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

NCT ID: NCT04271839

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-11
• Study Completion Date: 2021-05-31

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.

Detailed Description

Asthma is a common chronic respiratory disease that affects about 300 million people worldwide. Although knowledge about asthma and its treatment has improved over the past decade, morbidity and mortality remain considerable.

Inhaled therapy is the treatment of choice in persistent asthma. Lower doses of drug are used that maximize the therapeutic effect and minimize side effects.

Inhaled therapy is administered primarily through inhalers. The goal is to deliver the maximum amount of medication to your therapeutic target in the lungs → lung deposit Each inhaler offers a different lung deposit figure (data in ideal conditions). However, asthma control also depends on other factors (inhalation technique, adhesion, asthma severity, drug dose, etc.).

The K-haler® inhaler device has obtained a high lung deposit (≈45% of the emitted dose) and an easy-to-use device.

In general, the rest of the CI / LABA inhalers offer lower deposit figures. They are between ≈10-40% of the dose.

Taking into account all that has been said in the introduction section, it has been decided to design this low-intervention clinical trial, to verify whether, those technical benefits of K-haler®, control asthma in a similar way using lower doses of IC .

If these hypotheses were confirmed, it would allow for an effective therapeutic option in the control of asthma using a lower therapeutic dose, saving IC and a lower probability of producing side effects.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Fluticasone/formoterol k-haler (medium strength)

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)

Group Type: EXPERIMENTAL

fluticasone/formoterol k-haler (medium strength)

Intervention Type: COMBINATION_PRODUCT

2 inhalations every 12 hours

Standard of Care (SoC)

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)

Group Type: ACTIVE_COMPARATOR

Standard of care (ICs/LABA high strength)

Intervention Type: COMBINATION_PRODUCT

Depend of the ICs/LABA combination

Interventions

fluticasone/formoterol k-haler (medium strength)

2 inhalations every 12 hours

Intervention Type: COMBINATION_PRODUCT

Standard of care (ICs/LABA high strength)

Depend of the ICs/LABA combination

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

No other interventions; No other interventions

Eligibility Criteria

Inclusion Criteria

1. Age > or = 18 years.

2. Objective diagnosis of asthma (according to GEMA 4.4) (Guía Española de Manejo del Asma)

3. Patients in treatment with a stable average dose of IC in a fixed dose combination of IC / LABA *, without changes in the dose or in the inhaler, during the 3 months prior to inclusion, in accordance with its approved indication and Data sheet. * Except for K-Haler®

4. Patients who need, according to medical criteria, a dose increase of IC in the current fixed IC / LABA combination.

5. Inhalation technique: no critical errors with the current inhaler after training.

6. Patient with uncontrolled asthma with an ACQ> 0.75 points (partially controlled or poorly controlled asthma).

7. Informed consent in signed writing.

Exclusion Criteria

1. 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).

2. ≥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.

3. Pregnancy or probability of being pregnant during the study.

4. Patient who, at the discretion of the investigator, does not have the capacity to complete the questionnaires.

5. Patient under treatment with monoclonal antibodies during the study.

6. Patient in another clinical trial.

7. Patient who has received an experimental drug in the last 30 days (12 weeks if it is a systemic steroid).

8. Do not use a MART (MAintenance and Reliever Therapy) strategy within 3 months prior to inclusion or during the trial

9. Patient in IC / LABA treatment according to MART strategy (Maintenance and Rescue).

10. Any contraindication expressed in the CI / LABA data sheet used.

11. Patient with poor adherence (TAI-10 ≤ 45)

12. Patients using an inhalation chamber

13. Patients with an index of Packages / year> 10

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alpha Bioresearch S.L.

OTHER

Sponsor Role: collaborator

Dynamic Solutions

INDUSTRY

Sponsor Role: collaborator

Mundipharma Pharmaceuticals S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Rubén Lesmes Escudero

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José Luis Velasco Garrido, MD

Role: STUDY_DIRECTOR

Hospital Virgen de la Victoria

Javier Domínguez Ortega, MD

Role: STUDY_DIRECTOR

Hospital La Paz

Patricia García Sidro, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital La plana

Ernesto Enrique Miranda, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital General de Castellón

Ana Gómez-Bastero Fernández, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen Macarena

Alicia Padilla Galo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Costa del Sol

Fernando Florido López, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital San Cecilio

Joaquín Quiralte Enriquez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Virgen del Rocío

Antolín López Viña, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Puerta de Hierro

Carlos Almonacid Sánchez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Ramon y Cajal

María del Mar Gandolfo Cano, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Fuenlabrada

Paula López González, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Infanta Leonor

Blanca Requejo Mañana, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Central de Asturias

Ana Pando Sandoval, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Central de Asturias

Carlos Martínez Rivera, MD

Role: PRINCIPAL_INVESTIGATOR

Germans Trias i Pujol Hospital

Xavier Muñoz Gall, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Vall d'Hebrón

Gaspar Dalmau Duch, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Joan XXIII

Luis Alejandro Pérez de Llano, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Lucus Augusti

Abel Pallarés Sanmartín, MD

Role: PRINCIPAL_INVESTIGATOR

Complejo Hospitalario Universitario de Vigo

Vanesa García Paz, MD

Role: PRINCIPAL_INVESTIGATOR

Complejo Hospitalario Universitario de Santiago de Compostela

Francisco Javier Callejas González, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital del Perpetuo Socorro de Albacete

Patricia Prieto Montaño, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital del Perpetuo Socorro de Albacete

Ana Tabar Purroy, MD

Role: PRINCIPAL_INVESTIGATOR

Complejo Hospitalario de Navarra

Other Identifiers

EffICIENCY

Identifier Type: -

Identifier Source: org_study_id