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Persistent Asthma

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

Sponsored by Mundipharma Pharmaceuticals S.L.

About this trial

Last updated 5 years ago

Study ID

EffICIENCY

Status

Withdrawn

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 4 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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