Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Effectiveness study (incl. comparative)

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Non-interventional, observational study based on new data collection
Study drug and medical condition

Medical condition to be studied

Asthma
Population studied

Short description of the study population

Patients aged ≥ 15 years old with severe persistent asthma who were naive to Spiriva respimat and receive Spiriva Respimat for the first time for the treatment of bronchial asthma on top of at least ICS treatment where safety of Spiriva® 2.5 µg Respimat® 60 puffs under the real-world use was not confirmed in clinical trials.

Age groups

Adolescents (12 to < 18 years)
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)

Special population of interest

Other

Special population of interest, other

Asthma patients

Estimated number of subjects

360
Study design details

Main study objective

To investigate the safety and effectiveness of Spiriva Respimat in patients with asthma under the real-world use.

Outcomes

The primary Outcome is the absolute and relative (%) frequency of patients with suspected adverse drug reactions (ADRs). Change from baseline in asthma control status

Data analysis plan

To be analysed only descriptively