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

Chiesi

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: CHF 1535 200/6 µg; Drug: CHF 5993 200/6/12.5 µg; Drug: CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02676089

2015-000717-40 (EudraCT Number)

CCD-05993AB2-02

Details and patient eligibility

About

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.

Enrollment: 1,433 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,433 participants in 3 patient groups

CHF 5993 200/6/12.5 µg

Experimental group

Description:

Treatment A: CHF 5993 200/6/12.5 µg: 2 inhalations bid Total daily dose: 800/24/50 µg BDP/FF/GB

Treatment:

Drug: CHF 5993 200/6/12.5 µg

CHF 1535 200/6 µg

Active Comparator group

Description:

Treatment B: CHF 1535 200/6 µg: 2 inhalations bid Total daily dose: 800/24 µg BDP/FF

Treatment:

Drug: CHF 1535 200/6 µg

CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg

Active Comparator group

Description:

Treatment C (open-label arm): CHF 1535 200/6 µg: 2 inhalations bid + Tiotropium Respimat 2.5 µg: 2 inhalations od Total daily dose: 800/24 µg BDP/FF + 5 µg Tio

Treatment:

Drug: CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg