EUCTR2017-003330-91-BG
Active, not recruiting
Phase 1
A pharmacokinetic and pharmacodynamic, randomised, single dose, cross-over, partially blinded study to compare the systemic exposure and the efficacy of a fixed-dose combination of Budesonide-Salmeterol DPI capsule 75-25 µg, Budesonide-Salmeterol DPI capsule 75-12.5 µg, Budesonide-Salmeterol DPI capsule 75-6.25 µg delivered by the Axahaler® versus Serevent® Diskus® 50 µg + Pulmicort® Turbohaler® 100µg co-administration in asthmatic children
aboratoires SMB S.A.0 sites48 target enrollmentOctober 2, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Regular Treatment of Asthma
- Sponsor
- aboratoires SMB S.A.
- Enrollment
- 48
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.1\.Male or premenarchal female subjects aged between 6 and 11 years, inclusive.
- •2\.Caucasian.
- •3\.Asthma diagnosed according to the GINA guidelines based on symptoms typical of childhood asthma, within at least 3 months prior to screening.
- •4\.Subject presenting an increase in FEV1 of at least 12% of the FEV1 predicted value at reversibility test after 200µg of salbutamol at screening visit. If the level of reversibility is not achieved at screening, 1 repeat measurement of reversibility is allowed during the screening period within seven days after Visit 1 if there is reasonable belief that the patient can achieve the expected reversibility.
- •5\.Patients not weighing less than 19 kg
- •6\.Body mass index (BMI) within the 5th to 95th percentile of the BMI charts/tables recommended by the world health organization (WHO) based on stature\-for\-age and weight\-for\-age and by gender. (Charts presented in appendix 18\.6\)
- •7\.Present a peak inspiratory flow \=60L/min with the Axahaler®
- •8\.Able to comply with all study procedures, including the use of study inhalers (AXAHALER®, DISKUS®, TURBOHALER®) and spirometer. Note: Since formal training and test for the correct handling of the DISKUS® and TURBOHALER® inhalers could not be provided the Investigator should check if the child understands the instructions provided for the inhalers use and is aware of their proper use. Willing to withhold the use of short acting ß\-agonists for at least 6 hours prior to the screening visit and at least 6 hours prior to each study visit.
- •9\.Written informed consent for the patient to participate in the study by the parent(s) or legal guardian(s) as applicable and if possible \- a written assent by the patient.
- •Are the trial subjects under 18? yes
Exclusion Criteria
- •1\.Drug addiction or excessive use of xanthine containing beverages (5 cups of tea, coffee, cacao, cola, ice tea)
- •2\.Severe, life\-threatening asthma or hospitalisation for an asthma exacerbation within 3 months prior to the screening visit and hospitalisation for a related disorder (pneumothorax, bronchopneumonia etc) in the past 3 months
- •3\.Evidence of any unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, hepatic, renal, gastrointestinal, neurological or psychiatric abnormality, or disease
- •4\.Respiratory tract infection requiring treatment with antibiotics within 4 weeks prior to the screening visit
- •5\.Any significant upper and lower respiratory infection (other than asthma) within the previous 4 weeks before screening visit
- •6\.Pure seasonal asthma and/ or a history of seasonal exacerbation of asthma
- •7\.Use of any of the prohibited medications as detailed in the concomitant medication section 10\.9
- •8\. Clinical evidence of candidiasis or other fungal airway infection at the screening visit
- •9\.Participation in any other clinical trial within 3 months of the screening visit
- •10\.Blood donation within 3 months before the screening visit
Outcomes
Primary Outcomes
Not specified
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