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

NCT02676089

CompletedPhase 3

Sponsor: Chiesi Farmaceutici S.p.A.

Conditions: Asthma

Interventions: CHF 5993 200/6/12.5 µg, CHF 1535 200/6 µg, CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg

Countries: Argentina, Belarus, Bulgaria, Czechia, Germany, Hungary, Italy, Lithuania

Evaluate the superiority of CHF 5993 200/6/12.5 µg pressurised metered dose inhaler (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) in patients with uncontrolled asthma under medium doses of inhaled corticosteroid/long-acting β2-adrenergic receptor agonists (ICS/LABA), in patients with uncontrolled asthma who received medium doses of ICS/LABA. The treatments tested the improvement of the forced expiratory volume in the 1st second (FEV1) and the reduction of moderate and severe asthma exacerbations rate.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (244)
  • Buenos Aires, Argentina
  • CABA, Argentina
  • Mar del Plata, Argentina
  • Quilmes, Argentina
  • San Miguel de Tucumán, Argentina
  • San Miguel de Tucumán, Argentina
  • Homyel, Belarus
  • Homyel, Belarus
  • Minsk, Belarus
  • Minsk, Belarus
  • Minsk, Belarus
  • Blagoevgrad, Bulgaria
  • Burgas, Bulgaria
  • Gabrovo, Bulgaria
  • Haskovo, Bulgaria
  • Montana, Bulgaria
  • Pleven, Bulgaria
  • Plovdiv, Bulgaria
  • Plovdiv, Bulgaria
  • Plovdiv, Bulgaria
  • Rousse, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Stara Zagora, Bulgaria
  • Stara Zagora, Bulgaria
  • Varna, Bulgaria
  • Vidin, Bulgaria
  • + 214 more on CT.gov