Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified Health Condition 2: J459- Other and unspecified asthma
Conditions
Interventions
Intervention1: Placebo Ciphaler™: Inhaled route
Control Intervention1: Rotahaler® with Placebo Rotacaps: Inhaled Route
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Voluntarily given signed dated Informed consent from subjects. 2. Subjects of 18 years and above with history of asthma or COPD for more than 6 months prior to screening. 3. Subjects with asthma or COPD who are device naïve or those using BAI, pMDI or pMDI + spacer. 4. Subjects naïve to Ciphaler™ and Rotahaler® use. 5. Subjects naïve to any other DPIs for 6 months prior to screening. 6. Subjects able to read PIL.
Exclusion criteria
Exclusion criteria: 1. Subjects who are hypersensitive to placebo or its constituents. 2. Subjects with any condition that affected the subject’s ability to operate the inhaler such as cognitive or musculoskeletal or neurological conditions (myopathy or neuropathy causing muscle weakness of the upper limbs, tracheostomy and impaired mental status, rheumatism, eye disorder, dementia, and finger disorder or injury). 3. Subjects ineligible to use a DPI in Investigator’s opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time taken to use the device correctly Proportion of subjects who made errors after reading the PIL Proportion of subjects who made errors after training Average number of errors made by the patient Total number of training sessions Number of attempts Assessment of self-completed device usability questionnaire (Part A and B)Timepoint: Single Visit | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactMr Abhijit Vaidya
Cipla Limited
Outcome results
None listed