Fixed dose combination versus free combination of tiotropium and olodaterol in COPD

• Register: EUCTR
• Last refreshed on: 13 March 2017
• Main ID: EUCTR2015-003879-29-FI
• Date of registration: 27/11/2015
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim Finland Ky
• Public title: Fixed dose combination versus free combination of tiotropium and olodaterol in COPD
• Scientific title: A 4-week, randomised, double-blind, parallel group study to evaluate the efficacy and safety of tiotropium + olodaterol fixed dose combination (5/5 µg) delivered by the Respimat® inhaler versus the free combination of tiotropium 5 µg and olodaterol 5 µg delivered by separate Respimat® inhalers in patients with chronic obstructive pulmonary disease (COPD) - Fixed dose combination versus free combination of tiotropium and olodaterol in COPD
• Date of first enrolment: 30/12/2015
• Target sample size: 350
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003879-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Austria, Denmark, Finland, France, Slovenia

Contacts

• Name: QRPE pSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim Pharma GmbH Co. & KG

• Name: QRPE pSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim Pharma GmbH Co. & KG

Key inclusion & exclusion criteria

Inclusion criteria:
- 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

Exclusion criteria:
- COPD exacerbation or symptoms of lower respiratory tract infection within 6 weeks prior to screening.
- Patients with a current diagnosis of asthma.
- Further exclusion criteria apply.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Chronic Obstructive Pulmonary Disease
MedDRA version: 19.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855

Intervention(s)

Trade Name: Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution
Product Name: Tiotropium 2.5 µg/Olodaterol 2.5µg
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: Tiotropium
CAS Number: 186691-13-4
Other descriptive name: TIOTROPIUM
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 2.5-
INN or Proposed INN: olodaterol
CAS Number: 868049-49-4
Other descriptive name: OLODATEROL
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Inhalation solution
Route of administration of the placebo: Inhalation use

Trade Name: Spiriva Respimat 2.5 microgram, inhalation solution
Product Name: Tiotropium 2.5 µg
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: Tiotropium
CAS Number: 186691-13-4
Other descriptive name: TIOTROPIUM
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 2.5-

Trade Name: Striverdi Respimat 2.5 microgram/2.5 microgram, solution for inhalation
Product Name: Olodaterol 2.5µg
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: olodaterol
CAS Number: 868049-49-4
Other descriptive name: OLODATEROL
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 2.5-

Primary Outcome(s)

Primary end point(s): 1: Trough FEV1 [L] after 28 days of treatment (measurement on Day 29)

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

Timepoint(s) of evaluation of this end point: 1: Day 29

Secondary Objective: Not applicable

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1: Day 29

2: Day 28

Secondary end point(s): 1: Trough FVC [L] after 28 days of treatment (measurement on Day 29)

2: COPD Assessment Test (CAT) score on Day 28

Secondary ID(s)

1237.49

Source(s) of Monetary Support

Boehringer Ingelheim Finland Ky