A Study to Test the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler in People With Chronic Obstructive Pulmonary Disease (COPD) Who Have Different Abilities to Inhale

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel Group Study to Compare the Efficacy of Inhaled Tiotropium + Olodaterol, Fixed Dose Combination (5 mcg/5mcg) vs. Placebo Delivered by Respimat Inhaler in Patients With Moderate to Severe COPD, Stratified by Peak Inspiratory Flow Rate [TRONARTO].

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04223843
• Other study ID #: 1237-0095
• Secondary ID: 2019-001719-21
• Status: Completed
• Phase: Phase 4
• Start date: January 8, 2020
• Est. completion date: September 29, 2020

Study information

• Verified date: October 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To demonstrate the efficacy of inhaled tiotropium + olodaterol via Respimat® on lung function in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) with optimal and sub-optimal Peak Inspiratory Flow Rate (PIFR). Disease severity (moderate to severe) is based on the Global Initiative for Chronic Lung Disease (GOLD) guidelines (GOLD 2 - 3)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: September 29, 2020
• Est. primary completion date: September 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Signed and dated written informed consent in accordance with International Council on Harmonisation Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
• Male or female patients, 40 years of age or older.
• All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) >30% and <80% of predicted normal (European Coal and Steel Community (ECSC), [R94-1408]); and a postbronchodilator FEV1/ Functional Residual Capacity (FVC) <70%, at the screening visit.
• Patients must be current or ex-smokers with a smoking history of more than 10 pack years
• Patients should meet the peak inspiratory flow rate criteria (optimal or sub-optimal) at the time of randomization depending on which strata is available for inclusion in the study.
• Women of childbearing potential must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
• Patients are expected to be able to perform, according to investigator's judgment, all

trial related procedures including:

• Technically acceptable pulmonary function tests (spirometry)
• Use of In-Check DIAL G16 device to measure peak inspiratory flow rate.
• Inhale medication in a competent manner (in the opinion of the investigator) from the Respimat® device
• Perform technically acceptable body plethysmography measurements. This is applicable only to patients who will consent to the optional trial procedure at the selected sites.

Exclusion Criteria:

• Patients with a significant disease other than chronic obstructive pulmonary disease; a significant disease defined as a disease which, in the opinion of the investigator, and referring to the warnings to be observed as quoted in the locally applicable SmPC or prescribing information, could (i) put the patient at risk because of participation in the trial, (ii) influence the results of the trial, or (iii) cause concern regarding the patient's ability to participate in the trial.
• Patients who have had a chronic obstructive pulmonary disease exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 6 weeks prior to screening visit or during the screening period.
• Patients who experienced two or more moderate chronic obstructive pulmonary disease exacerbations (exacerbation that required treatment with antibiotics and/or oral corticosteroids), or one or more exacerbation leading to hospitalization within a year prior to visit 1.
• 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.
• Patients taking inhaled corticosteroids (including combinations, e.g. inhaled corticosteroids / Long-Acting ß2-agonist) in the 6 months prior to screening visit.
• Patients being treated with oral corticosteroid medication due to reasons other than chronic obstructive pulmonary disease exacerbation within 6 weeks prior to the screening visit.
• Patients who have completed a pulmonary rehabilitation program in the 6 weeks prior to screening visit or patients who are currently in a pulmonary rehabilitation program.
• Further criteria apply

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium + olodaterol
Oral Inhalation
• Placebo
Oral Inhalation

Locations

Country	Name	City	State
Germany	Klinische Forschung Berlin GbR	Berlin
Germany	IKF Pneumologie GmbH & Co. KG	Frankfurt
Germany	Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH	Grosshansdorf
Germany	Hamburger Institut für Therapieforschung GmbH (HIT)	Hamburg
Germany	KLB Gesundheitsforschung Lübeck GmbH	Lübeck
United States	SEC Lung	Andalusia	Alabama
United States	Meris Clinical Research	Brandon	Florida
United States	CHEAR Center LLC	Bronx	New York
United States	Lowcountry Lung and Critical Care	Charleston	South Carolina
United States	Bernstein Clinical Rsrch Ctr	Cincinnati	Ohio
United States	Valley Regional Hospital	Claremont	New Hampshire
United States	Clinical Research of West Florida, Inc.	Clearwater	Florida
United States	Carolina Medical Research	Clinton	South Carolina
United States	Minnesota Lung Center and Sleep Institute	Edina	Minnesota
United States	Pulmonary Rsrch Inst of SE MI	Farmington Hills	Michigan
United States	VitaLink Research -Gaffney	Gaffney	South Carolina
United States	Jasper Summit Research, LLC	Jasper	Alabama
United States	Clinical Research Specialists LLC	Kissimmee	Florida
United States	Best Clinical Trials, LLC	New Orleans	Louisiana
United States	Infinity Medical Research	North Dartmouth	Massachusetts
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	Diagnostics Research Group	San Antonio	Texas
United States	Vitalink Research - Spartansburg	Spartanburg	South Carolina
United States	Clinical Research of West Florida, Inc.	Tampa	Florida
United States	Southeastern Research Center	Winston-Salem	North Carolina
United States	Minnesota Lung Center	Woodbury	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) After 4 Weeks of Treatment.	FEV1 AUC0-3h was calculated as the area under the FEV1-time curve from 0 to 3h post-dose using the trapezoidal rule, divided by the duration (3h) to report in liters. Mean is adjusted mean.; A hierarchical testing procedure was used to test the primary endpoint. Each of the tests were considered confirmatory only if all previous tests were successful.	At baseline and at week 4: 10 minutes (min) prior and 5 min, 15 min, 30 min and 1 hour (h), 2h and 3h after drug administration, respectively.
Secondary	Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) After 4 Weeks of Treatment	Change from baseline in trough Forced Expiratory Volume in one second (FEV1) after 4 weeks of treatment.	At baseline and at week 4.

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