CompletedPhase 3

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

Argentina, Belarus, Bulgaria1,437 participantsStarted 2016-04-06

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial compared a triple inhaler combining three medications against a two-drug ICS/LABA inhaler plus a separate tiotropium inhaler — could you help me understand whether combining all three drugs in one device would actually make a difference in how I manage my asthma day-to-day?
2The trial ran for 52 weeks and measured how often participants had moderate or severe asthma attacks — based on what the results showed, do you think a triple-therapy approach could be worth considering for someone with my level of asthma severity?
3Since this was a Phase 3 trial, it was designed to confirm effectiveness in a larger group of people — does the fact that it's now completed mean there's enough evidence from this research to inform my treatment options, or is it still too early to draw conclusions?
4The trial also measured lung function using FEV1 at 26 weeks — how much improvement in that kind of breathing test would actually be meaningful for someone in my situation, and is that a realistic goal with triple therapy?
5Before considering whether a triple inhaler might be right for me, is there a standard two-drug inhaler regimen I should try first, or does my current asthma control suggest I might benefit from jumping straight to a three-medication approach?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

1_Change From Baseline in Pre-Dose Forced Expiratory Volume in the First Second (FEV1) at Week 26

Timeframe: Week 0 (pre-treatment, baseline) to Week 26.

2_Moderate and Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period

Timeframe: Week 0 (pre-treatment, baseline) to Week 52.

Trial details

NCT IDNCT02676089

SponsorChiesi Farmaceutici S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-05-28

Results submitted2026-02-12

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