Triple vs High Dose Inhaled CORticosteroids

Asthma Clinical Trial

— TRICORDA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05919394
• Other study ID #: TRICORDA
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2023
• Source: Galaxia Empírica
• Contact: Luis Pérez De Llano, MD
• Phone: 666053549
• Email: eremos26[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 620
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario de A Coruña	A Coruña
Spain	Hospital General Universitario Dr. Balmis de Alicante	Alicante
Spain	Hospital Universitario de Cruces	Barakaldo	Bizkaia
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitario Galdakao-Usansolo	Galdakao	Bizkaia
Spain	Hospital Universitario Clínico San Cecilio	Granada
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Comarcal de Inca - Tramuntana	Inca	Baleares
Spain	Hospital Universitario De Jerez	Jerez De La Frontera	Cádiz
Spain	Hospital Universitario Lucus Augusti	Lugo
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Costa del Sol	Marbella	Álaga
Spain	Hospital Universitario Son Espases	Palma De Mallorca	Baleares
Spain	Hospital Universitario de Navarra	Pamplona	Navarra
Spain	Hospital de Sagunto	Sagunto	Valencia
Spain	Hospital Clínico Universitario de Salamanca	Salamanca
Spain	Hospital Universitario Doctor Peset	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Galaxia Empírica	Sociedad Española de Neumología y Cirugía Torácica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 52 weeks
Secondary	Percentage of patients controlled	Percentage of patients controlled at week 24, with both an ACT score of 20 or greater and no severe exacerbations.	At week 24
Secondary	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.	At weeks 12, 24 and 52
Secondary	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.	At weeks 12, 24 and 52
Secondary	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.	At weeks 12, 24 and 52
Secondary	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.	At weeks 12, 24 and 52
Secondary	Severe exacerbations	Severe exacerbations	At week 24 and 52
Secondary	Differences between groups in 8 AM serum cortiso	Differences between groups in 8 AM serum cortiso	At week 52
Secondary	Adherence in the two study arms	Adherence in the two study arms	At week 52
Secondary	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)	At week 52