Regular Treatment of Asthma MedDRA version: 20.0 Level: LLT Classification code 10003560 Term: Asthma NOS System Organ Class: 100000015470
Conditions
Interventions
Trade Name: Serevent ® Diskus®50µg
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: salmeterol xinafoate
CAS Number: 94749-08-3
Other descriptive name: SALMETEROL XINAFOATE
Concentration un
Sponsors
Laboratoires SMB S.A.
Eligibility
Sex/Gender
All
Inclusion 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 Number of subjects for this age range: 48 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. 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 11. Presence of any other condition or illness, which, in the opinion of the investigator would interfere with optimal participation in the study 12 Patients with any sensitivity or allergy to any of the products (including excipients) used within this clinical trial 13 Patient known to have, or at risk of contracting, human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C or patients with positive virology laboratory tests (HBsAg, HCV Ab, HIV 1+2 Ab) 14 Patients with diabetes mellitus 15 Subjects previously enrolled into the current study. 16 First-degree relative of a study investigator, or of employee of the clinical study site or of the sponsor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the non-inferiority between budesonide-salmeterol DPI capsule 75/25µg and Serevent® Diskus® 50 µg + Pulmicort® Turbohaler® 100µg co-administration by measurement of the bronchodilating effect To assess and compare the systemic exposure of budesonide after administration of the two study products (budesonide-salmeterol DPI capsule 75/25µg versus Serevent® Diskus® 50 µg + Pulmicort® Turbohaler® 100µg co-administration) in asthmatic children aged from 6 to 11 years old, inclusive. ;Secondary Objective: To assess the dose-response of Budesonide-Salmeterol by measuring the bronchodilating effect. To assess and to compare the safety profile of Budesonide-Salmeterol Axahaler® with the Serevent® and the Pulmicort® products. ;Primary end point(s): - Baseline-adjusted area under the curve (AUC) for FEV1 over 12 hours post dosing - the following pharmacokinetic parameter will be considered as primary endpoint for budesonide : AUC0-t/Cmax;Timepoint(s) of evaluation of this end point: - Period I, Period II, Period III, Period IV | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The following parameters will be considered as secondary endpoints: -AUC8, AUC0-30min, AUC0-2h, tmax and t1/2 for budesonide. - Safety criteria includes: - Adverse event profiles - Vital signs (heart rate, SBP, DBP) - Tremor - Serum glucose and potassium measurements - 12-lead ECG measurements - Physical examination + spirometry parameters: - Peak bronchodilatory effect (FEV1 max) - Tmax of FEV1 - FEV1 at 12 hours post dose - PEF max - Baseline adjusted area under the curve (AUC) of PEF from 0 to 12 hours post dosing - PEF at 12 hours post dose - FEV1 % max - Baseline adjusted area under the curve (AUC) of FEV1% from 0 to 12 hours post dosing - FEV1% at 12 hours post dose - FVC max - Baseline adjusted area under the curve (AUC) of FVC from 0 to 12 hours post dosing - FVC at 12 hours post dose - Partial baseline adjusted area under the curve for FEV1 from 0 to 4 hours post dose - Partial baseline adjusted area under the curve for FEV1 from 4 to 8 hours post dose - Partial baseline adjusted area under the curve for FEV1 from 8 to 12 hours post dose - Percentage of responders patients. Responders are defined as those patients who achieved a > 15% increase in PEF over baseline within 4 hours post-dose - Duration of effect. The effect is defined by an increase of at least 15% of the baseline value. ;Timepoint(s) of evaluation of this end point: Screening visit, Period I, Period II, Period III, Period IV (End of study visit) | — |
Countries
Bulgaria
Contacts
Public ContactClinical trial information
Laboratoires SMB S.A.
Outcome results
None listed