Clinical trial NCT04271839: Efficiency Control of Fluticasone/Formoterol K-haler (Medium Strength) vs ICS/LABA (High Strength) in Asthma Patients
Official title: Open Randomized Low Interventional Clinical Trial to Compare Efficiency in Control Symptoms Between Fluticasone Propionate/Formoterol K-haler (Medium Strength) vs High Strength ICS/LABA in the Treatment of Patients With Persistent Asthma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Persistent Asthma
Lead sponsor: Mundipharma Pharmaceuticals S.L.
Sponsor class: INDUSTRY
Collaborators: name: Alpha Bioresearch S.L.
name: Dynamic Solutions
First posted: 2020-02-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Control of asthma
timeFrame: 24 weeks
Secondary outcomes:
measure: Degree of asthma control according to GINA (Global Initiative for Asthma) questionnaire of four questions
timeFrame: 24 weeks
measure: Success in asthma treatment
timeFrame: 24 weeks
measure: Adherence to treatment
timeFrame: 24 weeks
measure: Critical errors with the inhaler
timeFrame: 24 weeks
measure: Patient satisfaction with the inhaler
timeFrame: 24 weeks
measure: Quality of Life of the patient
timeFrame: 24 weeks
measure: Severe asthmatic exacerbations
timeFrame: 24 weeks
measure: Forced Expiratory Volume at first second (FEV1)
timeFrame: 24 weeks
measure: Forced Vital Capacity (FVC)
timeFrame: 24 weeks
measure: FEV1 / FVC ratio
timeFrame: 24 weeks
measure: Safety of the drug in investigation.
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Virgen de la Victoria
name: José Luis Velasco Garrido, MD
role: STUDY_DIRECTOR
affiliation: Hospital La Paz
name: Javier Domínguez Ortega, MD
role: STUDY_DIRECTOR
affiliation: Hospital La plana
name: Patricia García Sidro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General de Castellón
name: Ernesto Enrique Miranda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Virgen Macarena
name: Ana Gómez-Bastero Fernández, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Costa del Sol
name: Alicia Padilla Galo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital San Cecilio
name: Fernando Florido López, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Virgen del Rocío
name: Joaquín Quiralte Enriquez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Puerta de Hierro
name: Antolín López Viña, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Ramon y Cajal
name: Carlos Almonacid Sánchez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Fuenlabrada
name: María del Mar Gandolfo Cano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Infanta Leonor
name: Paula López González, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Central de Asturias
name: Blanca Requejo Mañana, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Central de Asturias
name: Ana Pando Sandoval, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Germans Trias i Pujol Hospital
name: Carlos Martínez Rivera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Vall d'Hebrón
name: Xavier Muñoz Gall, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Joan XXIII
name: Gaspar Dalmau Duch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Lucus Augusti
name: Luis Alejandro Pérez de Llano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Complejo Hospitalario Universitario de Vigo
name: Abel Pallarés Sanmartín, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Complejo Hospitalario Universitario de Santiago de Compostela
name: Vanesa García Paz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Perpetuo Socorro de Albacete
name: Francisco Javier Callejas González, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Perpetuo Socorro de Albacete
name: Patricia Prieto Montaño, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Complejo Hospitalario de Navarra
name: Ana Tabar Purroy, MD
role: PRINCIPAL_INVESTIGATOR
References: