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

• Register: EUCTR
• Last refreshed on: 30 September 2013
• Main ID: EUCTR2009-010668-40-IT
• Date of registration: 22/12/2011
• Prospective Registration: No
• Primary sponsor: BOEHRINGER ING.
• Public title: Study to assess the efficacy and safety of tiotropium+olodaterol fixed dose combination in patients with COPD
• Scientific title: A randomised, double-blind, parallel group study to assess the efficacy and safety of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 micrograms / 5 micrograms; 5 micrograms / 5 micrograms) (delivered by the Respimat Inhaler) compared with the individual components (2.5 micrograms and 5 micrograms tiotropium, 5 micrograms olodaterol) (delivered by the Respimat Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD) - TOnado 1
• Date of first enrolment: 12/10/2011
• Target sample size: 3220
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-010668-40
• 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: yes Other specify the comparator: - same IMP used at different dosage Number of treatment arms in the trial: 5

Countries of recruitment

Argentina, Australia, Canada, China, Czech Republic, Denmark, Estonia, Finland, Germany, Guatemala, Hungary, India, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Portugal, Réunion, Russian Federation, Slovenia, Turkey, United States

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:
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 COPD and must meet the following spirometric criteria: Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1< 80% of predicted normal (ECSC; GOLD II - IV 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. 5. Patients must be able to -perform technically acceptable pulmonary function tests , -perform technically acceptable PEF measurements, -maintain records (Patient Daily e-Diary) during the study period , -perform all other assessments (e.g. complete self administed questionnaires), as required in the protocol. 6.Patients must be able to inhale medication in a competent manner from the RESPIMAT inhaler and from a metered dose inhaler (MDI).
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 2000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1220

Exclusion criteria:
1.Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study. 2.Patients with a, in the opinion of the investigator, clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT >x2 ULN, SGPT >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN will be excluded regardless of clinical condition (a repeat laboratory evaluation will not be conducted in these patients). 3. 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. If a patient has a total blood eosinophil count >=?600/mm**3, source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition. Patients with any of the following conditions: 4. A diagnosis of thyrotoxicosis (due to the known class side effect profile of beta2- agonists). 5. A diagnosis of paroxysmal tachycardia (>100 beats per minute) (due to the known class side effect profile of beta2-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 (patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1). 16. Patients being treated with oral or patch beta-adrenergics. 17. Patients being treated with oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day. 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 beta-adrenergic and/or anticholinergics 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. Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years. 24. Patients who have previously been randomized in this study or are currently participating in another stu

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

Health Condition(s) or Problem(s) studied

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

Patients with Chronic Obstructive Pulmonary Disease (COPD)
MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Product Name: Tiotropium 1.25microgram/Olodaterol 2.5microgram
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: TIOTROPIUM
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 1.25-
INN or Proposed INN: olodaterol
Current Sponsor code: BI 1744 CL
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 2.5-

Product Name: Tiotropium 2.5microgram/Olodaterol 2.5microgram
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: TIOTROPIUM
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 2.5-
INN or Proposed INN: olodaterol
Current Sponsor code: BI 1744 CL
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 2.5-

Trade Name: Spiriva Respimat 2.5 microgram
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: TIOTROPIUM
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 2.5-

Product Name: tiotropium 1.25 microgram
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: TIOTROPIUM
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 1.25-

Product Name: olodaterol 2.5 microgram
Product Code: BI 1744
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: olodaterol
Current Sponsor code: BI 1744
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 2.5-

Primary Outcome(s)

Primary end point(s): There are three primary endpoints in this study which are assessed after 24 weeks of treatment: -FEV1 AUC0-3h response -Trough FEV1 response -SGRQ (total score).

Main Objective: The primary objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol fixed dose combination ((2.5 micrograms / 5 micrograms; 5 micrograms/ 5 micrograms) (delivered by the Respimat Inhaler) compared with the individual components (2.5 and 5 micrograms tiotropium, 5 micrograms olodaterol) (delivered by the Respimat Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD).

Secondary Objective: -

Timepoint(s) of evaluation of this end point: after 24 weeks of treatment

Secondary Outcome(s)

Secondary end point(s): TDI focal score

Timepoint(s) of evaluation of this end point: after 24 weeks of treatment

Secondary ID(s)

1237.5

2009-010668-40-NL

Source(s) of Monetary Support

Boehringer Ingelheim Italia S.p.A.