Study to assess the efficacy and safety of tiotropium+olodaterol fixed dose combination in patients with COPD

• Conditions: Patients with Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 16.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2009-010668-40-DK
• Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-30
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
2. All patients must have a diagnosis of chronic obstructive pulmonary diseaseand must meet the following spirometric criteria:
Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1< 80% of predicted normal and a post-bronchodilator FEV1/FVC <70% at Visit 1
3. Male or female patients, 40 years of age or older.
4.Patients must be current or ex-smokers with a smoking history of more than 10 pack years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients with a significant disease other than COPD;
2.Patients with a, in the opinion of the investigator, clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis;
3.Patients with a history of asthma.
Patients with any of the following conditions:
4.A diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists).
5.A diagnosis of (>100 beats per minute) (due to the known class side effect profile of ß2-agonists).
6.A history of myocardial infarction within 1 year of screening visit (Visit 1).
7.Unstable or life-threatening cardiac arrhythmia.
8.Hospitalization for heart failure within the past year.
9.Known active tuberculosis.
10.A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed).
11.A history of life-threatening pulmonary obstruction.
12.A history of cystic fibrosis.
13.Clinically evident bronchiectasis.
14.A history of significant alcohol or drug abuse.
15.Patients who have undergone thoracotomy with pulmonary resection
16.Patients being treated with oral or patch ß-adrenergics.
17.Patients being treated with oral corticosteroid medication at unstable doses
18.Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator’s opinion will be unable to abstain from the use of oxygen therapy during clinic visits.
19.Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program.
20.Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (Visit 1).
21.Patients with known hypersensitivity to ß-adrenergic drugs, BAC, EDTA, or any other component of the RESPIMAT inhalation solution
22.Pregnant or nursing women.
23.Women of childbearing potential not using a highly effective method of birth control.
24.Patients who have previously been randomized in this study or are currently participating in another study.
25.Patients who are unable to comply with pulmonary medication restrictions prior to randomization.

Study & Design

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