Pulmonary Disease, Chronic ObstructivePhase 4NCT03240575

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 Phase 4 study testing Tiotropium, Olodaterol and Fluticasone propionate in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 45 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Tiotropium, Olodaterol and Fluticasone propionate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 302 participants
Where: 45 sitesUnited States
Study dates: 14 Aug 2017to 6 May 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

Show all 9Show fewer

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).

Who cannot join

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).

Show all 26Show fewer

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.

Trial locations and contacts

45 sites in 1 country.

City, postcode or hospital

45 sites in 1 country

United States45 sites

Johns Hopkins Hospital
Baltimore, Maryland, 21224
IMMUNOe Research Centers
Centennial, Colorado, 80112
Lowcountry Lung and Critical Care
Charleston, South Carolina, 29406
Bernstein Clinical Rsrch Ctr
Cincinnati, Ohio, 45231
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
Aventiv Research Inc.
Columbus, Ohio, 43213
Aventiv Research Inc.
Dublin, Ohio, 43016
Duluth Biomedical Research
Duluth, Georgia, 30096
VitaLink Research - Easley
Easley, South Carolina, 29640
Minnesota Lung Center and Sleep Institute
Edina, Minnesota, 55435
OK Clinical Research, LLC
Edmond, Oklahoma, 73034
Pulmonary Rsrch Inst of SE MI
Farmington Hills, Michigan, 48336
Clinical Trial Connection
Flagstaff, Arizona, 86001
California Research Medical Group, Inc.
Fullerton, California, 92835
VitaLink Research -Gaffney
Gaffney, South Carolina, 29340
Gastonia Pharmaceutical Research, LLC
Gastonia, North Carolina, 28054
VitaLink Research
Greenville, South Carolina, 29615
Hendersonville Pharmaceutical Research
Hendersonville, North Carolina, 28739
Centex Studies, Inc.
Houston, Texas, 77058
Allergy and Asthma Specialists Medical Group
Huntington Beach, California, 92647
Jasper Summit Research, LLC
Jasper, Alabama, 35501
DC Pulmonary Medicine
Marietta, Georgia, 30060
Clinical Research Institute Inc
Minneapolis, Minnesota, 55402
Morgantown Pulmonary ClinRsrch
Morgantown, West Virginia, 26505
Northwell Health
New Hyde Park, New York, 11040
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119
California Medical Research Associates Inc.
Northridge, California, 91324
IPS Research Company
Oklahoma City, Oklahoma, 73103
Bioclinica Research
Orlando, Florida, 32806
IMIC, Inc
Palmetto Bay, Florida, 33157
Arcuri Clinical Research, LLC
Philadelphia, Pennsylvania, 19142
Advanced Clinical Research Associates
Plano, Texas, 75093
North Carolina Clinical Research
Raleigh, North Carolina, 27607
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23225
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23229
Vita Link Research- Rock Hill
Rock Hill, South Carolina, 29732
Sherman Clinical Research
Sherman, Texas, 75092
South Carolina Pharma Rsrch
Spartanburg, South Carolina, 29303
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
The Clinical Research Center, LLC
St Louis, Missouri, 63141
MultiCare Institute for Research and Innovation
Tacoma, Washington, 98405
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603
DM Clinical Research
Tomball, Texas, 77375
Southeastern Research Center
Winston-Salem, North Carolina, 27103
Minnesota Lung Center
Woodbury, Minnesota, 55125

Other trials in United States

About this study

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]

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
Being tested: Tiotropium, Olodaterol, Fluticasone propionate, Salmeterol
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TiotropiumDrug
Also called INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO
Fixed Dose Combination
OlodaterolDrug
Also called INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO
Fixed Dose Combination
Fluticasone propionateDrug
Fixed Dose Combination
SalmeterolDrug
Fixed Dose Combination

Study groups in NCT03240575
Study group	Role	What they receive
Tiotropium + Olodaterol fixed dose combination	Experimental	Not described Receives: Drug: Tiotropium; Drug: Olodaterol
Fluticasone propionate + Salmeterol fixed dose combination	Active comparator	Not described Receives: Drug: Fluticasone propionate; Drug: Salmeterol

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
FEV1 AUC0-12 was calculated as the area under the FEV1-time curve from 0-12 hours post-dose using the trapezoidal rule, divided by the duration (12 hours) and reported in liters. FEV1 AUC0-12 response (change from baseline) was defined as FEV1 AUC0-12 minus baseline FEV1.
Measured: 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
Trough Forced Expiratory Volume in one second (FEV1) response (change from baseline) [L] after 12 weeks treatment. Trough FEV1 was defined as the mean of the FEV1 value measured at 23 hours and at 24 hours after the trial medication administration. Through FEV1 response (change from baseline) was defined as trough FEV1 minus baseline FEV1.
Measured: 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
Peak 0-3 hours Forced Expiratory Volume in one second (FEV1) response (change from baseline) [L] after 12 weeks treatment. Peak 0-3h was defined as the maximum value measured within the first three hours post doing.
Measured: 30 minutes, 1 h, 2h and 3h post dose at baseline and week 12.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Aug 20176 May 2019

First posted7 Aug 2017
Study start14 Aug 2017
Primary completion8 Apr 2019
Study completion6 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 302 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03240575
Sponsor's protocol ID: 1237-0063
Status last verified: Apr 2020
First submitted: 27 Jul 2017
Last updated: 16 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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]
ClinicalTrials.gov ID: NCT03240575
Acronym / sponsor ID: 1237-0063
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 302 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 14 Aug 2017 (actual)
Primary completion: 8 Apr 2019 (actual)
Study completion: 6 May 2019 (actual)
First posted: 7 Aug 2017 (actual)
Results: Posted 16 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Tiotropium + Olodaterol fixed dose combination	Experimental	Drug: Tiotropium, Drug: Olodaterol
Fluticasone propionate + Salmeterol fixed dose combination	Active comparator	Drug: Fluticasone propionate, Drug: Salmeterol

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (26 listed)

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.
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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TiotropiumAlso: INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMOFixed Dose Combination	Drug	Tiotropium + Olodaterol fixed dose combination
OlodaterolAlso: INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMOFixed Dose Combination	Drug	Tiotropium + Olodaterol fixed dose combination
Fluticasone propionateFixed Dose Combination	Drug	Fluticasone propionate + Salmeterol fixed dose combination
SalmeterolFixed Dose Combination	Drug	Fluticasone propionate + Salmeterol fixed dose combination

Primary outcome

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
Time frame: 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.
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.

3 secondary outcomes

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
Time frame: 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
Time frame: 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
Time frame: 30 minutes, 1 h, 2h and 3h post dose at baseline and week 12.

Results and safety

Results posted to the registry on 16 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tiotropium+Olodaterol (5μg/5μg) - Main Study	146	144
Fluticasone Propionate+Salmeterol (500μg/100μg) - Main Study	145	131
Tiotropium+Olodaterol (5μg/5μg) - DH-study	6	6
Fluticasone Propionate+Salmeterol (500μg/100μg) - DH-study	5	3

Primary outcome: 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

Time frame: 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.. Mean (Standard Error). Unit: Litre*hours (L*h)

Measure	Tiotropium+Olodaterol (5μg/5μg) - Main Study n = 145	Fluticasone Propionate+Salmeterol (500μg/100μg) - Main Study n = 138	Tiotropium+Olodaterol (5μg/5μg) - DH-study n = 6	Fluticasone Propionate+Salmeterol (500μg/100μg) - DH-study n = 4
Value	0.174 (0.019)	0.122 (0.019)	NA (NA)	NA (NA)

Tiotropium+Olodaterol (5μg/5μg) - Main Study vs Fluticasone Propionate+Salmeterol (500μg/100μg) - Main Study: Mean Difference (Net): 0.052 (95% CI -0.001 to 0.105), p = 0.0543, Mixed-effects model repeated measures

Population analysed: Full Analysis Set (FAS): FAS included all patients in the TS who had baseline and at least one post-baseline measurement for at least one efficacy parameter. The Mixed-effects model repeated measurement (MMRM) model defined the participants who contributed to the model.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From screening visit (28 days before treatment start) until end of follow up period (up to 105 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tiotropium+Olodaterol (5μg/5μg)	6 of 152 (3.9%)	8 of 152 (5.3%)	0 of 152
Fluticasone Propionate+Salmeterol (500μg/100μg)	3 of 150 (2%)	15 of 150 (10%)	0 of 150

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Pulmonary Disease, Chronic Obstructive

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

45 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tiotropium, Olodaterol and Fluticasone propionate in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 45 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03240575.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2020; AzTrials last refreshed its copy on 1 Nov 2026.