AsthmaPhase 4TRICORDANCT05919394

Triple vs High Dose Inhaled CORticosteroids

A Phase 4 study of Asthma, run by Galaxia Empírica at 17 sites in Spain.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

Increase in inhaled corticosteroid dose vs triple therapy in T2-high asthma patients who remain uncontrolled with medium dose inhaled corticosteroids/long-acting β2 adrenergic combination: a real-life study. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Asthma
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 17 sitesSpain
Study dates: 1 Jun 2023to 14 Nov 2024
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

Spain17 sites

Hospital Universitario de A Coruña
A Coruña, A Coruña, 15006
Hospital General Universitario Dr. Balmis de Alicante
Alicante, Alicante, 03010
Hospital Universitario de Cruces
Barakaldo, Bizkaia, 48903
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Hospital Universitario Galdakao-Usansolo
Galdakao, Bizkaia, 48960
Hospital Universitario Virgen de las Nieves
Granada, Granada, 18014
Hospital Universitario Clínico San Cecilio
Granada, Granada, 18016
Hospital Comarcal de Inca - Tramuntana
Inca, Balearic Islands, 07300
Hospital Universitario De Jerez
Jerez de la Frontera, Cádiz, 11407
Hospital Universitario Lucus Augusti
Lugo, Lugo, 27003
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
Hospital Costa del Sol
Marbella, Álaga, 29603
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07120
Hospital Universitario de Navarra
Pamplona, Navarre, 31008
Hospital de Sagunto
Sagunto, Valencia, 46520
Hospital Clínico Universitario de Salamanca
Salamanca, Salamanca, 37007
Hospital Universitario Doctor Peset
Valencia, Valencia, 46017

Other trials in Spain

About this study

Official title: Increase in Inhaled Corticosteroid Dose vs Triple Therapy in T2-high Asthma Patients Who Remain Uncontrolled With Medium Dose Inhaled Corticosteroids/Long-acting β2 Adrenergic Combination: a Real-life Study. TRICORDA Study

Read the detailed description

It remains to be clarified whether triple therapy is better than high dose inhaled corticosteroids and long-acting beta2-agonists combination (ICS/LABA) in patients with uncontrolled asthma despite the use of medium dose ICS/LABA combinations, particularly in cases with high T2 biomarkers´ values. The aim of this study is to evaluate, in a real-world setting, which is the best therapeutic strategy in this clinical scenario.

This study will be a randomized, open-label, two-arm, prospective, 12-month trial to be conducted in 53 hospital asthma units. Participants will be allocated to receive one of two therapeutic strategies: same ICS/LABA combination at highest doses or the same maintenance therapy plus a long-acting anticholinergic (LAMA). Follow up visits will be scheduled at 12-16, 24-28 and 52 weeks after the baseline visit. The investigators can optimise therapy according to their clinical opinion if the patient remains uncontrolled. Demographic, clinical and lung function information will be collected at each visit.

The primary endpoint will be the percentage of patients controlled at week 52, with both an ACT score of 20 or greater and no severe exacerbations). 620 patients (282 patients per treatment group, considering 10% drop-out) will be required for the study to have 80% power to detect non-inferiority limit of 10% in the rate of controlled patients between the high dose ICS/LABA arm and the triple therapy arm. All effectiveness analyses will be done according to the intention-to-treat principle. Secondary endpoints: percentage of patients controlled at week 24, ACT at weeks 12, 24 and 52, AIRQ at weeks 12, 24 and 52, quality of life (Mini-AQLQ) at weeks 12, 24 and 52, postbronchodilator FEV1 at weeks 12, 24 and 52, severe exacerbations at week 24 and 52. Differences between groups in 8 AM serum cortisol at week 52. Adherence at week 52 in the two study arms. Factors related to triple and high-dose ICS/LABA failure and success (control) at week 52.

The results of this study will help physicians to decide the most appropriate therapeutic strategy for a large number of asthma patients: those who do not gain control with medium dose ICS/LABA. If non-inferiority of triple therapy vs high dose ICS/LABA is demonstrated, it could lead to a modification of the current guidelines.

Conditions: Asthma
Being tested: To compare in both treatment arms the percentage of patients controlled at week 52.
Keywords: Wheezing, Dyspnoea, Cough
Medical subject headings: Asthma, Respiratory Sounds, Dyspnea, Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

To compare in both treatment arms the percentage of patients controlled at week 52.Drug
Also called Triple therapy
Participants will be assigned to receive one of two therapeutic strategies: the same ICS/LABA combination at the higher doses or the same maintenance treatment at medium doses plus a LAMA.

Study groups in NCT05919394
Study group	Role	What they receive
Triple treatment with medium doses of CSI/LABA/LA	Active comparator	Medium-dose inhaled triple therapy of inhaled corticosteroid: IC, long-acting beta-agonist: LABA and anticholinergic: LAMA Receives: Drug: To compare in both treatment arms the percentage of patients controlled at week 52.
Treatment with high doses of CSI/LABA	Active comparator	High doses of of inhaled corticosteroid: IC and long-acting beta-agonist: LABA Receives: Drug: To compare in both treatment arms the percentage of patients controlled at week 52.

What is being measured

The primary outcome is the main question the study is designed to answer.

The percentage of patients controlled
The primary endpoint will be the percentage of patients controlled at week 52, with both an ACT score of 20 or greater and no severe exacerbations.
Measured: At 52 weeks

Secondary outcomes (9)

Percentage of patients controlled
Percentage of patients controlled at week 24, with both an ACT score of 20 or greater and no severe exacerbations.
Measured: At week 24
ASMA CONTROL TEST (ACT)
This is a 5-point scale. Scores range from 5 (poor asthma control) to 25 (total asthma control), with higher scores reflecting better asthma control. An ACT score >19 indicates well-controlled asthma. The minimally important difference (MID) is 3 points.
Measured: At weeks 12, 24 and 52
AIRQ
It is a patient assessment tool intended to help identify patients aged 12 years and older whose health may be at risk due to uncontrolled asthma. It is a 10-item, equally weighted asthma control questionnaire comprising 7 impairment items and 3 risk items.
Measured: At weeks 12, 24 and 52
Quality of life (Mini-AQLQ)
This instrument has 15 questions in the same domains as the original AQLQ (symptoms, activities, emotions and environment). A change in score greater than 0.5 can be considered clinically important.
Measured: At weeks 12, 24 and 52
Postbronchodilator FEV1
Performed with equipment and techniques that meet the standards developed by the Spanish Society of Respiratory Medicine (SEPAR) (18). Spirometry results will include pre-/ post-bronchodilator FEV1 (in litres) and % predicted value, FVC (in litres and % predicted) and FEV1/FVC ratio. Bronchodilator response is defined as an increase in post-bronchodilator FEV1 >12% and >0.2 l (measured 15 minutes after inhalation of 200 μg of salbutamol, using a spacer chamber) compared to pre-bronchodilator FEV1.
Measured: At weeks 12, 24 and 52
Severe exacerbations
Severe exacerbations
Measured: At week 24 and 52
Differences between groups in 8 AM serum cortiso
Differences between groups in 8 AM serum cortiso
Measured: At week 52
Adherence in the two study arms
Adherence in the two study arms
Measured: At week 52
Factors related to triple and high-dose ICS/LABA failure and success (control)
Factors related to triple and high-dose ICS/LABA failure and success (control)
Measured: At week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202314 Nov 2024

First posted26 Jun 2023
Study start1 Jun 2023
Primary completion30 Sep 2024
Study completion14 Nov 2024

Why it stopped: The study is closed due to lack of recruitment.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05919394
Sponsor's protocol ID: TRICORDA
Acronym: TRICORDA
Status last verified: Aug 2025
First submitted: 1 Jun 2023
Last updated: 4 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Increase in Inhaled Corticosteroid Dose vs Triple Therapy in T2-high Asthma Patients Who Remain Uncontrolled With Medium Dose Inhaled Corticosteroids/Long-acting β2 Adrenergic Combination: a Real-life Study. TRICORDA Study
ClinicalTrials.gov ID: NCT05919394
Acronym / sponsor ID: TRICORDA / TRICORDA
Conditions: Asthma
Keywords: Wheezing, Dyspnoea, Cough
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: The study is closed due to lack of recruitment.
Enrolment: 0 participants (actual)
Lead sponsor: Galaxia EmpíricaResearch network
Collaborators: Sociedad Española de Neumología y Cirugía Torácica
Study start: 1 Jun 2023 (actual)
Primary completion: 30 Sep 2024 (actual)
Study completion: 14 Nov 2024 (actual)
First posted: 26 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Triple treatment with medium doses of CSI/LABA/LA	Active comparator	Drug: To compare in both treatment arms the percentage of patients controlled at week 52.Medium-dose inhaled triple therapy of inhaled corticosteroid: IC, long-acting beta-agonist: LABA and anticholinergic: LAMA
Treatment with high doses of CSI/LABA	Active comparator	Drug: To compare in both treatment arms the percentage of patients controlled at week 52.High doses of of inhaled corticosteroid: IC and long-acting beta-agonist: LABA

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
To compare in both treatment arms the percentage of patients controlled at week 52.Also: Triple therapyParticipants will be assigned to receive one of two therapeutic strategies: the same ICS/LABA combination at the higher doses or the same maintenance treatment at medium doses plus a LAMA.	Drug	Treatment with high doses of CSI/LABA, Triple treatment with medium doses of CSI/LABA/LA

Primary outcome

The percentage of patients controlled
Time frame: At 52 weeks
The primary endpoint will be the percentage of patients controlled at week 52, with both an ACT score of 20 or greater and no severe exacerbations.

9 secondary outcomes

Percentage of patients controlled
Time frame: At week 24
ASMA CONTROL TEST (ACT)
Time frame: At weeks 12, 24 and 52
AIRQ
Time frame: At weeks 12, 24 and 52
Quality of life (Mini-AQLQ)
Time frame: At weeks 12, 24 and 52
Postbronchodilator FEV1
Time frame: At weeks 12, 24 and 52
Severe exacerbations
Time frame: At week 24 and 52
Differences between groups in 8 AM serum cortiso
Time frame: At week 52
Adherence in the two study arms
Time frame: At week 52
Factors related to triple and high-dose ICS/LABA failure and success (control)
Time frame: At week 52

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
Individual participant dataSharing planned: No

Related trials for Asthma

Active, not recruitingPhase 3
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma
Asthma
RecruitingPhase 1
A Phase 1 Trial of AMG 691 in Healthy Chinese and Japanese Volunteers
Healthy Participants
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 1/2
A Study of HB0056 in Adult Participants With Moderate to Severe Asthma
Asthma
Not yet recruitingPhase 1
Study of HXN-1013 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Health Adults, Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Luis Pérez De Llano, MD principal investigator

Sociedad Española de Neumología y Cirugía Torácica

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study of Asthma, run by Galaxia Empírica at 17 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percentage of patients controlled (time frame: At 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05919394.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025; AzTrials last refreshed its copy on 29 Oct 2026.