TABLE 11

Products, inhalers, and characteristics of ICS-LABA-LAMA combination therapies

Prescribing Information: www.accessdata.fda.gov/scripts/cder/daf/ (USA), www.fachinfo.de/(EU, Germany), www.medicines.org.uk/emc/(UK).

Active IngredientIndication (Brand)aInhalerDelivered DosePharmacological ProfileClinical Summary
Budesonide + glycopyrronium (bromide)
+formoterol (fumarate dihydrate)
Maintenance treatment of COPD (not in asthma) (USA)
Bretztri Aerosphere
pMDI160 μg (bud) +, 9 μg (gly-br) + 4.8 μg (for-
fu-hydr)/puff2 puffs BID
LAMA LABA
and ICS
Improvement of airflow vs. LABA-ICS, improvement of HRQob vs. LABA-ICS and LABA-LAMA, reduction of exacerbationsc vs. LABA- ICS and LABA-LAMA (1 of 2 studies)
Fluticasone furoate + umeclidinium (bromide) + vilanterol (trifenatate)Maintenance treatment of COPD
Trelegy (Elebrato) Ellipta
Multidose DPI (strip package)92 μg (flu-fu) + 55 μg (ume) + 22 μg (vil)
1 inhalation QD
LAMA LABA
and ICS
Improvement of airflow vs. LABA-ICS, improvement of symptomsd vs. LABA-ICS and LABA-LAMA,
improvement of HRQoLb vs. LABA-ICS (1 of 2
studies)
Beclomethasone (diproprionate)+ glycopyrronium (bromide) + formoterol (fumarate dihydrate)Maintenance treatment of COPD
Trimbow (EU)
pMDI87 or 172 µg (bec-pro) + 11 μg (gly-bro) + 6 μg (for-fu-hydr)/puff
2 puffs BID
LAMA LABA
and ICS, extrafine aerosol
Improvement of airflow and dyspneae vs. LABA-ICS, improvement of HRQob and reduction of exacerbationsc vs. LABA- ICS and LABA-LAMA
Mometasone (fuorate) +
glycopyrronium
(bromide)+
indacaterol (acetate)
Maintenance treatment of asthma (age ≥ 18 y) Enerzair Breezhaler (EU)Single dose DPI136 µg (mom-fu) + 58 µg (gly-br) + 114 µg (ind)
1 inhalation QD
LAMA LABA
and ICS
Prevention of symptoms and exacerbations in patients not sufficiently controlled with LABA and high dose ICS. Improvement of airflow and reduction of exacerbationsc vs. LABA-ICS (1 of two
studies)
  • aThe brand names are not meant to be an exhaustive list; they are provided for illustrative purposes as different products containing the same drugs may have different quantitative compositions, formulations devices and overall characteristics.

  • bAssessed by St. Georges Respiratory Questionnaire (SGRQ).

  • cModerate + severe exacerbations.

  • dCOPD assessment test (CAT)-Score.