WithdrawnPhase 4
Triple vs High Dose Inhaled CORticosteroids
Key facts
- Who runs it
- Galaxia Empírica
- Where
- Spain17 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Phase
- Phase 4
- Started
- 1 Jun 2023
- Ended
- 14 Nov 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- To compare in both treatment arms the percentage of patients controlled at week 52.
- Record updated
- 4 September 2025
- Why it stopped
- The study is closed due to lack of recruitment.
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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 take part
- 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)
- Treatment with high dose ICS/LABA, LAMA, systemic corticosteroid, azithromycin, monoclonal antibody
- Patients who refuse to sign the informed consent form
- Medical situation that prevents the collection of study information
- Medical or administrative situation that prevents the patient from following up to a minimum of 52 weeks
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Triple treatment with medium doses of CSI/LABA/LAExisting treatment, for comparison
Medium-dose inhaled triple therapy of inhaled corticosteroid: IC, long-acting beta-agonist: LABA and anticholinergic: LAMA
Treatment: To compare in both treatment arms the percentage of patients controlled at week 52.
- Treatment with high doses of CSI/LABAExisting treatment, for comparison
High doses of of inhaled corticosteroid: IC and long-acting beta-agonist: LABA
Treatment: To compare in both treatment arms the percentage of patients controlled at week 52.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 4 September 2025