Phase 2
Completed N=102
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
Source: ClinicalTrials.gov NCT01634113 ↗Enrolled (actual)
102
Serious AEs
3.0%
Results posted
Jun 2015
Primary outcomePrimary: Weekly Mean Combined Daytime Asthma Symptom Score — -0.456; -0.535; -0.504 units on a scale — p=0.4963
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weekly Mean Combined Daytime Asthma Symptom Score |
-0.456; -0.535; -0.504 | 0.4963 |
| PRIMARY FEV1 Peak (0-3h) Change From Baseline |
0.158; 0.130; 0.145 | — |
| SECONDARY Weekly Mean Overnight Asthma Symptom Score Response |
-0.671; -0.588; -0.655 | 0.5995 |
| SECONDARY Weekly Percentage of Days Without Asthma Symptoms |
53.151; 55.401; 50.654 | 0.8279 |
| SECONDARY Weekly Percentage of Days With Use of Salbutamol (Albuterol) Rescue Medication |
24.94; 24.23; 24.88 | — |
| SECONDARY Weekly Mean Nighttime Awakenings Due to Asthma Symptoms |
-0.318; -0.257; -0.392 | 0.5869 |
| SECONDARY Trough FEV1 Change From Baseline |
0.060; 0.017; 0.085 | — |
| SECONDARY FEV1 AUC (0-3h) Change From Baseline |
0.104; 0.072; 0.077 | — |
| SECONDARY FVC Peak (0-3h) Change From Baseline |
0.210; 0.136; 0.060 | — |
| SECONDARY Trough FVC Change From Baseline |
0.155; -0.027; -0.050 | — |
| SECONDARY FVC AUC (0-3h) Change From Baseline |
0.164; 0.035; 0.003 | — |
| SECONDARY Individual FEV1 Measurements |
0.06; 0.02; 0.09; 0.11; 0.03; 0.12 | — |
| SECONDARY Individual FVC Measurements |
0.16; -0.03; -0.05; 0.13; 0.04; 0.06 | — |
Eligibility Criteria
Inclusion criteria
- 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.
- Male or female patients between 1 and 5 years of age.
- 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)
- 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).
- 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.
- 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
- Patients with a significant disease other than asthma.
- 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.
- 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, including cardiac arrhythmia requiring intervention (e.g. pacemaker implantation) 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.
- Patients with clinically significant lung diseases other than asthma.
- Alternative causes (other causes than asthma) that can lead to respiratory symptoms of wheeze, cough and shortness of breath.
- 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 6 weeks prior to the screening visit (Visit 1).
Further exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT01634113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.