Comparing triple therapy to high dose inhaled corticosteroids for uncontrolled asthma
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
This study is testing whether a new combination treatment for uncontrolled asthma can help people feel better compared to a high dose of their current medication.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 620 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Galaxia Empírica Research network |
| Locations | 17 sites (Inca, Baleares and 16 other locations) |
| Trial ID | NCT05919394 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of triple therapy versus high dose inhaled corticosteroids combined with long-acting beta2-agonists in patients with uncontrolled asthma who have high T2 biomarker levels. It is a randomized, open-label trial conducted over 12 months across 53 hospital asthma units. Participants will receive either the highest dose of their current ICS/LABA combination or the same maintenance therapy plus a long-acting anticholinergic. The primary endpoint is the percentage of patients achieving asthma control at week 52, assessed through the Asthma Control Test (ACT) and the occurrence of severe exacerbations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with uncontrolled asthma and high T2 biomarker levels despite medium dose ICS/LABA treatment.
Not a fit: Patients with severe uncontrolled asthma or those currently on high dose ICS/LABA or other excluded treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment strategy for patients with uncontrolled asthma, potentially improving their quality of life.
How similar studies have performed: Previous studies have explored similar therapeutic strategies, but this specific comparison of triple therapy versus high dose ICS/LABA in T2-high asthma is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Inca, Baleares and 16 other locations
- Hospital Comarcal de Inca - Tramuntana — Inca, Baleares, Spain (Recruiting)
- Hospital Universitario Son Espases — Palma De Mallorca, Baleares, Spain (Recruiting)
- Hospital Universitario de Cruces — Barakaldo, Bizkaia, Spain (Recruiting)
- Hospital Universitario Galdakao-Usansolo — Galdakao, Bizkaia, Spain (Recruiting)
- Hospital Universitario De Jerez — Jerez De La Frontera, Cádiz, Spain (Recruiting)
- Hospital Universitario de Navarra — Pamplona, Navarra, Spain (Recruiting)
- Hospital de Sagunto — Sagunto, Valencia, Spain (Recruiting)
- Hospital Universitario de A Coruña — A Coruña, Spain (Recruiting)
- Hospital General Universitario Dr. Balmis de Alicante — Alicante, Spain (Recruiting)
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (Recruiting)
- Hospital Universitario Virgen de las Nieves — Granada, Spain (Recruiting)
- Hospital Universitario Clínico San Cecilio — Granada, Spain (Recruiting)
- Hospital Universitario Lucus Augusti — Lugo, Spain (Recruiting)
- Hospital Universitario Ramón y Cajal — Madrid, Spain (Recruiting)
- Hospital Clínico Universitario de Salamanca — Salamanca, Spain (Recruiting)
- Hospital Universitario Doctor Peset — Valencia, Spain (Recruiting)
- Hospital Costa del Sol — Marbella, Álaga, Spain (Recruiting)
Study contacts
- Principal investigator: Luis Pérez De Llano, MD — Sociedad Española de Neumología y Cirugía Torácica
- Study coordinator: Luis Pérez De Llano, MD
- Email: eremos26@hotmail.com
- Phone: 666053549
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.