Efficiency Control of Fluticasone/Formoterol K-haler (Medium Strength) vs ICS/LABA (High Strength) in Asthma Patients

NCT04271839 | Withdrawn Phase 4

• 1 other identifier: EffICIENCY
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Clinical trial to demonstrate whether, in patients with moderate asthma, to treat with IC / LABA a medium dose, but not controlled, to achieve a similar degree of control by making a progressive increase of that treatment (CI / LABA a high dose) versus switching to fluticasone / Formoterol K-Haler at medium dose, under conditions of usual clinical practice.

Conditions

Persistent Asthma

Outcome Measures

Primary Outcomes (1)

• Control of asthma

  The control of asthma in patients with persistent asthma will be measured by scoring the ACQ-7 questionnaire (Asthma Control Questionnaire): Well controlled: ≤ 0.75, Partially controlled: from 0.75 to 1.50, Poorly controlled:\> 1.50

  24 weeks

Secondary Outcomes (11)

• Degree of asthma control according to GINA (Global Initiative for Asthma) questionnaire of four questions

  24 weeks

• Success in asthma treatment

  24 weeks

• Adherence to treatment

  24 weeks

• Critical errors with the inhaler

  24 weeks

• Patient satisfaction with the inhaler

  24 weeks

Study Arms (2)

Fluticasone/formoterol k-haler (medium strength)

EXPERIMENTAL

In this arm, uncontrolled patients who arrive at the consultation with their fixed combination of ICs (Inhaled CorticosteroidS) / LABA (Long-Acting Beta2-Agonist) (medium strength) will change their treatment to Fluticasone / formoterol k-haler (medium strength)

Combination Product: fluticasone/formoterol k-haler (medium strength)

Standard of Care (SoC)

ACTIVE COMPARATOR

In this arm, uncontrolled patients arriving at the consultation with their fixed combination of ICs / LABA (medium strength) will change their treatment to the same fixed combination of ICs / LABA (high strength)

Combination Product: Standard of care (ICs/LABA high strength)

Interventions

fluticasone/formoterol k-haler (medium strength) COMBINATION_PRODUCT

2 inhalations every 12 hours

Also known as: No other interventions

Fluticasone/formoterol k-haler (medium strength)

Standard of care (ICs/LABA high strength) COMBINATION_PRODUCT

Depend of the ICs/LABA combination

Also known as: No other interventions

Standard of Care (SoC)

Eligibility Criteria

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

You may qualify if:

• Age \> or = 18 years.
• Objective diagnosis of asthma (according to GEMA 4.4) (Guía Española de Manejo del Asma)
• Patients who need, according to medical criteria, a dose increase of IC in the current fixed IC / LABA combination.
• Inhalation technique: no critical errors with the current inhaler after training.
• Patient with uncontrolled asthma with an ACQ\> 0.75 points (partially controlled or poorly controlled asthma).
• Informed consent in signed writing.

You may not qualify if:

• Diagnosis of other respiratory pathology other than asthma (clinically relevant bronchiectasis, pulmonary fibrosis, COPD (Chronic Obstructive Pulmonary Disease) and others at the discretion of the investigator).
• ≥1 severe exacerbation (require the use of systemic corticosteroids - oral, suspension or injection - or increasing the dose of maintenance therapy for at least 3 days, or hospitalization or emergency room visits due to asthma requiring the use of systemic corticosteroids) in the last month or ≥3 in the previous 12 months.
• Pregnancy or probability of being pregnant during the study.
• Patient who, at the discretion of the investigator, does not have the capacity to complete the questionnaires.
• Patient under treatment with monoclonal antibodies during the study.
• Patient in another clinical trial.
• Patient who has received an experimental drug in the last 30 days (12 weeks if it is a systemic steroid).
• Patient in IC / LABA treatment according to MART strategy (Maintenance and Rescue).
• Any contraindication expressed in the CI / LABA data sheet used.
• Patient with poor adherence (TAI-10 ≤ 45)
• Patients using an inhalation chamber
• Patients with an index of Packages / year\> 10

Sponsors & Collaborators

• Mundipharma Pharmaceuticals S.L.: lead
• Alpha Bioresearch S.L.: collaborator
• Dynamic Solutions: collaborator

MeSH Terms

Interventions

Fluticasone; Standard of Care

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• José Luis Velasco Garrido, MD

  Hospital Virgen de la Victoria

  STUDY DIRECTOR

• Javier Domínguez Ortega, MD

  Hospital La Paz

  STUDY DIRECTOR

• Patricia García Sidro, MD

  Hospital La plana

  PRINCIPAL INVESTIGATOR

• Ernesto Enrique Miranda, MD

  Hospital General de Castellón

  PRINCIPAL INVESTIGATOR

• Ana Gómez-Bastero Fernández, MD

  Hospital Universitario Virgen Macarena

  PRINCIPAL INVESTIGATOR

• Alicia Padilla Galo, MD

  Hospital Costa del Sol

  PRINCIPAL INVESTIGATOR

• Fernando Florido López, MD

  Hospital San Cecilio

  PRINCIPAL INVESTIGATOR

• Joaquín Quiralte Enriquez, MD

  Hospital Virgen del Rocío

  PRINCIPAL INVESTIGATOR

• Antolín López Viña, MD

  Hospital Puerta de Hierro

  PRINCIPAL INVESTIGATOR

• Carlos Almonacid Sánchez, MD

  Hospital Universitario Ramon y Cajal

  PRINCIPAL INVESTIGATOR

• María del Mar Gandolfo Cano, MD

  Hospital de Fuenlabrada

  PRINCIPAL INVESTIGATOR

• Paula López González, MD

  Hospital Infanta Leonor

  PRINCIPAL INVESTIGATOR

• Blanca Requejo Mañana, MD

  Hospital Central de Asturias

  PRINCIPAL INVESTIGATOR

• Ana Pando Sandoval, MD

  Hospital Central de Asturias

  PRINCIPAL INVESTIGATOR

• Carlos Martínez Rivera, MD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

• Xavier Muñoz Gall, MD

  Hospital Vall d'Hebrón

  PRINCIPAL INVESTIGATOR

• Gaspar Dalmau Duch, MD

  Hospital Joan XXIII

  PRINCIPAL INVESTIGATOR

• Luis Alejandro Pérez de Llano, MD

  Hospital Lucus Augusti

  PRINCIPAL INVESTIGATOR

• Abel Pallarés Sanmartín, MD

  Complejo Hospitalario Universitario de Vigo

  PRINCIPAL INVESTIGATOR

• Vanesa García Paz, MD

  Complejo Hospitalario Universitario de Santiago de Compostela

  PRINCIPAL INVESTIGATOR

• Francisco Javier Callejas González, MD

  Hospital del Perpetuo Socorro de Albacete

  PRINCIPAL INVESTIGATOR

• Patricia Prieto Montaño, MD

  Hospital del Perpetuo Socorro de Albacete

  PRINCIPAL INVESTIGATOR

• Ana Tabar Purroy, MD

  Complejo Hospitalario de Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 17, 2020
• Study Start: June 11, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: July 7, 2020

Record last verified: 2020-02