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