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Triple vs High Dose Inhaled CORticosteroids (TRICORDA)

Primary Purpose

Asthma

Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
To compare in both treatment arms the percentage of patients controlled at week 52.
Sponsored by
Galaxia Empírica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Wheezing, Dyspnoea, Cough

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Comarcal de Inca - TramuntanaRecruiting
  • Hospital Universitario Son EspasesRecruiting
  • Hospital Universitario de CrucesRecruiting
  • Hospital Universitario Galdakao-UsansoloRecruiting
  • Hospital Universitario De JerezRecruiting
  • Hospital Universitario de NavarraRecruiting
  • Hospital de SaguntoRecruiting
  • Hospital Universitario de A CoruñaRecruiting
  • Hospital General Universitario Dr. Balmis de AlicanteRecruiting
  • Hospital de la Santa Creu i Sant PauRecruiting
  • Hospital Universitario Virgen de las NievesRecruiting
  • Hospital Universitario Clínico San CecilioRecruiting
  • Hospital Universitario Lucus AugustiRecruiting
  • Hospital Universitario Ramón y CajalRecruiting
  • Hospital Clínico Universitario de SalamancaRecruiting
  • Hospital Universitario Doctor PesetRecruiting
  • Hospital Costa del SolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Triple treatment with medium doses of CSI/LABA/LA

Treatment with high doses of CSI/LABA

Arm Description

Medium-dose inhaled triple therapy of inhaled corticosteroid: IC, long-acting beta-agonist: LABA and anticholinergic: LAMA

High doses of of inhaled corticosteroid: IC and long-acting beta-agonist: LABA

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of patients controlled
Percentage of patients controlled at week 24, with both an ACT score of 20 or greater and no severe exacerbations.
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.
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.
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.
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.
Severe exacerbations
Severe exacerbations
Differences between groups in 8 AM serum cortiso
Differences between groups in 8 AM serum cortiso
Adherence in the two study arms
Adherence in the two study arms
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)

Full Information

First Posted
June 1, 2023
Last Updated
June 16, 2023
Sponsor
Galaxia Empírica
Collaborators
Sociedad Española de Neumología y Cirugía Torácica
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1. Study Identification

Unique Protocol Identification Number
NCT05919394
Brief Title
Triple vs High Dose Inhaled CORticosteroids
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galaxia Empírica
Collaborators
Sociedad Española de Neumología y Cirugía Torácica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Wheezing, Dyspnoea, Cough

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
620 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Triple treatment with medium doses of CSI/LABA/LA
Arm Type
Active Comparator
Arm Description
Medium-dose inhaled triple therapy of inhaled corticosteroid: IC, long-acting beta-agonist: LABA and anticholinergic: LAMA
Arm Title
Treatment with high doses of CSI/LABA
Arm Type
Active Comparator
Arm Description
High doses of of inhaled corticosteroid: IC and long-acting beta-agonist: LABA
Intervention Type
Drug
Intervention Name(s)
To compare in both treatment arms the percentage of patients controlled at week 52.
Other Intervention Name(s)
Triple therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The percentage of patients controlled
Description
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.
Time Frame
At 52 weeks
Secondary Outcome Measure Information:
Title
Percentage of patients controlled
Description
Percentage of patients controlled at week 24, with both an ACT score of 20 or greater and no severe exacerbations.
Time Frame
At week 24
Title
ASMA CONTROL TEST (ACT)
Description
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.
Time Frame
At weeks 12, 24 and 52
Title
AIRQ
Description
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.
Time Frame
At weeks 12, 24 and 52
Title
Quality of life (Mini-AQLQ)
Description
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.
Time Frame
At weeks 12, 24 and 52
Title
Postbronchodilator FEV1
Description
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.
Time Frame
At weeks 12, 24 and 52
Title
Severe exacerbations
Description
Severe exacerbations
Time Frame
At week 24 and 52
Title
Differences between groups in 8 AM serum cortiso
Description
Differences between groups in 8 AM serum cortiso
Time Frame
At week 52
Title
Adherence in the two study arms
Description
Adherence in the two study arms
Time Frame
At week 52
Title
Factors related to triple and high-dose ICS/LABA failure and success (control)
Description
Factors related to triple and high-dose ICS/LABA failure and success (control)
Time Frame
At week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luis Pérez De Llano, MD
Phone
666053549
Email
eremos26@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
FIDIS
Phone
982296698
Email
investigacionlugo.fidis@sergas.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Pérez De Llano, MD
Organizational Affiliation
Sociedad Española de Neumología y Cirugía Torácica
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Comarcal de Inca - Tramuntana
City
Inca
State/Province
Baleares
ZIP/Postal Code
07300
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Serrano Pariente, MD
Facility Name
Hospital Universitario Son Espases
City
Palma De Mallorca
State/Province
Baleares
ZIP/Postal Code
07120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco de Borja Garcia-Cosio Piqueras, MD
Facility Name
Hospital Universitario de Cruces
City
Barakaldo
State/Province
Bizkaia
ZIP/Postal Code
48903
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuria Marina Malanda, MD
Facility Name
Hospital Universitario Galdakao-Usansolo
City
Galdakao
State/Province
Bizkaia
ZIP/Postal Code
48960
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel Ines Urrutia Landa, MD
Facility Name
Hospital Universitario De Jerez
City
Jerez De La Frontera
State/Province
Cádiz
ZIP/Postal Code
11407
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Gregorio Soto, MD
Facility Name
Hospital Universitario de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pilar Cebollero Rivas, MD
Facility Name
Hospital de Sagunto
City
Sagunto
State/Province
Valencia
ZIP/Postal Code
46520
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Palop Cervera, MD
Facility Name
Hospital Universitario de A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Blanco Aparicio, MD
Facility Name
Hospital General Universitario Dr. Balmis de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mº Cleofe Fernandez Aracil, MD
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicente Plaza, MD
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Concepción Morales Garcia, MD
Facility Name
Hospital Universitario Clínico San Cecilio
City
Granada
ZIP/Postal Code
18016
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Fernando Cassini Gomez de Cadiz, MD
Facility Name
Hospital Universitario Lucus Augusti
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Perez de Llano, MD
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Sanchez Cuellar, MD
Facility Name
Hospital Clínico Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacinto Ramos Gonzalez, MD
Facility Name
Hospital Universitario Doctor Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Martinez Moragon, MD
Facility Name
Hospital Costa del Sol
City
Marbella
State/Province
Álaga
ZIP/Postal Code
29603
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicia Padilla Galo, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Triple vs High Dose Inhaled CORticosteroids

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