Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02045953 | A Study to Assess the Systemic Exposure of FLIXOTIDE™ (Fluticasone Propionate) and SERETIDE™ (Fluticasone Propionate and Salmeterol) Given With VENTOLIN™ Mini-Spacer Compared to the Aerochamber Plus Spacer | PHASE1 | COMPLETED | 21 | — | — | Jan 29, 2014 | Mar 13, 2014 | Jun 19, 2018 | 1 | United Kingdom |
Blood samples will be collected for pharmacokinetic analysis of Fluticasone propionate at the time points indicated
Blood samples will be collected for pharmacokinetic analysis of Salmeterol at the time points indicated
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Participant will receive study treatments in following sequence in four treatment periods (one treatment per period): ABCD, where A= FLIXOTIDE 250 Hydrofluoroalkane (HFA) with Aerochamber Plus spacer, B= FLIXOTIDE 250 HFA with VENTOLIN Mini-Spacer, C= SERETIDE 250/25 HFA with Aerochamber Plus spacer, D= SERETIDE 250/25 HFA with VENTOLIN Mini-Spacer |
| Sequence 2 | EXPERIMENTAL | Participant will receive study treatments in following sequence in four treatment periods (one treatment per period): BDAC, where A= FLIXOTIDE 250 HFA with Aerochamber Plus spacer, B= FLIXOTIDE 250 HFA with VENTOLIN Mini-Spacer, C= SERETIDE 250/25 HFA with Aerochamber Plus spacer, D= SERETIDE 250/25 HFA with VENTOLIN Mini-Spacer |
| Sequence 3 | EXPERIMENTAL | Participant will receive study treatments in following sequence in four treatment periods (one treatment per period): CADB, where A= FLIXOTIDE 250 HFA with Aerochamber Plus spacer, B= FLIXOTIDE 250 HFA with VENTOLIN Mini-Spacer, C= SERETIDE 250/25 HFA with Aerochamber Plus spacer, D= SERETIDE 250/25 HFA with VENTOLIN Mini-Spacer |
| Sequence 4 | EXPERIMENTAL | Participant will receive study treatments in following sequence in four treatment periods (one treatment per period): DCBA, where A= FLIXOTIDE 250 HFA with Aerochamber Plus spacer, B= FLIXOTIDE 250 HFA with VENTOLIN Mini-Spacer, C= SERETIDE 250/25 HFA with Aerochamber Plus spacer, D= SERETIDE 250/25 HFA with VENTOLIN Mini-Spacer |
| Name | Type | Description |
|---|---|---|
| VENTOLIN Mini-Spacer | DEVICE | VENTOLIN mini-spacer will be used to dispense the SERETIDE Evohaler and FLIXOTIDE Evohaler |
| Aerochamber Plus spacer | DEVICE | Aerochamber Plus spacer will be used to dispense the SERETIDE Evohaler and FLIXOTIDE Evohaler |
Inclusion Criteria: * Male or female subjects between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests an...