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

• Status: Completed
• Trial end date: 2018-05-17
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Beclomethasone; Formoterol Fumarate

Criteria

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