Status:
WITHDRAWN
Efficiency Control of Fluticasone/Formoterol K-haler (Medium Strength) vs ICS/LABA (High Strength) in Asthma Patients
Lead Sponsor:
Mundipharma Pharmaceuticals S.L.
Collaborating Sponsors:
Alpha Bioresearch S.L.
Dynamic Solutions
Conditions:
Persistent Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 incre...
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 morta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04271839
Start Date
June 11 2020
End Date
May 1 2021
Last Update
July 7 2020
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