Allergic or non-allergic mild to moderate asthma in children aged three to eleven years. Affected children need to suffer from mild to moderate asthma according to ATS definition at least for 6 months and need to be treated for at least for three months with inhaled corticosteroids before date of screening. MedDRA version: 12.1 Level: LLT Classification code 10003561 Term: Asthma, unspecified
Conditions
Interventions
Trade Name: 1) BudenoBronch mit der Stärke 1mg/2ml mit der Verwendung des AKITA Jet nebulizer
Pharmaceutical Form: Nebuliser suspension
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentra
Sponsors
Activaero GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written informed consent performed by parents or legal representatives of the child prior to the performance of any study-related procedures. Verbal assent of the child if in the Investigator’s opinion the child is capable of giving the assent. 2) Age = 3 and = 11 year of age 3) Diagnosis of mild-to-moderate asthma (ATS definition, either allergic or non-allergic) for = 6 months and currently stable Asthma treated for at least 3 months with inhaled (ICS) corticosteroids (MDI/DPI). Current ICS treatment will be suspended during the treatment phase of the trial. Treatment with additional leukotriene antagonists (e.g. Montelukast) is allowed and remains unchanged throughout the study. 4) FEV1 = 50% predicted at the Screening or Baseline Visit (children aged 6 years or older and able to perform spirometry) 5) Documented increase of at least 12% in absolute FEV1 within 15-30 minutes after the use of inhaled Salbutamol at the Screening Visit or within 6 months prior to Screening (children aged 6 years or older and able to perform spirometry). 6) A negative urine pregnancy test must be available for any girl of childbearing potential at screening and, in addition, a negative urine pregnancy test must be present at randomization (prior to randomization to one of the treatment groups!) Are the trial subjects under 18? yes Number of subjects for this age range: 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) History of allergy or adverse experience with Budesonide 2) Upper respiratory tract infection within 4 weeks of Screening 3) Emergency room visit for treatment of asthma exacerbation within 4 weeks of Screening 4) Hospitalization for asthma within 3 months of Screening 5) Use of inhaled LABA, theophylline, anti-IgE, or oral corticosteroids within 3 months of Screening. 6) Treatment with other investigational asthma treatment within 30 days prior to Screening. 7) Evidence of chronic lung diseases other than asthma, including but not limited to: cystic fibrosis, allergic bronchopulmonary aspergillosis (ABPA), chronic bronchitis and emphysema 8) History of medication noncompliance 9) History of significant medical illness or condition that in the Investigator’s opinion places the subject at undue risk by participating in the study 10) Past episode of anaphylaxis with severe respiratory symptoms 11) Taking oral or i.v. corticosteriods for any disease indication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objectives are to evaluate the airway tolerability, safety and applicability of nebulized Budesonide delivered with AKITA in children aged 3-11 years with asthma in comparison to delivery with conventional jet nebulizer. 1) To evaluate the airway tolerability of nebulized Budesonide 2) To monitor the safety of nebulized Budesonide as described by the safety variables. It is the general idea that, given the deposition efficacy and consistency of Akita, along with adherence monitoring, asthma control can be achieved in these children with a substantially lower nominal dose, shorter treatment times, and negligible oropharyngeal side effects. 3) Efficacy: To conduct exploratory measures of FEV1, asthma control and exhaled NO for descriptive purposes. 4) To observe the handling and applicability of AKITA JET Technology, to monitor differences in the application, problems and mistakes during application of AKITA Jet nebulizer.;Secondary Objective: 1)From which age on a controlled positive airway pressure application/airflow control of inhaled budesonide is being tolerated? 2)Do children = 4 years tolerate and correctly perform inhalation via mouthpiece? 3)Can/will they do this consistently at home? 4)What features of a controlled inhalation system are needed to facilitate its usage for inhalation in children? 5)Which volumes of inhalation and which breathing flow rates will be tolerated? 6)What minimal therapy time can be achieved? 7)To what extent do device training / feedback influence the outcome of the inhalation? 8)How high is treatment adherence? 9)To what extent will adherence feedback affect the outcome? 10)Is 125 µg Budesonide BID (with 50-70µg deposited per day) sufficient to control asthma symptoms? 11)What changes in a)in FEV1 during treatment with either AKITA JET or conventional jet nebulizer b)asthma symptom score c)exhaled NO as a marker for inflammatory processes can be observed/achieved?;Primary end point(s): The study will be conducted | — |
Countries
Germany
Outcome results
None listed