An Open-Label Randomized Pilot Trial to Evaluate Tolerability, Safety and Applicability of AKITA Inhaled Budesonide Suspension in Children aged 3-11 years with Mild to Moderate Asthma - SCIPE-001 – Safe Corticosteroid Inhalation in Pediatrics

• Conditions: 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: 12.1Level: LLTClassification code 10003561Term: Asthma, unspecified

• Registration Number: EUCTR2010-023981-27-DE
• Lead Sponsor: Activaero GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-25
• Last Update Posted: 22 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified