Efficiency in symptom control of fluticasone/formoterol k-haler (medium strength) vs ICS/LABA (high strength) in asthma patients

Phase 1

• Conditions: Persistent moderate asthma uncontrolled; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-000302-28-ES
• Lead Sponsor: Mundipharma Pharmaceuticals S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-10
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

1. Age > or = 18 years.
2. Objective diagnosis of asthma (according to GEMA 4.4)
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 190
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

1. Diagnosis of other respiratory pathology other than asthma (clinically relevant bronchiectasis, pulmonary fibrosis, COPD 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 Rescue) 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified