Asthma Bronchiole MedDRA version: 14.1 Level: LLT Classification code 10003555 Term: Asthma bronchial System Organ Class: 100000004855
Conditions
Interventions
Product Name: Flutiform pMDI 50/5µg
Product Code: Flutiform pMDI 50/5µg
Pharmaceutical Form: Pressurised inhalation, suspension
INN or Proposed INN: Fluticasone Propionate
CAS Number: 80474142
Concent
Sponsors
Mundipharma Research Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and Female subjects 5 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Near fatal or life-threatening (including intubation) asthma within the past year 2. Hospitalisation or an emergency visit for asthma within the past 6 months 3. History of systemic (injectable or oral) corticosteroid medication within 1 month of the screening visit 4. Current or prior non-response or partial response only to an ICS-LABA combination1 5. Evidence of a clinically unstable disease, as determined by medical history, clinical laboratory tests, and physical examination that, in the Investigator?s opinion, preclude entry into the study. “Clinically significant” is defined as any disease that, in the opinion of the Investigator, would put the subject at risk through study participation, or which would affect the outcome of the study 6. In the Investigator?s opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to the screening visit 7. Significant, non-reversible active pulmonary disease (e.g. cystic fibrosis, bronchiecstasis, tuberculosis) 8. Known Human Immunodeficiency Virus (HIV)-positive status 9. Current smoking history within 12 months prior to the screening visit 10. Current evidence of alcohol or substance abuse within 12 months prior to the screening visit 11. Subjects who have taken ß- blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, astemizole (Hismanal), quinidine type antiarrythmics, or potent CYP 3A4 inhibitors such as ketoconazole within 1 week prior to the screening visit 12. Current use of medications, other than those allowed in the protocol, that in the investigator?s opinion will have an effect on bronchospasm and/or pulmonary function 13. Current evidence of hypersensitivity or idiosyncratic reaction to test medications or components 14. Receipt of an Investigational medicinal product within 30 days of the screening visit 15. Current participation in a clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to show superiority in the efficacy of Flutiform pMDI 50/5µg (2 puffs bid) versus fluticasone pMDI 50 µg (2 puffs bid).;Secondary Objective: The key secondary objective is to show non-inferiority in the efficacy of Flutiform 50/5 µg (2 puffs bid) to Seretide 50/25 µg (2 puffs bid) Other secondary objectives of the study are to: Compare the safety of Flutiform to fluticasone Compare the safety of Flutiform to Seretide;Primary end point(s): Primary endpoint is the change from pre dose FEV1 at baseline to 2 hours post-dose FEV1 over the 12 week treatment period.;Timepoint(s) of evaluation of this end point: End of the 12 week treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints which will be tested in a hierarchical (gate keeping manner) for the two study comparisons (Flutiform to Fluticasone, then Flutiform to Seretide): • FEV1 AUC0-4 at Week 12 • Change in pre-dose FEV1 from baseline over the 12 week treatment period Other exploratory secondary endpoints will include: • Change from pre-dose FEV1 at baseline to 2-hours post-dose FEV1 at the end of the 12 week treatment period • Change from pre-dose FEV1 at baseline to the end of the 12 week treatment period • Change from pre-dose FEV1 at baseline to 2-hours post-dose FEV1 at Day 1 • FEV1 AUC0-4 at Day 1 • Change in morning and evening PEFR from baseline over the 12 week treatment period • Change from baseline for other lung function parameters over the 12 week treatment period. • Proportion of discontinuations due to lack of efficacy • Change in amount of rescue medication use from baseline (end of run-in) over the 12 week treatment period • Change in percentage of rescue medication free days from baseline (end of run-in) over the 12 week treatment period • Change in asthma symptom scores from baseline (end of run-in) over the 12 week treatment period • Change in percentage of asthma symptom free days from baseline (end of run-in) over the 12 week treatment period • Change in sleep disturbance scores from baseline (end of run-in) over the 12 week treatment period • Change in percentage of awakening free nights from baseline (end of run-in) over the 12 week treatment period • Change in percentage of asthma control days from baseline (end of run-in) over the 12 week treatment period • Incidence of treatment-emergent asthma exacerbations • Annualised rate of treatment-emergent asthma exacerbations • Amount of daily oral and parenteral corticosteroid use • Compliance with study medication • Mean change in paediatric asthma quality of life (PAQLQ-IA) from baseline to the end of the 12 week treatment period in all subjects • Proportion of patients | — |
Countries
Bulgaria, Czech Republic, Hungary, India, Poland, Romania, Russian Federation, Ukraine
Contacts
Public ContactFunctional Director of European Cli
Mundipharma Research Limited
Outcome results
None listed