Moderate persisten asthma MedDRA version: 14.1 Level: LLT Classification code 10003560 Term: Asthma NOS System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: TIOTROPIUM BROMIDE
CAS Number: 139404-48-1
Current Sponsor cod
Sponsors
Boehringer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria are: 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 at a stable medium dose, either as mono treatment or in combination with another controller medication, for at least 4 weeks before Visit 1. While the LTRA is permitted throughout the trial, the LABA has to be stopped at least 24 hours prior to Visit 1, as no LABAs are permitted during screening and treatment period of this trial. 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: 381 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: Exclusion criteria are: 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 hospitalized 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 girl with a positive urine pregnancy test at Visit 1. 11. Postmenarchal girl of child-bearing potential not using a highly effective method of birth control. 12. Patients who have been treated with anti-IgE treatment within the last six months prior to Visit 1 and/or during the screening period. 13. Patients who have been treated with systemic corticosteroids within four weeks prior to Visit 1. 14. Patients who have been treated with systemic beta-adrenergics within four weeks prior to Visit 1. 15. Patients who have been treated with oral beta-blocker medication within four weeks prior to Visit 1 and/or during the screening period. 16. 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. 17. Patients who have been treated with long-acting theophylline preparations within four weeks prior to Visit 1 and/or during the screening period or who have been treated with short-acting theophylline preparations within two weeks prior to Visit 1. 18. 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. 19. 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. 20. Patients who have previously been randomised in this trial or are currently participating in another trial. 21. Patients with any acute asthma exacerbation or respiratory tract infection in the four weeks prior to Visit 1 and /or in four weeks prior to Visit 2. In case of an asthma deterioration occurring in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2, the visit must be postponed. 22. Patients requiring six or more puffs of rescue medication per day on more than two consecutive days in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2. In case of an asthma deterioration occurring in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2, th
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 24 weeks of treatment.;Secondary Objective: To evaluate efficacy of tiotropium with regard to other efficacy endpoints after 24 and 48 week of treatment, and to evaluate the long-term safety of tiotropium of a 48 week treatment, 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: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 24 and 48 weeks;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 ofthe forced vital capacity (FVC) response Individual in-clinic forced expiratory volume in one second (FEV1) response and forced vital capacity (FVC) response Asthma control assessed by Asthma Control Questionnaire (ACQ-IA) Number of responders assessed by Asthma Control Questionnaire (ACQ-IA) Quality of life assessed by Paediatric Asthma Quality of Life Questionnaire (PAQLQ(S)) Use of rescue medication Change from baseline in mean weekly pre-dose morning and evening peak expiratory flow (PEF) measured by patients at home Change from baseline in 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 | — |
Countries
Bulgaria, Germany, Guatemala, Hungary, Korea, Republic of, Latvia, Lithuania, Norway, Portugal, Romania, Russian Federation, Sweden, Ukraine, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed