A research study to evaluate efficacy and safety of tiotropium inhalation solution (doses of 1.25 µg, 2.5 µg and 5 µg) delivered via Respimat® inhaler once daily in the evening in children 6 to 11 yrs old with asthma.
- Conditions
- Moderate persistent asthma in children 6 to 11 years oldMedDRA version: 13.1Level: LLTClassification code 10003555Term: Asthma bronchialSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2010-022458-18-HU
- Lead Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 92
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, i.e. prior to any study procedures including medication wash-out and restrictions. In addition, an informed assent suitable for this age group has to be obtained from patients. A separate informed consent is required for pharmacogenomic sampling (consent for pharmacogenomic sampling is not a prerequisite for study entry).
2. Male or female patients between 6 and 11 years of age (up to 1 day prior to their 12th birthday at Visit 1).
3. All patients must have at least a 6-month history of asthma at the time of enrolment into the trial.
4. All patients must have been on maintenance treatment with inhaled corticosteroids at a stable medium dose, either as mono treatment or in combination with a LABA or leukotriene modifier for at least 4 weeks before Visit 1.
5. All patients must be symptomatic (partly controlled) at Visit 1 (screening) and prior to randomisation at Visit 2 as defined by an ACQ mean score of =1.5.
6. All patients must have a pre-bronchodilator FEV1 =60% and =90% of predicted normal at Visit 1. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator) as compared to Visit 2 (pre-dose) must be within ±30%.
7. All patients must have an increase in FEV1 of =12% 15 to 30 min. after 200 mcg salbutamol (albuterol) at Visit 1.
8. Patients must be able to inhale from the Respimat® inhaler correctly.
9. Patients must be able to perform all trial related procedures including technically acceptable spirometric manoeuvres according to ATS/ERS standards and the use of the electronic diary/peak flow meter.
Are the trial subjects under 18? yes
Number of subjects for this age range: 92
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
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, if the abnormality defines a significant disease as defined in exclusion criterion 1. For participation in PK sampling, a haemoglobin of less than 11.3 g/dL will be regarded as exclusion criterion.
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, catheter ablation etc.) or a chnage 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 clinically significant lung diseases other than asthma, such as CF or bronchopulmonary dysplasia.
7. Patients with known active tuberculosis.
8. Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1.
9. 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).
10. Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other components of the tiotropium inhalation solution.
The following will be rarely applicable in this age group, but are mentioned for safety reasons:
11. Pregnant or nursing adolescent female patients, including female patients with a positive ßHCG (serum pregnancy) testing at screening (Visit 1).
12. Sexually active female patients of child-bearing potential not using a highly effective method of birth control. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year).
Note: sexual abstinence is deemed to be a highly effective contraception method.
13. Patients who have taken an investigational drug within four weeks or six half-lives (whichever is greater) prior to Visit 1.
14. Patients who have been treated with long-acting anticholinergics (e. g. tiotropium - Spiriva®) or systemic anticholinergic treatment such as spasmolytics within 4 weeks prior to screening (Visit 1).
15. Patients who are unable to comply with pulmonary medication restrictions prior to randomisation.
16. Patients who have been treated with Anti-IgE treatment (Omalizumab –Xolair®) within the last 6 months prior to screening.
17. Patients who are being treated with beta-blocker medication. Topical cardio-selective beta-blocker eye medications for treatment of non-narrow angle glaucoma are allowed.
18. Patients who have been treated with systemic (oral or i.v.) corticosteroids within 4 weeks prior to screening (Visit 1).
19. Patients who have been treated with long-acting theophylline preparations within 4 weeks prior to screening (Visit 1) or during the run-in period.
20. Patients who have been treate
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method