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

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ClinicalTrials.gov Identifier: NCT04271839
Recruitment Status : Not yet recruiting
First Posted : February 17, 2020
Last Update Posted : February 18, 2020
Sponsor:
Collaborators:
Alpha Bioresearch S.L.
Dynamic Solutions
Information provided by (Responsible Party):
Rubén Lesmes Escudero, Mundipharma Pharmaceuticals S.L.

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.

Condition or disease Intervention/treatment Phase
Persistent Asthma Combination Product: fluticasone/formoterol k-haler (medium strength) Combination Product: Standard of care (ICs/LABA high strength) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021


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 Name: 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 Name: No other interventions




Primary Outcome Measures :
  1. Control of asthma [ Time Frame: 24 weeks ]
    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 :
  1. Degree of asthma control according to GINA (Global Initiative for Asthma) questionnaire of four questions [ Time Frame: 24 weeks ]
    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)

  2. Success in asthma treatment [ Time Frame: 24 weeks ]

    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


  3. Adherence to treatment [ Time Frame: 24 weeks ]
    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)

  4. Critical errors with the inhaler [ Time Frame: 24 weeks ]
    Number of critical errors

  5. Patient satisfaction with the inhaler [ Time Frame: 24 weeks ]
    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.)

  6. Quality of Life of the patient [ Time Frame: 24 weeks ]

    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


  7. Severe asthmatic exacerbations [ Time Frame: 24 weeks ]
    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)

  8. Forced Expiratory Volume at first second (FEV1) [ Time Frame: 24 weeks ]
    Using the FEV1 score of the patient's spirometry

  9. Forced Vital Capacity (FVC) [ Time Frame: 24 weeks ]
    Using the FVC score of the patient's spirometry

  10. FEV1 / FVC ratio [ Time Frame: 24 weeks ]
    Using the FEV1 and FVC score of the patient's spirometry

  11. Safety of the drug in investigation. [ Time Frame: 24 weeks ]
    Type and incidence of adverse reactions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04271839


Contacts
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Contact: Rubén Lesmes Escudero +34 676 449 825 ruben.lesmes@mundipharma.es
Contact: Susana Traseira Lugilde +34 630 99 39 00 susana.traseira@mundipharma.es

Sponsors and Collaborators
Mundipharma Pharmaceuticals S.L.
Alpha Bioresearch S.L.
Dynamic Solutions
Investigators
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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 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

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Responsible Party: Rubén Lesmes Escudero, Clinical Professor, Mundipharma Pharmaceuticals S.L.
ClinicalTrials.gov Identifier: NCT04271839    
Other Study ID Numbers: EffICIENCY
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Formoterol Fumarate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action