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

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease; MedDRA version: 19.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-003879-29-FI
• Lead Sponsor: Boehringer Ingelheim Finland Ky

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-27
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified