Clinical trial
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
Name
TRICORDA
Description
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.
Trial arms
Trial start
2023-06-01
Estimated PCD
2024-09-30
Trial end
2024-09-30
Status
Recruiting
Phase
Early phase I
Treatment
To compare in both treatment arms the percentage of patients controlled at week 52.
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.
Arms:
Treatment with high doses of CSI/LABA, Triple treatment with medium doses of CSI/LABA/LA
Other names:
Triple therapy
Size
620
Primary endpoint
The percentage of patients controlled
At 52 weeks
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 620, 'type': 'ESTIMATED'}}
Updated at
2023-06-26
1 organization
1 product
1 indication
Organization
Galaxia EmpíricaIndication
Asthma