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New triple inhaler aims to tame tough asthma

NCT ID NCT02676076

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new inhaler that combines three medicines (beclometasone, formoterol, and glycopyrronium) against a standard two-medicine inhaler in over 1,100 adults with asthma that was not well controlled. The goal was to see if the triple combination improves lung function and reduces asthma attacks over 52 weeks. The trial has been completed, and results are being analyzed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Triple-combination inhaler (beclometasone, formoterol, glycopyrronium)
What this could lead to
If successful, this triple inhaler could offer better lung function and fewer asthma attacks for people whose asthma is not controlled with standard two-drug inhalers.
What could go wrong
This is a completed Phase 3 trial, so results are available, but the benefit over existing treatments may be modest. Side effects from the extra drug are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,155 people

The number who actually took part.

Started

Feb 2016

Finished

May 2018

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * History of asthma ≥ 1 year and diagnosed before 40 years old * Uncontrolled asthma with double therapy only on medium 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 or ex-smokers (\>= 10 packs year) * Any change in dose, schedule or formulation of ICS + LABA combination in the 4 weeks prior screening

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Chiesi Clinical Trial Site 276814

    Rostock, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.