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
|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|
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 (Clinical Trial)|
|Estimated Enrollment :||208 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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)
- 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
- 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)
- Critical errors with the inhaler [ Time Frame: 24 weeks ]Number of critical errors
- 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.)
- 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
- 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)
- Forced Expiratory Volume at first second (FEV1) [ Time Frame: 24 weeks ]Using the FEV1 score of the patient's spirometry
- Forced Vital Capacity (FVC) [ Time Frame: 24 weeks ]Using the FVC score of the patient's spirometry
- FEV1 / FVC ratio [ Time Frame: 24 weeks ]Using the FEV1 and FVC score of the patient's spirometry
- Safety of the drug in investigation. [ Time Frame: 24 weeks ]Type and incidence of adverse reactions
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
|Contact: Rubén Lesmes Escudero||+34 676 449 email@example.com|
|Contact: Susana Traseira Lugilde||+34 630 99 39 firstname.lastname@example.org|
|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|