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VENTOLIN Mini-Spacer, Aerochamber Plus spacer · 1 trial · 1 indication
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...
VENTOLIN Mini-Spacer, Aerochamber Plus spacer is used for asthma. It is a spacer device studied in a Phase 1 clinical trial to assess systemic exposure of certain inhaled medications when given with the spacer. The trial enrolled 21 participants in the United Kingdom and has been completed.
VENTOLIN Mini-Spacer, Aerochamber Plus spacer is developed by GSK plc, which trades under the ticker GSK. The company conducted a Phase 1 clinical trial to evaluate the device in asthma patients.
VENTOLIN Mini-Spacer, Aerochamber Plus spacer is in Phase 1 clinical development. The single trial, NCT02045953, has been completed. The device is investigational and not approved for marketing based on the available data.
VENTOLIN Mini-Spacer, Aerochamber Plus spacer has one completed clinical trial, NCT02045953. The study assessed systemic exposure of FLIXOTIDE (fluticasone propionate) and SERETIDE (fluticasone propionate and salmeterol) given with the VENTOLIN Mini-Spacer compared to the Aerochamber Plus spacer. It enrolled 21 participants with asthma in the United Kingdom.
VENTOLIN Mini-Spacer, Aerochamber Plus spacer is a spacer device studied in comparison with the Aerochamber Plus spacer. The clinical trial NCT02045953 compared systemic exposure of medications given with the VENTOLIN Mini-Spacer versus the Aerochamber Plus spacer, indicating they are distinct devices.