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

NCT ID: NCT03240575

Last Updated: 2020-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 302 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-14
• Study Completion Date: 2019-05-06

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).

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tiotropium + Olodaterol fixed dose combination

Group Type: EXPERIMENTAL

Tiotropium

Intervention Type: DRUG

Fixed Dose Combination

Olodaterol

Intervention Type: DRUG

Fixed Dose Combination

Fluticasone propionate + Salmeterol fixed dose combination

Group Type: ACTIVE_COMPARATOR

Fluticasone propionate

Intervention Type: DRUG

Fixed Dose Combination

Salmeterol

Intervention Type: DRUG

Fixed Dose Combination

Interventions

Tiotropium

Fixed Dose Combination

Intervention Type: DRUG

Olodaterol

Fixed Dose Combination

Intervention Type: DRUG

Fluticasone propionate

Fixed Dose Combination

Intervention Type: DRUG

Salmeterol

Fixed Dose Combination

Intervention Type: DRUG

Other Intervention Names

INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO; INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.
• Patients who have undergone thoracotomy with pulmonary resection (patients with a history of thoracotomy for other reasons should be evaluated as per the first exclusion criterion).
• Patients being treated with oral or patch β-adrenergics.
• Patients being treated with oral corticosteroid medication within 6 weeks prior to Visit 1.
• Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits.
• Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program.
• Patients who have taken an investigational drug within one month, six half-lives or within the wash out period (whichever is greater) prior to screening visit (Visit 1).
• Patients with known hypersensitivity to β-adrenergic drugs, BAC, EDTA, or any other component of the Respimat® inhalation solution. In addition, patients with known hypersensitivity to Lactose monohydrate (which contains milk proteins).
• Pregnant or nursing women.
• Women of childbearing potential not using a method of birth control classified at least as "acceptable". Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or post-menopausal (defined as no menses for 12 months without an alternative medical cause). Tubal ligation is NOT a method of permanent sterilisation.
• Patients who have previously been randomized in this study or are currently participating in another study.
• Patients who are unable to comply with pulmonary medication restrictions prior to randomization.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jasper Summit Research, LLC

Jasper, Alabama, United States

Clinical Trial Connection

Flagstaff, Arizona, United States

California Research Medical Group, Inc.

Fullerton, California, United States

Allergy and Asthma Specialists Medical Group

Huntington Beach, California, United States

California Medical Research Associates Inc.

Northridge, California, United States

IMMUNOe Research Centers

Centennial, Colorado, United States

Clinical Research of West Florida, Inc.

Clearwater, Florida, United States

Bioclinica Research

Orlando, Florida, United States

IMIC, Inc

Palmetto Bay, Florida, United States

Clinical Research of West Florida, Inc.

Tampa, Florida, United States

Duluth Biomedical Research

Duluth, Georgia, United States

DC Pulmonary Medicine

Marietta, Georgia, United States

New Orleans Center for Clinical Research

New Orleans, Louisiana, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Pulmonary Rsrch Inst of SE MI

Farmington Hills, Michigan, United States

Minnesota Lung Center and Sleep Institute

Edina, Minnesota, United States

Clinical Research Institute Inc

Minneapolis, Minnesota, United States

Minnesota Lung Center

Woodbury, Minnesota, United States

The Clinical Research Center, LLC

St Louis, Missouri, United States

Northwell Health

New Hyde Park, New York, United States

Gastonia Pharmaceutical Research, LLC

Gastonia, North Carolina, United States

Hendersonville Pharmaceutical Research

Hendersonville, North Carolina, United States

North Carolina Clinical Research

Raleigh, North Carolina, United States

Southeastern Research Center

Winston-Salem, North Carolina, United States

Bernstein Clinical Rsrch Ctr

Cincinnati, Ohio, United States

Aventiv Research Inc.

Columbus, Ohio, United States

Aventiv Research Inc.

Dublin, Ohio, United States

OK Clinical Research, LLC

Edmond, Oklahoma, United States

IPS Research Company

Oklahoma City, Oklahoma, United States

Arcuri Clinical Research, LLC

Philadelphia, Pennsylvania, United States

Lowcountry Lung and Critical Care

Charleston, South Carolina, United States

VitaLink Research - Easley

Easley, South Carolina, United States

VitaLink Research -Gaffney

Gaffney, South Carolina, United States

VitaLink Research

Greenville, South Carolina, United States

Vita Link Research- Rock Hill

Rock Hill, South Carolina, United States

South Carolina Pharma Rsrch

Spartanburg, South Carolina, United States

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Centex Studies, Inc.

Houston, Texas, United States

Advanced Clinical Research Associates

Plano, Texas, United States

Sherman Clinical Research

Sherman, Texas, United States

DM Clinical Research

Tomball, Texas, United States

Pulmonary Associates of Richmond, Inc.

Richmond, Virginia, United States

Pulmonary Associates of Richmond, Inc.

Richmond, Virginia, United States

MultiCare Institute for Research and Innovation

Tacoma, Washington, United States

Morgantown Pulmonary ClinRsrch

Morgantown, West Virginia, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

1237-0063

Identifier Type: -

Identifier Source: org_study_id