Asthma
Conditions
Interventions
Product Name: Olodaterol & BI 54903, inhalation solution
Product Code: BI 1744 & BI 54903, inhalation solution
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: Olodaterol
Current Sponsor
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All patients must sign and date an Informed Consent Form consistent with ICH-GCP guidelines and local legislation prior to trial related procedures, which includes medication washout and restrictions. 2. Male or female patients aged at least 18 to 75 years. 3. All patients must have a diagnosis of asthma by a physician at least three months prior to screening Visit 1. The diagnosis of asthma must be according to the 2009 Global Initiative for Asthma (GINA) Guidelines (P10-03196 ). The initial diagnosis of asthma must have been made before the age of 40 years. 4. All patients must have been on maintenance treatment with a low or medium dose ICS with or without LABA, stable dose of inhaled corticosteroids (see Appendix 10.4) (alone or in a fixed combination with a LABA) for at least for 6 weeks prior to Visit 1. 5. All patients must have at Visit 1 (screening) an ACQ-6 (see Appendix 10.5) mean score of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with a significant disease other than asthma. 2. 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 trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patient's ability to participate in the trial. 3. Patients with a clinically relevant abnormal screening (Visit 1) haematology or blood chemistry if the abnormality defines a significant disease as defined in exclusion criterion 1. 4. Patients with a recent history (i.e. six months or less) of myocardial infarction. 5. Patients who have been hospitalised for cardiac failure during the past year. 6. Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year. 7. Patients with lung diseases other than asthma (e.g. COPD). 8. Patients with known active tuberculosis. 9. Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed. 10. 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. 11. Patients with significant alcohol or drug abuse in the opinion of the investigator within the past two years. 12. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to Visit 1 (screening). 13. Patients with known hypersensitivity to LABA drugs, ciclesonide, BAC, EDTA, salmeterol or any other components of the study medication delivery systems. 14. Pregnant or nursing woman. 15. Women of childbearing potential not using a highly effective method of birth control. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner. Barrier methods of contraception are accepted if condom or occlusive cap are used together with spermicides (e.g. foam, gel). Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation/salpingectomy, or post-menopausal for at least two years. 16. Patients who have taken an investigational drug within four weeks prior to Visit 1. 17. Patients who have been treated with beta-blocker medication - within four weeks prior to Visit 1 and/or - during the run-in period (period between Visit 1 and Visit 2). 18. Topical cardio-selective beta-blocker eye medications for non-narrow angle glaucoma are allowed. 19. Patients who have been treated with short or long-acting anticholinergic - within four weeks prior to Visit 1 and/or - during the run-in period (period between Visit 1 and Visit 2). 20. Patients who have been treated with oral or patch beta-adrenergics - within four weeks prior to Visit 1 and/or - during the run-in period (period between Visit 1 and Visit 2) 21. Patients who have been treated with oral corticosteroids - within four weeks prior to Visit 1 and/or - during the run-in period (period between Visit 1 and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the olodaterol dose in the DFDC EIS with BI 54903 which is equivalent in bronchodilator efficacy and systemic exposure to the reference dose in AIS (5µg) in free combination with BI 54903 EIS.;Secondary Objective: ;Primary end point(s): The primary efficacy endpoint is FEV1 (AUC0-12h).;Timepoint(s) of evaluation of this end point: 0:05, 0:15, 01:00, 02:00, 03:00, 04:00, 06:00, 08:00, 10:00, 12:00 hours after administration of study medication. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoint are the following: - FEV1 (AUC0-24h), FEV1 (AUC12-24h) and peak FEV1.;Timepoint(s) of evaluation of this end point: 0:05, 0:15, 01:00, 02:00, 03:00, 04:00, 06:00, 08:00, 10:00, 12:00, 14:00, 22:00, 23:00, 24:00 hours after administration of study medication and 12:00, 14:00, 22:00, 23:00, 24:00 hours after administration of study medication, respectively. | — |
Countries
Canada, Croatia, Germany, Russian Federation
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed