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Asthma inhaler switch may help patients breathe easier, study finds

NCT ID NCT05168995

Disease control Sponsor: Chiesi Italia Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This study looked at 620 adults with asthma that was not well controlled on their current treatment. They were given a combination inhaler (beclometasone/formoterol) to use daily. After 6 months, researchers measured how many patients improved their asthma control using a standard questionnaire. The goal was to see if this inhaler works well in everyday, real-world settings.

What this could mean

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

Active substance
beclometasone dipropionate/formoterol fumarate (BDP/FF) inhaler
What this could lead to
If successful, this could show that switching to this inhaler helps more people with asthma gain better day-to-day control of their symptoms.
What could go wrong
This is a real-world study without a comparison group, so improvements may be due to other factors. Results may not apply to all asthma patients.

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.

Participants

620 people

The number who actually took part.

Started

Apr 2022

Finished

Feb 2024

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.

Who is studied

Not adequately controlled asthmatic adult patients (according to clinician's judgement)

Ages

18 years and older

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: 1. Male or female patients aged ≥18 years; 2. Patients enrolled on the same day as the first prescription with BDP/FF NEXThaler® 100/6 micrograms, or having ongoing treatment with BDP/FF NEXThaler® 100/6 micrograms started within the previous 14 days (maximum), as per local standard clinical practice. 3. Not adequately controlled asthmatic patients (according to clinician's judgement) when BDP/FF NEXThaler® 100/6 micrograms was prescribed; 4. Patients not treated with extrafine formulations during the 6 months before starting the treatment with BDP/FF NEXThaler®; 5. Written informed consent to participate in the study and for the processing of personal data. Exclusion Criteria: 1. Recent (i.e. within the last 6 months) history of life-threatening asthma exacerbations; 2. Diagnosis of chronic obstructive pulmonary disease (COPD); 3. Asthmatic patients on treatment with biologic agents (e.g. monoclonal antibodies) and/or extemporary or fixed triple combinations (e.g. long-acting β2 agonist (LABA)/long-acting muscarinic antagonist (LAMA)/inhaled corticosteroid (ICS) at any dose regimen; 4. Patients with uncontrolled/clinically significant diseases (according to clinician's judgement) or inability to understand and fill in study questionnaires; 5. Concomitant participation in experimental clinical studies/investigations or participation in experimental clinical studies/investigations within 3 months prior to enrolment into the present study.

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

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

Asthma

Contacts and locations

Locations

  • Ospedale dell'Angelo

    Mestre, VE, Italy

More trials for these conditions

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