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

Primary Purpose

Persistent Asthma

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
fluticasone/formoterol k-haler (medium strength)
Standard of care (ICs/LABA high strength)
Sponsored by
Mundipharma Pharmaceuticals S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Persistent Asthma

Eligibility Criteria

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

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Fluticasone/formoterol k-haler (medium strength)

    Standard of Care (SoC)

    Arm Description

    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)

    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)

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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)
    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
    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)
    Critical errors with the inhaler
    Number of critical errors
    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.)
    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
    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)
    Forced Expiratory Volume at first second (FEV1)
    Using the FEV1 score of the patient's spirometry
    Forced Vital Capacity (FVC)
    Using the FVC score of the patient's spirometry
    FEV1 / FVC ratio
    Using the FEV1 and FVC score of the patient's spirometry
    Safety of the drug in investigation.
    Type and incidence of adverse reactions

    Full Information

    First Posted
    February 11, 2020
    Last Updated
    July 2, 2020
    Sponsor
    Mundipharma Pharmaceuticals S.L.
    Collaborators
    Alpha Bioresearch S.L., Dynamic Solutions
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04271839
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The trial has been terminated early due to the SARS-CoV-2 pandemic.
    Study Start Date
    June 11, 2020 (Actual)
    Primary Completion Date
    May 2021 (Anticipated)
    Study Completion Date
    May 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mundipharma Pharmaceuticals S.L.
    Collaborators
    Alpha Bioresearch S.L., Dynamic Solutions

    4. Oversight

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

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Persistent Asthma

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fluticasone/formoterol k-haler (medium strength)
    Arm Type
    Experimental
    Arm Description
    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)
    Arm Title
    Standard of Care (SoC)
    Arm Type
    Active Comparator
    Arm Description
    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)
    Intervention Type
    Combination Product
    Intervention Name(s)
    fluticasone/formoterol k-haler (medium strength)
    Other Intervention Name(s)
    No other interventions
    Intervention Description
    2 inhalations every 12 hours
    Intervention Type
    Combination Product
    Intervention Name(s)
    Standard of care (ICs/LABA high strength)
    Other Intervention Name(s)
    No other interventions
    Intervention Description
    Depend of the ICs/LABA combination
    Primary Outcome Measure Information:
    Title
    Control of asthma
    Description
    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
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    Degree of asthma control according to GINA (Global Initiative for Asthma) questionnaire of four questions
    Description
    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)
    Time Frame
    24 weeks
    Title
    Success in asthma treatment
    Description
    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
    Time Frame
    24 weeks
    Title
    Adherence to treatment
    Description
    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)
    Time Frame
    24 weeks
    Title
    Critical errors with the inhaler
    Description
    Number of critical errors
    Time Frame
    24 weeks
    Title
    Patient satisfaction with the inhaler
    Description
    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.)
    Time Frame
    24 weeks
    Title
    Quality of Life of the patient
    Description
    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
    Time Frame
    24 weeks
    Title
    Severe asthmatic exacerbations
    Description
    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)
    Time Frame
    24 weeks
    Title
    Forced Expiratory Volume at first second (FEV1)
    Description
    Using the FEV1 score of the patient's spirometry
    Time Frame
    24 weeks
    Title
    Forced Vital Capacity (FVC)
    Description
    Using the FVC score of the patient's spirometry
    Time Frame
    24 weeks
    Title
    FEV1 / FVC ratio
    Description
    Using the FEV1 and FVC score of the patient's spirometry
    Time Frame
    24 weeks
    Title
    Safety of the drug in investigation.
    Description
    Type and incidence of adverse reactions
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age > or = 18 years. Objective diagnosis of asthma (according to GEMA 4.4) (Guía Española de Manejo del Asma) 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® 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. Exclusion Criteria: 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). Do not use a MART (MAintenance and Reliever Therapy) strategy within 3 months prior to inclusion or during the trial 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    José Luis Velasco Garrido, MD
    Organizational Affiliation
    Hospital Virgen de la Victoria
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Javier Domínguez Ortega, MD
    Organizational Affiliation
    Hospital La Paz
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Patricia García Sidro, MD
    Organizational Affiliation
    Hospital La plana
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ernesto Enrique Miranda, MD
    Organizational Affiliation
    Hospital General de Castellón
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ana Gómez-Bastero Fernández, MD
    Organizational Affiliation
    Hospital Universitario Virgen Macarena
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Alicia Padilla Galo, MD
    Organizational Affiliation
    Hospital Costa del Sol
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Fernando Florido López, MD
    Organizational Affiliation
    Hospital San Cecilio
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Joaquín Quiralte Enriquez, MD
    Organizational Affiliation
    Hospital Virgen del Rocío
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Antolín López Viña, MD
    Organizational Affiliation
    Hospital Puerta de Hierro
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Carlos Almonacid Sánchez, MD
    Organizational Affiliation
    Hospital Universitario Ramon y Cajal
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    María del Mar Gandolfo Cano, MD
    Organizational Affiliation
    Hospital de Fuenlabrada
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Paula López González, MD
    Organizational Affiliation
    Hospital Infanta Leonor
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Blanca Requejo Mañana, MD
    Organizational Affiliation
    Hospital Central de Asturias
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ana Pando Sandoval, MD
    Organizational Affiliation
    Hospital Central de Asturias
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Carlos Martínez Rivera, MD
    Organizational Affiliation
    Germans Trias i Pujol Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Xavier Muñoz Gall, MD
    Organizational Affiliation
    Hospital Vall d'Hebrón
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Gaspar Dalmau Duch, MD
    Organizational Affiliation
    Hospital Joan XXIII
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Luis Alejandro Pérez de Llano, MD
    Organizational Affiliation
    Hospital Lucus Augusti
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Abel Pallarés Sanmartín, MD
    Organizational Affiliation
    Complejo Hospitalario Universitario de Vigo
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Vanesa García Paz, MD
    Organizational Affiliation
    Complejo Hospitalario Universitario de Santiago de Compostela
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Francisco Javier Callejas González, MD
    Organizational Affiliation
    Hospital del Perpetuo Socorro de Albacete
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Patricia Prieto Montaño, MD
    Organizational Affiliation
    Hospital del Perpetuo Socorro de Albacete
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ana Tabar Purroy, MD
    Organizational Affiliation
    Complejo Hospitalario de Navarra
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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