — |
| Northwell Health | New Hyde Park | New York | 11040 | — |
| Gastonia Pharmaceutical Research, LLC | Gastonia | North Carolina | 28054 | — |
| Hendersonville Pharmaceutical Research | Hendersonville | North Carolina | 28739 | — |
| North Carolina Clinical Research | Raleigh | North Carolina | 27607 | — |
| Southeastern Research Center | Winston-Salem | North Carolina | 27103 | — |
| Bernstein Clinical Rsrch Ctr | Cincinnati | Ohio | 45231 | — |
| Aventiv Research Inc. | Columbus | Ohio | 43213 | — |
| Aventiv Research Inc. | Dublin | Ohio | 43016 | — |
| OK Clinical Research, LLC | Edmond | Oklahoma | 73034 | — |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | — |
| Arcuri Clinical Research, LLC | Philadelphia | Pennsylvania | 19142 | — |
| Lowcountry Lung and Critical Care | Charleston | South Carolina | 29406 | — |
| VitaLink Research - Easley | Easley | South Carolina | 29640 | — |
| VitaLink Research -Gaffney | Gaffney | South Carolina | 29340 | — |
| VitaLink Research | Greenville | South Carolina | 29615 | — |
| Vita Link Research- Rock Hill | Rock Hill | South Carolina | 29732 | — |
| South Carolina Pharma Rsrch | Spartanburg | South Carolina | 29303 | — |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | — |
| Centex Studies, Inc. | Houston | Texas | 77058 | — |
| Advanced Clinical Research Associates | Plano | Texas | 75093 | — |
| Sherman Clinical Research | Sherman | Texas | 75092 | — |
| DM Clinical Research | Tomball | Texas | 77375 | — |
| Pulmonary Associates of Richmond, Inc. | Richmond | Virginia | 23225 | — |
| Pulmonary Associates of Richmond, Inc. | Richmond | Virginia | 23229 | — |
| MultiCare Institute for Research and Innovation | Tacoma | Washington | 98405 | — |
| Morgantown Pulmonary ClinRsrch | Morgantown | West Virginia | 26505 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03240575, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 16, 2020 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03240575 live on ClinicalTrials.gov.