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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Persistent Asthma
• Intervention / Treatment: Combination product: fluticasone/formoterol k-haler (medium strength); Combination product: Standard of care (ICs/LABA high strength)

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.

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Combination product: fluticasone/formoterol k-haler (medium strength); 2 inhalations every 12 hours; Other Names: No other interventions
Active Comparator: 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)	Combination product: Standard of care (ICs/LABA high strength); Depend of the ICs/LABA combination; Other Names: No other interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of asthma control according to GINA (Global Initiative for Asthma) questionnaire of four questions	Well Controlled (negative answer in the 4 questions), Partially controlled (affirmative answer in 1 or 2 of the answers), Uncontrolled (affirmative answer in 3 or 4 of the answers)	24 weeks
Success in asthma treatment	Defined as asthma patients who progress from poorly controlled asthma to partially or well controlled asthma, or from partially controlled asthma to controlled asthma, with no change in baseline asthma treatment after randomization Measured by scoring the ACQ-7 questionnaire: Well controlled: ≤ 0.75, Partially controlled: from 0.75 to 1.50, Poorly controlled:> 1.50	24 weeks
Adherence to treatment	Through TAI-12 questionnaire (Erratic Total Score 1-5 items, Deliberate Total Score 6-10 items, Unconscious Total Score 11-12 items) And through electronic prescription (if the amount of medication withdrawn in pharmacy matches that prescribed by the doctor)	24 weeks
Critical errors with the inhaler	Number of critical errors	24 weeks
Patient satisfaction with the inhaler	Through the FSI-10 (Feeling of Satisfaction with Inhaler) questionnaire (It consists of 10 questions, each with 5 response options on a 5-step Likert scale ("a lot", "a lot", "something", "little" and "very little") scored, respectively, from 5 to 1 (score total: 50). It evaluates the degree of patient satisfaction with the inhalation device and includes items related to comfort, difficulty, transportability and use.)	24 weeks
Quality of Life of the patient	Through Mini-AQLQ (Mini Asthma Quality of Life Questionnaire) questionnaire: This 15-item questionnaire is a short version of the complete 32-item questionnaire, but constitutes of the same 4 domains: symptoms, environment, emotions, activities, and covering a 2 week period. Scores range from 0-6 (lower is worse). The mini-AQLQ score is calculated as the average of domain items. The minimum clinically important difference is 0.5. This version has been developed to meet the needs of long-term monitoring, where efficiency may take precedent over precision of measurement	24 weeks
Severe asthmatic exacerbations	Number severe asthmatic exacerbations (require the use of systemic corticosteroids - oral, suspension or injection - or the increase in the dose of maintenance therapy for at least 3 days, or hospitalization or visits to the emergency room due to asthma that requires the use of systemic corticosteroids)	24 weeks
Forced Expiratory Volume at first second (FEV1)	Using the FEV1 score of the patient's spirometry	24 weeks
Forced Vital Capacity (FVC)	Using the FVC score of the patient's spirometry	24 weeks
FEV1 / FVC ratio	Using the FEV1 and FVC score of the patient's spirometry	24 weeks
Safety of the drug in investigation.	Type and incidence of adverse reactions	24 weeks

Collaborators and Investigators

• Sponsor: Mundipharma Pharmaceuticals S.L.
• Collaborators: Alpha Bioresearch S.L.; Dynamic Solutions
• Investigators: Study Director: José Luis Velasco Garrido, MD, Hospital Virgen de la Victoria; Study Director: Javier Domínguez Ortega, MD, Hospital La Paz; Principal Investigator: Patricia García Sidro, MD, Hospital la Plana; Principal Investigator: Ernesto Enrique Miranda, MD, Hospital General de Castellon; 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 Lopez Viña, MD, Hospital Puerta de Hierro; Principal Investigator: Carlos Almonacid Sánchez, MD, Hospital Universitario Ramón 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'Hebron; 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

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2020
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 2, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Adrenergic Agonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Fluticasone; Formoterol Fumarate
• Other Study ID Numbers: EffICIENCY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No