Asthma
Conditions
Interventions
Product Name: Tiotropium + BI 54903, inhalation solution
Product Code: Ba 679 + BI 54903, inhalation solution
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: Tiotropium
Current Sponsor c
Sponsors
Boehringer Ingelheim
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Outpatients of either sex, aged 18-75 years (inclusive). •Never-smokers or ex-smokers (for at least 1 year) with a smoking history of =65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: -Patients with a recent history (i.e. six months or less) of myocardial infarction. -Patients requiring more than 8 puffs of salbutamol MDI on at least 2 or more consecutive days during the run-in period. -Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the six weeks prior to the firs screening visit (Visit 1). -Patients who have been hospitalised for cardiac failure during the past year. -Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year. -Patients with lung diseases other than asthma (e.g. COPD). -Patients with known active tuberculosis. -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. -Patients with significant alcohol or drug abuse in the opinion of the investigator within the past two years. -Pregnant or nursing woman. -Women of childbearing potential not using a highly effective method of birth control. -Patients who have taken an investigational drug within four weeks prior to Visit 1. -Patients with known hypersensitivity to anticholinergic drugs, ciclesonide or any other component of the trial medications. -Patients with any asthma exacerbation or any lower or upper respiratory tract infection 4 weeks prior Visit 1. -Patients who have previously been randomised in this trial or are currently participating in another trial. -patients treated with oral corticosteroid, long-acting anticholinergic agent, beta-blocker medication 4 weeks prior Visit 1 or cromone, methylxanthines 2 weeks before Visit 1, or Anti-IgE antibodies 6 months prior Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate and to compare the lung function response (FEV1 AUC0-12h) and systemic exposure of three doses of tiotropium formulated as FDC with BI 54903 (as ethanolic inhalation solution) with the free combination of three doses of tiotropium (as aqueous inhalation solution) plus BI 54903 (as ethanolic solution).;Secondary Objective: Peak FEV1, FEV1 AUC0-24h, FEV1 AUC12-24h, To evaluate and to compare the lung function response (Peak FEV1, FEV1 AUC0-24h, FEV1 AUC12-24h) and systemic exposure of three doses of tiotropium formulated as FDC with BI 54903 (as ethanolic inhalation solution) with the free combination of three doses of tiotropium (as aqueous inhalation solution) plus BI 54903 (as ethanolic solution).;Primary end point(s): Primary endpoint: • FEV1 AUC0-12h ;Timepoint(s) of evaluation of this end point: pre-dose and 30, 60 min, 2, 3, 4, 6, 8, 10, 12 hours post-dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Peak FEV1, FEV1 AUC0-24h, FEV1 AUC12-24h, Other secondary endpoints: •24-h FEV1 profile •Peak FVC, FVC AUC0-12h, FVC AUC0-24h, FVC AUC12-24h, •24-h FVC profile ;Timepoint(s) of evaluation of this end point: pre-dose and 30, 60 min, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 h post-dose | — |
Countries
Argentina, Serbia, Slovakia, South Africa, Ukraine
Contacts
Public ContactQRPE PSC CT information Disclosure
Boehringer Ingelheim Pharma GmbH & Co.KG
Outcome results
None listed