Asthma MedDRA version: 8.1 Level: LLT Classification code 10003555
Conditions
Sponsors
Merck Generics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be eligible for enrolment into the study if all of the following criteria are met at the screening visit (Visit 1): 1. Male and female paediatric patients aged 4 to 16 years (inclusive) 2. Documented clinical history of reversible obstructive airways disease of at least 2 weeks duration at the time of the Visit 1 3. Inhaled corticosteroid naïve 4. Ability to correctly use the pMDIs (this can be with or without the aid of a device spacer as appropriate, however the use/non-use of a spacer device must remain constant throughout the patient’s participation in the study) 5. Written informed consent/assent for participation in the study from the patient/parent/legal guardian (as appropriate) The following must be demonstrated after withholding use of short-acting ß2- agonists for the preceding 4 hrs. If a patient fails to meet the washout criteria at the screening visit, another appointment should be made to obtain clinical spirometry data: 6. FEV1 between 60% and 90% of the predicted value for their age, height and gender at screening, (refer to section 5.8.3.1.2 of the protocol) Note: Patients must not enter the run-in period without meeting this criterion 7. Reversibility: demonstrated by a = 12% increase in FEV1 = 10 min and up to 15 minutes after inhalation of up to 400 µg salbutamol (Ventolin Evohaler®) via a spacer (refer to section 5.8.3.1.2 of the protocol) Note: Patients with a study-qualifying FEV1 may enter the run-in period without having demonstrated reversibility. Reversibility can be determined at screening, during the run-in period or at the randomisation visit. At the investigator’s discretion, if a patient fails to meet the = 12% threshold, the reversibility tests may be repeated as many times as necessary during this period. Once reversibility has been demonstrated the reversibility test should not be repeated. 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: Patients will be excluded from participation if any of the following apply at screening (Visit 1): 1. Current or prior use of inhaled corticosteroids (for routine control of their asthma) 2. Evidence of an unknown disease requiring further clinical evaluation (e.g. previous laboratory abnormality or a physical examination or vital sign finding) 3. Concomitant severe diseases or diseases which the investigator believes are contraindications for the use of inhaled steroids or which may affect the study outcome measures (e.g., active pulmonary tuberculosis) 4. Suffering from chronic obstructive pulmonary disease (i.e., chronic bronchitis or emphysema) and/or other relevant lung diseases causing variable impairment in lung function 5. Hospitalisation for asthma in the 6 months preceding Visit 1 6. Current or recent (within 3 months of Visit 1) systemic (oral, parenteral or depot) corticosteroid therapy or receipt of more than 3 short courses of systemic corticosteroid therapy in the preceding year 7. Current or recent (within 3 months of Visit 1) use of long-acting ß2-agonists (inhaled, oral or otherwise systemic) 8. Current use of anticholinergics for the relief of asthma symptoms 9. Asthma exacerbations or respiratory tract infection requiring antibiotic treatment during the past 6 weeks 10. Known or suspected hypersensitivity to fluticasone or the excipients of either of the pMDIs 11. Inability to perform lung functions tests 12. Patients who are unlikely to be compliant, take their medication as directed, complete the diary and daily lung testing procedures or attend scheduled clinic visits 13. Evidence of current neoplastic or systemic disease or diagnosed tuberculosis 14. Females who are pregnant or lactating 15. Any females of childbearing potential who are likely to become pregnant during the course of the study who are not using adequate contraception (i.e., contraceptive pill or barrier method) or will not agree to abstain from sexual intercourse during their participation in the study and for a period of 4 weeks following their final administration of study treatments 16. Smokers (current or previous) 17. Evidence of history of alcohol or drug abuse 18. Participation in an investigational drug trial during 30 days preceding Visit 1 19. Employees or relatives of employees of Merck Generics or Omnicare Clinical Research Ltd.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary aim of the study is to evaluate safety and tolerability of the generic formulations in comparison with the reference formulations in terms of vital signs, 24-hour urinary free cortisol levels (expressed as cortisol:creatinine ratio), physical examination and adverse events (including oral candidiasis).;Main Objective: The primary aim of the study is to demonstrate the therapeutic equivalence of a generic formulation of fluticasone propionate, 100 µg twice daily administered from a pressurised metered dose inhaler (pMDI) (Merck Generics) with a reference fluticasone propionate formulation, 100 µg twice daily administered from a reference pMDI in patients with mild to moderate persistent asthma bronchiale.;Primary end point(s): Primary efficacy measure is morning peak expiratory flow rate (PEFR) recorded daily with the Vitalograph® 2110 PEF FEV Diary. The primary efficacy variable is defined as the mean change in morning PEFR from baseline, where the baseline value is defined as the average of the last 7 days of the run-in period (with day 7 being the day before the randomisation visit). All post- randomisation measurements will be used for calculating the post-baseline average. | — |
Countries
Czech Republic, Germany, Hungary
Outcome results
None listed