Overview

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

Status:
Completed
Trial end date:
2018-05-28
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Treatments:
Beclomethasone
Formoterol Fumarate
Tiotropium Bromide
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