TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA (TRIMARAN)

Chiesi

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: CHF 5993 100/6/12.5 µg; Drug: CHF 1535 100/6 µg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02676076

CCD-05993AB1-03

2015-000716-18 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the superiority of CHF 5993 100/6/12.5 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronum bromide) versus CHF 1535 100/6 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate), in terms of lung functions parameters and rate of exacerbations, as well as to assess its safety and some health economics outcomes.

Enrollment: 1,153 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 medium 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 or ex-smokers (>= 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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1,153 participants in 2 patient groups

CHF 5993 100/6/12.5 µg

Experimental group

Description:

Treatment A: CHF 5993 100/6/12.5 µg: 2 inhalations bid Total daily dose: 400/24/50 µg BDP/FF/GB

Treatment:

Drug: CHF 5993 100/6/12.5 µg

CHF 1535 100/6 µg

Active Comparator group

Description:

Treatment B : CHF 1535 100/6 µg: 2 inhalations bid Total daily dose: 400/24 µg BDP/FF

Treatment:

Drug: CHF 1535 100/6 µg