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Asthma treatment showdown: higher dose or triple therapy?

NCT ID NCT05919394

Disease control Sponsor: Galaxia Empírica 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study aimed to compare two treatment options for adults with T2-high asthma that remains uncontrolled despite medium-dose inhaled steroids and long-acting beta agonists. One group would receive a higher dose of the same combination, while the other would add a third medication (a long-acting muscarinic antagonist). The goal was to see which strategy led to better asthma control after one year. However, the study was withdrawn before any participants were enrolled.

What this could mean

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

Active substance
inhaled corticosteroid and long-acting beta agonist (ICS/LABA) with or without a long-acting muscarinic antagonist (LAMA)
What this could lead to
If completed, this could help identify the best treatment step for people with T2-high asthma that is not well controlled.
What could go wrong
The study was withdrawn before enrolling anyone, so no results are available. It was a real-world study, not a tightly controlled trial, which can make findings less certain.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Started

Jun 2023

Finished

Nov 2024

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Ages

18 to 80 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: * Patients between 18 and 80 years of age diagnosed of uncontrolled asthma. * T2 high asthma: \> 300 cels/mm3 blood Eos (current value) or 150 cels/mm3 blood Eos (current value) and a historical value ≥ 300 cels/mm3 or FENO ≥ 25 ppb (current value). * Uncontrolled asthma, this is, ACT \<20 and/or \> 1 of an exacerbation in the last 12 months, despite treatment with ICS/LABA at medium dose. * Written informed consent. Exclusion Criteria: * Patients who refuse to sign the informed consent form. * Medical situation that prevents the collection of study information. * Diagnosis of severe uncontrolled asthma established with criteria other than those established (ACT \<20 and/or \> 1 exacerbation in the last 12 months, despite treatment with ICS / LABA at medium dose). * Medical or administrative situation that prevents the patient from following up to a minimum of 52 weeks. * Treatment with high dose ICS/LABA, LAMA, systemic corticosteroid, azithromycin, monoclonal antibody.

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Conditions

The condition(s) this trial relates to.

asthma Cough Dyspnea Respiratory Sounds

As listed by the trial registrant

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

Asthma

Contacts and locations

Locations

  • Hospital Clínico Universitario de Salamanca

    Salamanca, Salamanca, 37007, Spain

  • Hospital Comarcal de Inca - Tramuntana

    Inca, Balearic Islands, 07300, Spain

  • Hospital Costa del Sol

    Marbella, Álaga, 29603, Spain

  • Hospital General Universitario Dr. Balmis de Alicante

    Alicante, Alicante, 03010, Spain

  • Hospital Universitario Clínico San Cecilio

    Granada, Granada, 18016, Spain

  • Hospital Universitario De Jerez

    Jerez de la Frontera, Cádiz, 11407, Spain

  • Hospital Universitario Doctor Peset

    Valencia, Valencia, 46017, Spain

  • Hospital Universitario Galdakao-Usansolo

    Galdakao, Bizkaia, 48960, Spain

  • Hospital Universitario Lucus Augusti

    Lugo, Lugo, 27003, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, 28034, Spain

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07120, Spain

  • Hospital Universitario Virgen de las Nieves

    Granada, Granada, 18014, Spain

  • Hospital Universitario de A Coruña

    A Coruña, A Coruña, 15006, Spain

  • Hospital Universitario de Cruces

    Barakaldo, Bizkaia, 48903, Spain

  • Hospital Universitario de Navarra

    Pamplona, Navarre, 31008, Spain

  • Hospital de Sagunto

    Sagunto, Valencia, 46520, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08025, Spain

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