Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo in 1 to 5 Year Old Patients With Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: tiotropium-bromide; tiotropium-bromide; placebo
Intervention description: IMP; IMP; placebo matching tiotropium
Intervention MeSH terms: Bromides; Tiotropium Bromide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 102.0
Sex: All
Minimum age: 1 Year
Maximum age: 5 Years
Healthy volunteers: No

Summary:

      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 persistent asthma on top of inhaled
      corticosteroid (ICS) treatment.
    

Eligibility criteria:

        Inclusion criteria:

          1. All patients' parents (or legal guardians) 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 patients 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.
             (persistent = need for inhalation corticosteroid maintenance therapy to control asthma
             symptoms)

          4. For patients aged 5 years and capable of performing technically acceptable Pulmonary
             Function tests (PFTs): documented impaired lung function (i.e. pre-bronchodilator
             Forced Expiratory Volume in 1 second (FEV1) is smaller or equal to 90% of predicted
             normal).

          5. All patients must have been on maintenance treatment with an inhaled corticosteroid at
             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 Global
             Initiative for Asthma (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).

        Further inclusion criteria apply.

        Exclusion criteria:

          1. Patients with a significant disease other than asthma.

          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, 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.

          7. Alternative causes (other causes than asthma) that can lead to respiratory symptoms of
             wheeze, cough and shortness of breath.

          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).

        Further exclusion criteria apply.