Health Condition 1: - Health Condition 2: J449- Chronic obstructive pulmonary disease, unspecified Health Condition 3: J398- Other specified diseases of upperrespiratory tract
Conditions
Interventions
Intervention1: Placebo Capsules: In one day study, 02 placebo capsules will be provided for each patient for their trained and untrained sessions during final demonstration of inhalation technique and
Sponsors
Cipla Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1)Male and female adult subjects of any ethnic origin, aged 40 years and above. 2)Subjects willing to provide signed and dated written informed consent voluntarily. 3)Subjects who can read, understand and converse in English. 4)Subjects with stable COPD based on investigatorâ??s discretion. 5)Subjects who have not taken part in any market research or a clinical trial related to a pharmaceutical product or a medical device in the past one month. 6)Subjects who can use the inhaler independently.
Exclusion criteria
Exclusion criteria: 1) Subjects with co-ordination problems like Parkinsonâ??s disease, mental illness, tremors etc. 2) Subjects having medical history of intolerance to milk and other dairy products, and/or confirmed physician diagnosis of lactose intolerance. 3) Subjects who are judged suspicious by the investigator for coronavirus disease 2019 (COVID-19) based on the screening questionnaire for COVID-19.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Total number of tasks (steps) during scenario 1 and scenario 2 task performance assessments recorded using handling assessment checklist. 2. Ease of use and satisfaction assessment analysed from the device handling questionnaire Timepoint: Subjects who complete both the use scenarios will be considered to have completed the study and will be termed as evaluable population (i.e. primary population) for data compilation during 1 or 2 days study duration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicableTimepoint: Not applicable | — |
Countries
India
Contacts
Public ContactDr Piyush Agarwal
Director, Clinical & Medical operation
Outcome results
None listed