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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

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ClinicalTrials.gov Identifier: NCT03240575
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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).


Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Tiotropium Drug: Olodaterol Drug: Fluticasone propionate Drug: Salmeterol Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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]
Actual Study Start Date : August 14, 2017
Estimated Primary Completion Date : July 20, 2019
Estimated Study Completion Date : August 30, 2019


Arm Intervention/treatment
Experimental: Tiotropium + Olodaterol fixed dose combination Drug: Tiotropium
Fixed Dose Combination
Other Name: INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO

Drug: Olodaterol
Fixed Dose Combination
Other Name: INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO

Active Comparator: Fluticasone propionate + Salmeterol fixed dose combination Drug: Fluticasone propionate
Fixed Dose Combination

Drug: Salmeterol
Fixed Dose Combination




Primary Outcome Measures :
  1. Area Under the Curve from 0-24 hours response (change from baseline) in Forced Expiratory Volume in one second (FEV1 AUC) 0-24 h [L] after 12 weeks of treatment [ Time Frame: Baseline and Week 12 ]

Secondary Outcome Measures :
  1. Area Under the Curve from 0-12 hours response (change from baseline) in Forced Expiratory Volume in one second (FEV1 AUC) 0-12 h [L] after 12 weeks of treatment [ Time Frame: Baseline and Week 12 ]
  2. Trough Forced Expiratory Volume in one second (FEV1) response (change from baseline) [L] after 12 weeks treatment [ Time Frame: Baseline and Week 12 ]
  3. Peak 0-3h Forced Expiratory Volume in one second (FEV1) response (change from baseline) [L] after 12 weeks treatment [ Time Frame: Baseline and Week 12 ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240575


Contacts
Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

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Sponsors and Collaborators
Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03240575     History of Changes
Other Study ID Numbers: 1237-0063
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Fluticasone
Tiotropium Bromide
Salmeterol Xinafoate
Olodaterol
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Adrenergic beta-1 Receptor Agonists