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

NCT04223843 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 1237-00952019-001719-21
• Study Type: interventional
• Target: 213
• Locations: 2 countries
• Sites: 26

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)

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) After 4 Weeks of Treatment

  At baseline and at week 4.

Study Arms (2)

Active Arm

EXPERIMENTAL

Tiotropium + Olodaterol Fixed Dose Combination (FDC) via Respimat

Drug: Tiotropium + olodaterol

Placebo Arm

PLACEBO COMPARATOR

Matching placebo via Respimat

Drug: Placebo

Interventions

Tiotropium + olodaterol DRUG

Oral Inhalation

Active Arm

Placebo DRUG

Oral Inhalation

Placebo Arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (26)

SEC Lung

Andalusia, Alabama, 36420, United States

Location

Jasper Summit Research, LLC

Jasper, Alabama, 35501, United States

Location

Meris Clinical Research

Brandon, Florida, 33511, United States

Location

Clinical Research of West Florida, Inc.

Clearwater, Florida, 33765, United States

Location

Clinical Research Specialists LLC

Kissimmee, Florida, 34746, United States

Location

Clinical Research of West Florida, Inc.

Tampa, Florida, 33606, United States

Location

Best Clinical Trials, LLC

New Orleans, Louisiana, 70115, United States

Location

Infinity Medical Research

North Dartmouth, Massachusetts, 02747, United States

Location

Pulmonary Rsrch Inst of SE MI

Farmington Hills, Michigan, 48152, United States

Location

Minnesota Lung Center and Sleep Institute

Edina, Minnesota, 55435, United States

Location

Minnesota Lung Center

Woodbury, Minnesota, 55125, United States

Location

Valley Regional Hospital

Claremont, New Hampshire, 03743, United States

Location

CHEAR Center LLC

The Bronx, New York, 10455, United States

Location

North Carolina Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Southeastern Research Center

Winston-Salem, North Carolina, 27103, United States

Location

Bernstein Clinical Rsrch Ctr

Cincinnati, Ohio, 45231, United States

Location

Lowcountry Lung and Critical Care

Charleston, South Carolina, 29406, United States

Location

Carolina Medical Research

Clinton, South Carolina, 29325, United States

Location

VitaLink Research -Gaffney

Gaffney, South Carolina, 29340, United States

Location

Vitalink Research - Spartansburg

Spartanburg, South Carolina, 29303, United States

Location

Diagnostics Research Group

San Antonio, Texas, 78229, United States

Location

Klinische Forschung Berlin GbR

Berlin, 10787, Germany

Location

IKF Pneumologie GmbH & Co. KG

Frankfurt, 60596, Germany

Location

Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

Großhansdorf, 22927, Germany

Location

Hamburger Institut für Therapieforschung GmbH (HIT)

Hamburg, 20354, Germany

Location

KLB Gesundheitsforschung Lübeck GmbH

Lübeck, 23552, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

tiotropium-olodaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 10, 2020
• Study Start: January 8, 2020
• Primary Completion: September 7, 2020
• Study Completion: September 29, 2020
• Last Updated: November 18, 2021
• Results First Posted: November 18, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.

Locations

DE (5); US (21)