None listed
Conditions
Interventions
Intervention1: Novel Inhaler Device: Inhaler device with placebo cartridges.
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 A written, signed and dated informed consent from all participants/ legally acceptable representatives will be obtained before start of study procedures, 2 Healthy volunteers (having no significant major organ disease) 3 Either gender with age between 30 and 65 years (both inclusive).
Exclusion criteria
Exclusion criteria: 1. Previous experience or current use of any inhaler device 2. History of asthma or COPD or diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average time taken for three consecutive correct attempts during the first and second visit.Timepoint: Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Device rating scoreTimepoint: At 2nd visit;Number of errors during both visitsTimepoint: Throughout the study;Number of training sessions and attempts required to perform the inhalation technique correctly during the first and second visitTimepoint: Throughout the study;Percentage of participants who use the novel inhaler device without errors and without retraining at 2nd visitTimepoint: At 2nd visit;Types of errors.Timepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactMr Rahul Namjoshi
Cipla Ltd.
Outcome results
None listed