Regular treatment of asthma MedDRA version: 20.0 Level: LLT Classification code 10003560 Term: Asthma NOS System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Serevent® Diskus® 50 µg
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Salmeterol xinafoate
CAS Number: 94749-08-3
Concentration unit: µg microgram(s)
Concentration type: equa
Sponsors
Laboratoires SMB S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 200 µg 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 18.5) 7. Able to comply with all study procedures, including the use of study inhalers (Vertical-Haler®, Diskus®, Turbuhaler®) and spirometer. Note: Since formal training and test for the correct handling of the DISKUS® and TURBUHALER® 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. 8. 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: 14 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: The primary objective is to assess and compare the systemic exposure of budesonide and salmeterol after administration of the study products (two dosages of Budesonide-Salmeterol fixed dose combination versus Serevent® Diskus® 50 µg + Pulmicort® Turbuhaler® 100 µg co-administration) using Cmax, AUC8, AUC0-30min, AUC0-2h, tmax and t1/2. ;Secondary Objective: - To assess and compare the pulmonary exposure of Budesonide-Salmeterol fixed dose combination versus Serevent® Diskus® 50 µg + Pulmicort® Turbuhaler® 100 µg co-administration. - To assess and compare the safety profile of Budesonide-Salmeterol fixed dose combination versus Serevent® Diskus® 50 µg + Pulmicort® Turbuhaler® 100 µg co-administration. ;Primary end point(s): The following pharmacokinetic parameters will be considered: - AUC8, AUC0-30min, AUC0-2h, tmax, % of residual AUC and t1/2 for budesonide. - AUC8, AUC0-30min, tmax, % of residual AUC and t1/2 for salmeterol. Cmax and AUC0-t will be considered as primary endpoints ;Timepoint(s) of evaluation of this end point: Period I, Period II, Period III | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following safety endpoints will be considered: - Adverse event profiles - Vital signs (heart rate, SBP, DBP, Respiratory rate) - Tremor - Serum glucose and potassium - Haematology, chemistry and urine standard safety lab parameters - 12-lead ECG measurements - Physical examination ;Timepoint(s) of evaluation of this end point: Screening visit, Period I, Period II, Period III, End of study visit | — |
Countries
Bulgaria
Contacts
Public ContactClinical Trial Information
Laboratoires SMB S.A.
Outcome results
None listed