Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Sever… (NCT01634152) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Severe Persistent Asthma
United States401 participantsStarted 2012-07
Plain-language summary
The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution (2.5 mcg and 5 mcg) delivered via Respimat® inhaler once daily in the evening over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in children (6 to 11 years old) with severe persistent asthma.
Who can participate
Age range6 Years – 11 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Male or female patients between 6 and 11 years of age.
✓. All patients must have at least a 6-month history of asthma.
✓. 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.
✓. 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.
✓. All patients must have a pre-bronchodilator forced expiratory volume in one second (FEV1) \>= 60% and \<= 90% of predicted normal at Visit 1.
✓. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator, considered as 100%) as compared to Visit 2 (pre-dose) must be within ± 30%.
✓. All patients must confirm the diagnosis of asthma by bronchodilator reversibility at Visit 1, resulting in an increase in FEV1 of \>= 12% 15 to 30 minutes after 200 mcg salbutamol/albuterol.
Exclusion criteria
✕. Patients with a significant disease other than asthma.
. Patients with a clinically relevant abnormal haematology or blood chemistry at screening.
✕. 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.
✕. 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 a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years.
✕. Patients with known active tuberculosis.
✕. Patients who have undergone thoracotomy with pulmonary resection.
✕. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the six weeks prior to Visit 1.