Chronic Obstructive Pulmonary Disease MedDRA version: 21.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution
Product Name: Spiolto Respimat 2.5 microgram/2.5 microgram
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: T
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Signed and dated written informed consent in accordance with 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 COPD and must meet the following spirometric criteria: patients with a post-bronchodilator FEV1 =30% and =65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: -Patients with a significant disease other than COPD; 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, 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 COPD 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 COPD 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. ICS/LABA) in the 6 months prior to screening visit. -Patients being treated with oral corticosteroid medication due to reasons other than COPD 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study is designed to demonstrate the efficacy of inhaled tiotropium + olodaterol via Respimat® on lung function in patients with moderate to severe COPD with optimal and a sub-optimal PIFR. Disease severity (moderate to severe) is based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (GOLD 2 – 3).;Secondary Objective: NA;Primary end point(s): 1: Change from baseline in FEV1 AUC0-3h 2: Analyses will be performed in PIFR optimal (=60 L/min) group and PIFR sub-optimal (<60 L/min) group separately.;Timepoint(s) of evaluation of this end point: 1: After 4 weeks of treatment 2: After 4 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: Change from baseline in trough FEV1 2: Analyses will be performed in PIFR optimal (=60 L/min) group and PIFR sub-optimal (<60 L/min) group separately.;Timepoint(s) of evaluation of this end point: 1: After 4 weeks of treatment 2: After 4 weeks of treatment | — |
Countries
Germany, Spain, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed