Severe asthma

Asthma needing high-dose inhaled corticosteroids plus LABA (GINA step 4–5) or systemic steroids for control. Covers T2-high (eosinophilic) and T2-low phenotypes. Add-on therapy in GEMA 5.4 and GINA 2024: tiotropium, biologics (anti-IgE, anti-IL5, anti-IL4Rα).

ICD-10 J45.91 drug

Also known as: Severe persistent asthma, Uncontrolled asthma on high steps

Drugs used for this condition

ATiotropiumAdd-on therapy · Long-acting muscarinic antagonist for inhalation (LAMA)Tiotropium Respimat is add-on therapy for severe asthma in adults and adolescents from age 6 when ICS+LABA fail to achieve control. GINA 2024 positions tiotropium at steps 4–5 as an option before biologics. EMA approved tiotropium Respimat for asthma in adults in 2014 and in children from age 6 in 2017. Marketing of tiotropium in mild asthma or in children under 6 is off-label without RCT support.

How to read tiers A–F

Evidence tiers belong to the drug-indication pair, not to the drug as a whole: the same substance can be A for one condition and F for another.

AStrong evidence – first or second line in international guidelines
BRecommended in selected cases
CStudy data contradict each other
DBenefit not proven, no documented harm
FDocumented harm, or risk without benefit