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
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]
1 other identifier
interventional
302
1 country
45
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2017
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2017
CompletedFirst Posted
Study publicly available on registry
August 7, 2017
CompletedStudy Start
First participant enrolled
August 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 6, 2019
CompletedResults Posted
Study results publicly available
April 16, 2020
CompletedApril 16, 2020
April 1, 2020
1.6 years
July 27, 2017
April 3, 2020
April 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 24 Hours (AUC0-24) Response (Change From Baseline) [L] After 12 Weeks of Treatment
Forced Expiratory Volume in one second (FEV1) Area under the Curve from 0 to 24 hours (AUC0-24) response (change from baseline) \[L\] after 12 weeks of treatment. FEV1 AUC0-24 was calculated as the area under the FEV1-time curve from 0-24 hours post-dose using the trapezoidal rule, divided by the duration (24 hours) and reported in liters. FEV1 AUC0-24 response (change from baseline) was defined as FEV1 AUC0-24 mius baseline FEV1.
1 hours (h) and 10 minutes (min) before first dose at day1 of weeks 1 for baseline.10 min before and 30 min, 1 h, 2h, 3h, 4h, 6h, 8h, 10h, 11h 50min, 12h 30 min, 13h, 14h, 22h, 23h, and 24h post morning dose at week 12.
Secondary Outcomes (3)
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 12 Hours (AUC0-12) Response (Change From Baseline) [L] After 12 Weeks of Treatment
1 hours (h) and 10 minutes (min) before first dose at day1 of weeks 1 for baseline. 10 min before and 30 min, 1 h, 2h, 3h, 4h, 6h, 8h, 10h, 11h 50min post morning dose at week 12.
Trough Forced Expiratory Volume in One Second (FEV1) Response (Change From Baseline) [L] After 12 Weeks Treatment
At 23 h and 24 h post dose at baseline and at 23h and 24 h post dose at week 12.
Peak 0-3 Hours Forced Expiratory Volume in One Second (FEV1) Response (Change From Baseline) [L] After 12 Weeks Treatment
30 minutes, 1 h, 2h and 3h post dose at baseline and week 12.
Study Arms (2)
Tiotropium + Olodaterol fixed dose combination
EXPERIMENTALFluticasone propionate + Salmeterol fixed dose combination
ACTIVE COMPARATORInterventions
Fixed Dose Combination
Fixed Dose Combination
Fixed Dose Combination
Eligibility Criteria
You may qualify if:
- All patients must sign an informed consent consistent with FDA regulations prior to participation in the trial, which includes medication washout and restrictions.
- All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
- \-- Patients with a post-bronchodilator 30% ≤ Forced Expiratory Volume in one second (FEV1) \<80% of predicted normal (European Coal and Steel Community( ECSC)); and a post-bronchodilator FEV1/Forced Vital Capacity (FVC) \<70% at Visit 1
- Male or female patients, 40 years of age or older.
- Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded.
- Patients must be able to perform, according to investigator's judgment, all trial related procedures including:
- Technically acceptable pulmonary function tests (spirometry)
- Completion of study questionnaires
- Patients must be able to inhale medication in a competent manner (in the opinion of the investigator) from the Respimat® and Diskus® inhalers and from a metered dose inhaler (MDI).
You may not qualify if:
- Patients with a significant disease other than Chronic Obstructive Pulmonary Disease (COPD); a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study.
- Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the last 3 months prior to Visit 1 and/or between Visit 1 and Visit 2.
- Patients with a history of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma. If a patient has a total blood eosinophil count ≥ 600/mm3, source documentation is required to verify that the increased eosinophil count is related to a nonasthmatic condition.
- Patients with any of the following conditions:
- A diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists).
- A diagnosis of paroxysmal tachycardia (\>100 beats per minute) (due to the known class side effect profile of ß2-agonists).
- A history of myocardial infarction within 1 year of screening visit (Visit 1).
- Unstable or life-threatening cardiac arrhythmia.
- Hospitalization for heart failure within the past year.
- Known active tuberculosis.
- A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed).
- A history of life-threatening pulmonary obstruction.
- A history of cystic fibrosis.
- Clinically evident bronchiectasis.
- A history of significant alcohol or drug abuse.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Jasper Summit Research, LLC
Jasper, Alabama, 35501, United States
Clinical Trial Connection
Flagstaff, Arizona, 86001, United States
California Research Medical Group, Inc.
Fullerton, California, 92835, United States
Allergy and Asthma Specialists Medical Group
Huntington Beach, California, 92647, United States
California Medical Research Associates Inc.
Northridge, California, 91324, United States
IMMUNOe Research Centers
Centennial, Colorado, 80112, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765, United States
Bioclinica Research
Orlando, Florida, 32806, United States
IMIC, Inc
Palmetto Bay, Florida, 33157, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603, United States
Duluth Biomedical Research
Duluth, Georgia, 30096, United States
DC Pulmonary Medicine
Marietta, Georgia, 30060, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21224, United States
Pulmonary Rsrch Inst of SE MI
Farmington Hills, Michigan, 48336, United States
Minnesota Lung Center and Sleep Institute
Edina, Minnesota, 55435, United States
Clinical Research Institute Inc
Minneapolis, Minnesota, 55402, United States
Minnesota Lung Center
Woodbury, Minnesota, 55125, United States
The Clinical Research Center, LLC
St Louis, Missouri, 63141, United States
Northwell Health
New Hyde Park, New York, 11040, United States
Gastonia Pharmaceutical Research, LLC
Gastonia, North Carolina, 28054, United States
Hendersonville Pharmaceutical Research
Hendersonville, North Carolina, 28739, United States
North Carolina Clinical Research
Raleigh, North Carolina, 27607, United States
Southeastern Research Center
Winston-Salem, North Carolina, 27103, United States
Bernstein Clinical Rsrch Ctr
Cincinnati, Ohio, 45231, United States
Aventiv Research Inc.
Columbus, Ohio, 43213, United States
Aventiv Research Inc.
Dublin, Ohio, 43016, United States
OK Clinical Research, LLC
Edmond, Oklahoma, 73034, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Arcuri Clinical Research, LLC
Philadelphia, Pennsylvania, 19142, United States
Lowcountry Lung and Critical Care
Charleston, South Carolina, 29406, United States
VitaLink Research - Easley
Easley, South Carolina, 29640, United States
VitaLink Research -Gaffney
Gaffney, South Carolina, 29340, United States
VitaLink Research
Greenville, South Carolina, 29615, United States
Vita Link Research- Rock Hill
Rock Hill, South Carolina, 29732, United States
South Carolina Pharma Rsrch
Spartanburg, South Carolina, 29303, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
Centex Studies, Inc.
Houston, Texas, 77058, United States
Advanced Clinical Research Associates
Plano, Texas, 75093, United States
Sherman Clinical Research
Sherman, Texas, 75092, United States
DM Clinical Research
Tomball, Texas, 77375, United States
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23225, United States
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23229, United States
MultiCare Institute for Research and Innovation
Tacoma, Washington, 98405, United States
Morgantown Pulmonary ClinRsrch
Morgantown, West Virginia, 26505, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The objectives of the DH-study were exploratory. The DH-study aimed to gather information and experience about the feasibility of a remote trial in this indication, and was not designed to support treatment comparisons.
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2017
First Posted
August 7, 2017
Study Start
August 14, 2017
Primary Completion
April 8, 2019
Study Completion
May 6, 2019
Last Updated
April 16, 2020
Results First Posted
April 16, 2020
Record last verified: 2020-04