Severe persistent asthma MedDRA version: 14.1 Level: LLT Classification code 10003560 Term: Asthma NOS System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Boehringer Ingelheim RCV GmbH & Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All patients’ parent(s) (or legal guardian) must sign and date an informed consent prior to participation in the trial. In addition, an informed assent suitable for this age group has to be obtained from patients. A separate informed consent/assent is required for pharmacogenomic sampling. 2. Male or female patients between 6 and 11 years of age. 3. All patients must have at least a 6-month history of asthma. 4. All patients must have been on maintenance treatment with an inhaled corticosteroid either at stable high dose in combination with another controller medication, OR at stable medium dose in combination with two other controller medications, for at least 4 weeks before Visit 1. 5. All patients must be symptomatic (partly controlled) at Visit 1 and prior to randomisation at Visit 2 as defined by an Asthma Control Questionnaire (ACQ-IA) mean score >= 1.5. 6. All patients must have a pre-bronchodilator forced expiratory volume in one second (FEV1) >= 60% and = 12% 15 to 30 minutes after 200 mcg salbutamol/albuterol. 9. Patients must be able to use the Respimat inhaler correctly. 10. Patients must be able to perform all trial related procedures including technically acceptable pulmonary function tests and use of electronic diary/peak flow meter (diary compliance of at least 80% is required). Are the trial subjects under 18? yes Number of subjects for this age range: 375 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no 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. Patients with a clinically relevant abnormal haematology or blood chemistry at screening. 3. Patients with a history of congenital or acquired heart disease, or patients who have been hospitalised for cardiac syncope or failure during the past year. 4. Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year. 5. Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. 6. Patients with known active tuberculosis. 7. Patients who have undergone thoracotomy with pulmonary resection. 8. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the six weeks prior to Visit 1. 9. Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other components of the inhalation solution used with the Respimat inhaler. 10. Pregnant or nursing female patients, including postmenarchal girls with a positive urine pregnancy test at Visit 1. 11. Postmenarchal girls of child-bearing potential not using a highly effective method of birth control. 12. Patients who have been treated with systemic corticosteroids within four weeks prior to Visit 1. 13. Patients who have been treated with systemic beta-adrenergics within four weeks prior to Visit 1. 14. Patients who have been treated with oral beta-blocker medication within four weeks prior to Visit 1 and/or during the screening period. 15. Patients who have been treated with inhaled long-acting anticholinergics or systemic anticholinergic treatment within four weeks prior to Visit 1 and/or during the screening period, or who have been treated with inhaled short-acting anticholinergics within two weeks prior to Visit 1. 16. Patients who have been treated with short-acting theophylline preparations within two weeks prior to Visit 1. 17. Patients who have been treated with non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy within four weeks prior to Visit 1 and/or during the screening period. 18. Patients who have taken an investigational drug within six half lives according to the investigator’s information, or four weeks (whichever is greater) prior to Visit 1 and/or during the screening period. 19. Patients who have previously been randomised in this trial or are currently participating in another trial. 20. Patients with any acute asthma exacerbation or respiratory tract infection in the four weeks prior to Visit 1 and/or during the screening period. 21. Patients requiring six or more puffs of rescue medication per day on more than two consecutive days during the screening period. 22. Patients who are unable to comply with pulmonary medication restrictions prior to randomisation. 23. Patients with a known narrow-angle glaucoma, or any other disease where anticholinergic treatment is contraindicated. 24. Patients with moderate to severe renal impairment, as defined by a creatinine clearance <50 mL/min/1.73 m2 BSA, as tiotropium is a predominantly renally excreted drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate superiority of tiotropium (5 mcg and possibly 2.5 mcg once daily in the evening) over placebo with regard to the primary pulmonary function endpoint after 12 weeks of treatment.;Secondary Objective: To evaluate efficacy of tiotropium with regard to other efficacy endpoints, and to evaluate the safety of tiotropium, compared to placebo, as add-on controller therapy on top of usual care in this patient population.;Primary end point(s): Peak forced expiratory volume in one second response within 3 hours post dosing (FEV1 peak0-3h response).;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Trough forced expiratory volume in one second (trough FEV1) response. Peak forced vital capacity response within 3 hours post dosing (FVC peak0-3h response). Trough forced vital capacity (trough FVC) response. Area under the curve from zero to 3 hours of the forced expiratory volume in one second (FEV1) response and area under the curve from zero to 3 hours of the forced vital capacity (FVC) response. Individual in-clinic forced expiratory volume in one second (FEV1) response and forced vital capacity (FVC) response. Asthma control as assessed by Asthma Control Questionnaire (ACQ-IA). Number of responders assessed by Asthma Control Questionnaire (ACQ-IA). Use of rescue medication. Change from baseline in the mean weekly pre-dose morning and evening peak expiratory flow (PEF) measured by patients at home. Change from baseline in the mean weekly pre-dose morning and evening forced expiratory volume in one second (FEV1) measured by patients at home. Change from baseline in the absolute difference between morning and evening peak expiratory flow (PEF) value divided by the mean of these two values (weekly means will be compared). Asthma symptoms assessed by the patient’s electronic diary.;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Argentina, Belgium, Brazil, Czech Republic, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Romania, Russian Federation, Slovakia, Ukraine, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed