Triple vs High Dose Inhaled CORticosteroids

NCT05919394 | Withdrawn Phase 4

• 1 other identifier: TRICORDA
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 17

Brief 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.

Conditions

Asthma

Keywords

Wheezing; Dyspnoea; Cough

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Percentage of patients controlled

  At week 24

• ASMA CONTROL TEST (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

Study Arms (2)

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

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

Drug: To compare in both treatment arms the percentage of patients controlled at week 52.

Interventions

To compare in both treatment arms the percentage of patients controlled at week 52. DRUG

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.

Also known as: Triple therapy

Treatment with high doses of CSI/LABA; Triple treatment with medium doses of CSI/LABA/LA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galaxia Empírica: lead
• Sociedad Española de Neumología y Cirugía Torácica: collaborator

Study Sites (17)

Hospital Universitario de A Coruña

A Coruña, A Coruña, 15006, Spain

Location

Hospital General Universitario Dr. Balmis de Alicante

Alicante, Alicante, 03010, Spain

Location

Hospital Comarcal de Inca - Tramuntana

Inca, Balearic Islands, 07300, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospital Universitario de Cruces

Barakaldo, Bizkaia, 48903, Spain

Location

Hospital Universitario Galdakao-Usansolo

Galdakao, Bizkaia, 48960, Spain

Location

Hospital Universitario De Jerez

Jerez de la Frontera, Cádiz, 11407, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Granada, 18014, Spain

Location

Hospital Universitario Clínico San Cecilio

Granada, Granada, 18016, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, Lugo, 27003, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Clínico Universitario de Salamanca

Salamanca, Salamanca, 37007, Spain

Location

Hospital de Sagunto

Sagunto, Valencia, 46520, Spain

Location

Hospital Universitario Doctor Peset

Valencia, Valencia, 46017, Spain

Location

Hospital Costa del Sol

Marbella, Álaga, 29603, Spain

Location

MeSH Terms

Conditions

Asthma; Respiratory Sounds; Dyspnea; Cough

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Study Officials

• Luis Pérez De Llano, MD

  Sociedad Española de Neumología y Cirugía Torácica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 26, 2023
• Study Start: June 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: November 14, 2024
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (17)