Back to resultsEfficiency 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Withdrawn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
About this trial
This is an interventional other trial for Persistent Asthma
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
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
NCT ID
NCT04271839
First Posted
February 11, 2020
Last Updated
July 2, 2020
Sponsor
Mundipharma Pharmaceuticals S.L.
Collaborators
Alpha Bioresearch S.L., Dynamic Solutions
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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