Study type

Study type

Non-interventional study
Non-interventional study

Non-interventional study design

Cohort
Cross-sectional
Study drug and medical condition

Medical condition to be studied

Asthma
Chronic obstructive pulmonary disease
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

204
Study design details

Main study objective

To measure the time needed and number of attempts for patients with asthma and COPD to master the required inhaler technique for a specific delivery device available as part of their normal care.

Outcomes

Time taken to achieve device mastery (as recorded in seconds from the beginning of training) and number of attempts to reach device mastery (please see full protocol for details). After training and assessment on the devices, the patient will complete an inhaler device preference questionnaire developed by OPC and administered by the HCPs and/or service coordinator on the day of the iHARP asthma/COPD review clinic (please see full protocol for details).

Data analysis plan

Statistically significant results will be defined as p<0.05 and trends as 0.05≤p<0.10. Summary statistics will be produced for all baseline and outcome variables, as a complete dataset and by inhaler device. The mean/median time required to achieve device mastery will be compared by using Cox regression analysis. Log-rank tests will be carried out and p-values reported. The mean/median number of attempts required to achieve device mastery will be compared by using a paired t-test (means) or Wilcoxon signed rank test (medians), dependent on the data distribution. Results from the patient preference questionnaire will be compared using a paired t-test or wilcoxon signed rank test depending on the data distribution. The 5% level of significance will be used (two-tailed test).