Clinical trial NCT04223843: 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
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].
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-01-10
Enrollment: 213
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)


Eligibility criteria: 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 β2-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

Primary outcomes:
measure: 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.
timeFrame: 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 outcomes:
measure: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) After 4 Weeks of Treatment
timeFrame: At baseline and at week 4.
Other outcomes:
Locations:
city: Andalusia
country: United States
facility: SEC Lung
state: Alabama
city: Jasper
country: United States
facility: Jasper Summit Research, LLC
state: Alabama
city: Brandon
country: United States
facility: Meris Clinical Research
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Kissimmee
country: United States
facility: Clinical Research Specialists LLC
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: New Orleans
country: United States
facility: Best Clinical Trials, LLC
state: Louisiana
city: North Dartmouth
country: United States
facility: Infinity Medical Research
state: Massachusetts
city: Farmington Hills
country: United States
facility: Pulmonary Rsrch Inst of SE MI
state: Michigan
city: Edina
country: United States
facility: Minnesota Lung Center and Sleep Institute
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Lung Center
state: Minnesota
city: Claremont
country: United States
facility: Valley Regional Hospital
state: New Hampshire
city: Bronx
country: United States
facility: CHEAR Center LLC
state: New York
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center
state: North Carolina
city: Cincinnati
country: United States
facility: Bernstein Clinical Rsrch Ctr
state: Ohio
city: Charleston
country: United States
facility: Lowcountry Lung and Critical Care
state: South Carolina
city: Clinton
country: United States
facility: Carolina Medical Research
state: South Carolina
city: Gaffney
country: United States
facility: VitaLink Research -Gaffney
state: South Carolina
city: Spartanburg
country: United States
facility: Vitalink Research - Spartansburg
state: South Carolina
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: Berlin
country: Germany
facility: Klinische Forschung Berlin GbR
city: Frankfurt
country: Germany
facility: IKF Pneumologie GmbH & Co. KG
city: Grosshansdorf
country: Germany
facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
city: Hamburg
country: Germany
facility: Hamburger Institut für Therapieforschung GmbH (HIT)
city: Lübeck
country: Germany
facility: KLB Gesundheitsforschung Lübeck GmbH
Study officials:
References: