TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER)

Study Identifier:
CCD-05993AB2-02
ClinicalTrials.gov Identifier:
NCT02676089
EudraCT Identifier:
2015-000717-40
EU CT ID:
N/A
Study Contact Information:
N/A
See Study Publication Below
Study Complete

Trial Documents

Clinical Study Report
Available Languages: English
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Study Details

Medical Condition
  • Asthma
Study Drug
  • Drug: CHF 5993 200/6/12.5 µg
  • Drug: CHF 1535 200/6 µg
  • Drug: CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg
Date
Apr 2016 - May 2018
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 75 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • History of asthma ≥ 1 year and diagnosed before 40 years old
  • Uncontrolled asthma with double therapy only on high doses of Inhaled CorticoSteroid (ICS) in combination with Long-Acting Beta2 Agonist (LABA) with ACQ-7 (Asthma Control Questionnaire) ≥1.5
  • Pre-bronchodilator FEV1 \<80% of the predicted normal value
  • Positive reversibility test
  • At least 1 documented asthma exacerbation in the previous year
Exclusion Criteria
  • Pregnant or lactating women
  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
  • Patients with any asthma exacerbation or respiratory tract infection in the 4 weeks prior screening
  • Current smoker or ex-smoker (\>= 10 packs year)
  • Any change in dose, schedule or formulation of ICS + LABA combination in the 4 weeks prior screening
Healthy Volunteers
No

Protocol Summary

The purpose of this study is to evaluate the superiority of CHF 5993 200/6/12.5 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) versus CHF 1535 200/6 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate) and to compare the effect of CHF 5993 200/6/12.5 µg pMDI vs CHF 5993 200/6/12.5 µg plus open-label Tiotropium 2.5µg, in terms of lung functions parameters and rate of exacerbations, as well as to assess its safety and some health economics outcomes.

Study Locations

Location
Status
Location
Chiesi Clinical Trial Site 432702
Buenos Aires, Argentina
Status
N/A
Location
Chiesi Clinical Trial Site 432704
CABA, Argentina
Status
N/A
Location
Chiesi Clinical Trial Site 432705
Mar del Plata, Argentina
Status
N/A
Location
Chiesi Clinical Trial Site 432701
Quilmes, Argentina
Status
N/A
Location
Chiesi Clinical Trial Site 432703
San Miguel de Tucumán, Argentina
Status
N/A
Location
Chiesi Clinical Trial Site 432706
San Miguel de Tucumán, Argentina
Status
N/A
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Study Publications

Virchow JC, Kuna P, Paggiaro P, Papi A, Singh D, Corre S, Zuccaro F, Vele A, Kots M, Georges G, Petruzzelli S, Canonica GW. Single inhaler extrafine triple therapy in uncontrolled asthma (TRIMARAN and TRIGGER): two double-blind, parallel-group, randomised, controlled phase 3 trials. Lancet. 2019 Nov 9;394(10210):1737-1749. doi: 10.1016/S0140-6736(19)32215-9. Epub 2019 Sep 30.Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.Orlovic M, Magni T, Lukyanov V, Guerra I, Madoni A. Cost-effectiveness of single-inhaler extrafine beclometasone dipropionate/formoterol fumarate/glycopyrronium in patients with uncontrolled asthma in England. Respir Med. 2022 Sep;201:106934. doi: 10.1016/j.rmed.2022.106934. Epub 2022 Jul 19.Papi A, Singh D, Virchow JC, Canonica GW, Vele A, Georges G. Normalisation of airflow limitation in asthma: Post-hoc analyses of TRIMARAN and TRIGGER. Clin Transl Allergy. 2022 Apr 17;12(4):e12145. doi: 10.1002/clt2.12145. eCollection 2022 Apr.Singh D, Virchow JC, Canonica GW, Vele A, Kots M, Georges G, Papi A. Determinants of response to inhaled extrafine triple therapy in asthma: analyses of TRIMARAN and TRIGGER. Respir Res. 2020 Oct 29;21(1):285. doi: 10.1186/s12931-020-01558-y.Singh D, Virchow JC, Canonica GW, Vele A, Kots M, Georges G, Papi A. Extrafine triple therapy in patients with asthma and persistent airflow limitation. Eur Respir J. 2020 Sep 24;56(3):2000476. doi: 10.1183/13993003.00476-2020. Print 2020 Sep. No abstract available.