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

Phase 3

Completed

• Conditions: Asthma
• Interventions: 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

• Registration Number: NCT02676089
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-08
• Study Start: 2016-04-06
• Primary Completion: 2018-05-28
• Study Completion: 2018-05-28
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1433

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHF 1535 200/6 µg	CHF 1535 200/6 µg	Treatment B: CHF 1535 200/6 µg: 2 inhalations bid Total daily dose: 800/24 µg BDP/FF
CHF 5993 200/6/12.5 µg	CHF 5993 200/6/12.5 µg	Treatment A: CHF 5993 200/6/12.5 µg: 2 inhalations bid Total daily dose: 800/24/50 µg BDP/FF/GB
CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg	CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg	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

Primary Outcome Measures

Name	Time	Method
Reduction of moderate and severe asthma exacerbations rate	Week 0 to Week 52
Pre-dose FEV1 (Forced Expiratory Volume in the first second)	Week 26

Secondary Outcome Measures

Name	Time	Method
Peak FEV1 (Peak of Forced Expiratory Volume in the first second) within 3 hours post-dose	Week 26
Reduction of severe asthma exacerbations rate	Week 0 to week 52	Pooled analysis of CCD-05993AB1-03 and CCD-05993AB2-02 trials
Change from baseline in morning PEF (Peak Expiratory Flow)	Week 0 to Week 26

Trial Locations

Locations (244)

Chiesi Clinical Trial Site 432704; 🇦🇷 Caba, Argentina

Chiesi Clinical Trial Site 432702; 🇦🇷 Ciudad Autónoma de Buenos Aires, Argentina

Chiesi Clinical Trial Site 432705; 🇦🇷 Mar Del Plata, Argentina

Chiesi Clinical Trial Site 432701; 🇦🇷 Quilmes, Argentina

Chiesi Clinical Trial Site 432703; 🇦🇷 San Miguel de Tucumán, Argentina

Chiesi Clinical Trial Site 432706; 🇦🇷 Tucuman, Argentina

Chiesi Clinical Trial Site 112703; 🇧🇾 Gomel, Belarus

Chiesi Clinical Trial Site 112704; 🇧🇾 Gomel, Belarus

Chiesi Clinical Trial Site 112701; 🇧🇾 Minsk, Belarus

Chiesi Clinical Trial Site 112702; 🇧🇾 Minsk, Belarus

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