Health Condition 1: null- Asthma
Conditions
Interventions
Intervention1: pMDI Flutiform® - Fluticasone Propionate/ Formoterol Fumarate: Dosage form- 2 puffs
Unit strength- 50/5 microgram
Dosing Frequency: Q12h
Mode of Administration: Inhaled with Spacer
Tot
Sponsors
Mundipharma Research Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and Female subjects 5 to less than 12 years old. 2. Known history of moderate to severe persistent reversible asthma for greater than or equal to 6 months prior to the screening visit. 3. Demonstrated FEV1 of greater than or equal to 60 percent to less than or equal to 90 percent for predicted normal values (Polgar 1971) during the screening period following appropriate withholding of asthma medications (if applicable): a) No LABA use within 12 hours and/or no SABA use within 6 hours of the PFT b) No use of inhaled ICS-LABA asthma therapy within 12 hours of the PFT c) Inhaled corticosteroids are allowed on the day of screening 4. Documented reversibility of greater than or equal to 15 percent in FEV1 in the screening period 5. Current use of an inhaled corticosteroid for asthma at a stable dose for at least 4 weeks prior to the screening visit 6. Inadequate asthma control on an ICS alone at a dose of less than or equal to 500 microgram fluticasone equivalents/day, OR controlled asthma on an ICS-LABA combination at a ICS dose of less than or equal to 200 microgram fluticasone equivalents/day 7. Demonstrated satisfactory technique in the use of the pMDI and spacer device 8. Can perform spirometry adequately 9. Willing and able to enter information in the electronic diary with the help of a parent or guardian, if necessary and attend all study visits 10. Willing and able to substitute pre-study prescribed inhaled asthma medication for the entire duration of the study 11. If a female subject is post menarche a urine pregnancy test may be undertaken at the discretion of the investigator and the subjects parent(s) /legal representative. This test must be negative. 12. Written informed consent and assent obtained as per national laws
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. â??Clinically significantâ?? 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 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 Beta- 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 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. Other Criteria Randomisation criteria required following run-in 1. Demonstrated FEV1 to less than or equal to 90 percent for predicted normal values during Visit 3 following appropriate withholding of study medication a) No salbutamol use within 6 hours of the PFT b) No fluticasone use on the day of Visit 3 2. During the last 7 days of the run-in period subject has used rescue medication for at least 3 days and, a) had at least one night with sleep disturbance (i.e. sleep disturbance score of greater than equal to 1) during the last 7 days of the run in period, and/or b) had at least 3 days with asthma symptoms (i.e. a symptom score of greater than or equal to 1) during the last 7 days of the run-in period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the change in pre-morning dose FEV1 values from baseline to the 2-hour post dose FEV1 values at the end of the 12 week treatment period.Timepoint: At week 12 from baseline to end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoints (for the primary comparison of Flutiform to fluticasone) , 1. FEV1 AUC0-4 at Week 12 2. Change in pre-dose FEV1 from baseline to the end of the 12 week treatment period Key endpoint for the secondary, exploratory comparison (Flutiform to Seretide) 3. Change from pre-dose FEV1 at baseline to 2 hours post-dose FEV1 at Day 1Timepoint: At week 12 and from baseline to end of treatment period | — |
Countries
Bulgaria, Czech Republic, Hungary, India, Poland, Romania, Russian Federation, Ukraine
Contacts
Public ContactDr Mamta Singh
Kendle India Pvt. Ltd.
Outcome results
None listed