Persistent Asthma Clinical Trial
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
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.
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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