Fixed dose combination versus free combination of tiotropium and olodaterol in COPD
- Conditions
- Chronic Obstructive Pulmonary DiseaseMedDRA version: 18.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2015-003879-29-SI
- Lead Sponsor
- Boehringer Ingelheim RCV GmbH & Co KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 350
- Male or female patients.
- Patients 40 years of age or older.
- Patients with a smoking history > 10 pack years.
- Diagnostic of COPD with Post-bronchodilator FEV1 >= 30% and <80% of predicted normal and Post-bronchodilator FEV1/FVC <70% at screening.
- Symptomatic patients with CAT score >= 10 at screening.
- Further inclusion criteria apply.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110
- COPD exacerbation or symptoms of lower respiratory tract infection within 6 weeks prior to screening.
- Patients with history of asthma.
- Further exclusion criteria apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to show that the FDC of tiotropium + olodaterol (5/5 µg) is non inferior to the free combination of its monocomponents tiotropium 5 µg and olodaterol 5 µg all delivered by the Respimat® inhaler;Secondary Objective: Not applicable;Primary end point(s): 1: Trough FEV1 [L] after 28 days of treatment (measurement on Day 29)<br>;Timepoint(s) of evaluation of this end point: 1: Day 29<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1: Trough FVC [L] after 28 days of treatment (measurement on Day 29)<br><br>2: COPD Assessment Test (CAT) score on Day 28<br>;Timepoint(s) of evaluation of this end point: 1: Day 29<br><br>2: Day 28<br>