Clinical Trials Detalhe
TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER)
Visão Geral
Gender
ALL
Idade
from 18 Years to 75 Years
Fase
PHASE3
Tipo de Estudo
INTERVENTIONAL
Localização
Chiesi Clinical Trial Site 620704 (Aveiro, Portugal)
Chiesi Clinical Trial Site 620703 (Figueira da Foz Municipality, Portugal)
Chiesi Clinical Trial Site 620702 (Lisbon, Portugal)
Chiesi Clinical Trial Site 620708 (Loures, Portugal)
Chiesi Clinical Trial Site 620707 (Vila Nova de Gaia, Portugal)
Clinicaltrial.gov
https://classic.clinicaltrials.gov/ct2/show/NCT02676089Sumário
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.
Condições
Asthma
Elegibilidade
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