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

NCT02676089 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1437

Last updated 2026-05-29

Study results available
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Summary

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.

Conditions

Interventions

DRUG

CHF 5993 200/6/12.5 µg

DRUG

CHF 1535 200/6 µg

DRUG

CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Georgio Walter Canonica, MD · University of Medicine, Genoa, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-06
Primary Completion
2018-05-28
Completion
2018-05-28

Countries

  • Argentina
  • Belarus
  • Bulgaria
  • Czechia
  • Germany
  • Hungary
  • Italy
  • Lithuania
  • Poland
  • Portugal
  • Romania
  • Russia
  • Slovakia
  • Spain
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02676089 on ClinicalTrials.gov