Asthma MedDRA version: 14.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Boehringer Ingelheim
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All patients' parents (or legally accepted caregivers) must sign and date an informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in the trial. Where appropriate, participants should assent to enroll in the study. 2. Male or female outpatients between 1 and 5 years of age. 3. By a physician documented (at least 6 month) history of persistent asthma symptoms, including (but not limited to) wheezing, cough, and/or shortness of breath. 4. For patients aged 5 years and capable of performing technically acceptable PFTs: documented impaired lungfunction. 5. All patients must have been on maintenance treatment with an inhaled corticosteroid at a stable dose, either as mono treatment or in combination with another controller medication, for at least 4 weeks before Visit 1. 6. All patients must be symptomatic (partly controlled) as defined by the GINA guideline for children aged 5 years and younger in the week prior to Visit 1 (screening) and in the week prior to randomisation (Visit 2). 7. Patients must be able to inhale from the Respimat® inhaler (with or without spacer). 8. Patients and parents/guardians must be able to perform all trial related procedures correctly, including diligently filling out the Paediatric Asthma Caregiver Diary. 9. Parents/guardians must be literate and either one or both (depending on local requirements) must be able to accompany their child to the clinic for all visits. Are the trial subjects under 18? yes Number of subjects for this age range: 102 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. 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. 2. Patients with clinically relevant abnormal screening haematology or blood chemistry will be excluded if the abnormality defines a significant disease as defined in exclusion criterion 1. 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 (in the opinion of the investigator), including cardiac arrhythmia requiring intervention (e.g. pacemaker implantation) 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. 6. Patients with clinically significant lung diseases other than asthma, such as, but not limited to, the following diagnoses: cystic fibrosis, vascular ring or sling, tracheo(broncho)malacia, or bronchopulmonary dysplasia. 7. Alternative causes (other causes than asthma) that can lead to respiratory symptoms of wheeze, cough and shortness of breath, such as , but not limited to, transient viral infection, primary immunodeficiency, congenital heart disease, parasitic disease, vocal cord dysfunction and foreign body aspiration. 8. Patients with known active tuberculosis. 9. Patients who have undergone thoracotomy with pulmonary resection. 10. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit (Visit 1). 11. Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other components of the tiotropium inhalation solution. 12. Patients who are unable to comply with pulmonary medication restrictions prior to Visit 1 and/or prior to Visit 2. 13. Patients with any acute asthma exacerbation or respiratory tract infection in the four weeks prior to Visit 1. 14. Patients who have previously been randomised in this study or are currently participating in another study. 15. Patients requiring salbutamol/albuterol as asthma rescue medication (6 or more puffs by MDI or three or more nebulized treatments per day on more than two consecutive days) during the screening period. 16. Patients with known narrow-angle glaucoma, or any other disease where anticholinergic treatment would be medically contraindicated (in the opinion of the investigator). 17. 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. Creatinine clearance will be calculated according to Schwartz Formula.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to evaluate the safety and efficacy of two doses of tiotropium inhalation solution delivered via the Respimat® inhaler once daily in the afternoon in patients (1 to 5 years old) with (moderate and severe) persistent asthma on top of adequate ICS treatment.;Secondary Objective: No secondary objectives have been specified in the protocol;Primary end point(s): Primary end point for all patients: • Combined PACD daytime asthma symptom score: change from baseline in mean daily daytime score in the last week of the 12 week treatment period. Co-primary end point for children aged 5 years: Only applicable for patients able to perform technically acceptable (and reproducible) PFTs. • FEV1 Peak0-3h response within 3 hours post afternoon dosing at the end of the 12 week treatment period.;Timepoint(s) of evaluation of this end point: For both end points: at 12 weeks treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints for all patients: 1. Overnight PACD asthma symptom score: change from baseline in mean daily overnight score in the last week of the 12 week treatment period. 2. Percentage of days without asthma symptoms during the 12-week treatment period. 3. Percentage of days with use of PRN salbutamol (albuterol) rescue medication during the 12-week treatment period. 4. Nighttime awakenings due to asthma symptoms as assessed by the patient’s (additional) diary card. Additional secondary endpoints for children aged 5 years: Only applicable for patients able to perform technically acceptable (and reproducible) PFTs. 5. Trough FEV1 response at the end of the 12 week treatment period. 6. FVC Peak0-3h response and trough FVC response determined at the end of the 12-week treatment period. 7. FEV1 (AUC0-3h) response and FVC (AUC0-3h) response at the end of 12 weeks treatment period. 8. Individual in-clinic FEV1 and FVC measurements (response) at the end of the 12-week treatment period.;Timepoint(s) of evaluation of this end point: 1. Last week of 12 week treatment period 2. During 12 week treatment period 3. During 12 week treatment period 4. During 12 week treatment period 5. At 12 weeks of treatment 6. At 12 weeks of treatment 7. At 12 weeks of treatment 8. At 12 weeks of treatment | — |
Countries
Belgium, Finland, Germany, Korea, Republic of, Latvia, Lithuania, Malaysia, Netherlands, Peru, Philippines, Ukraine, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed