Asthma MedDRA version: 14.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Foster NEXThaler
Pharmaceutical Form: Inhalation powder
CAS Number: 43229-80-7
Other descriptive name: FORMOTEROL FUMARATE
Concentration unit: µg microgram(s)
Concentration type: equal
C
Sponsors
University Hospital of Antwerp
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with moderate asthma as defined by the current GINA guidelines. Patients can belong to 2 categories: Group 1 (n=15 to 20, at least 4 current smokers): Patients not well controlled (partially controlled or uncontrolled according to the GINA guidelines) when using medium daily dose of ICS or medium dose ICS + long acting inhaled 2-agonists (LABA) (given for at least 6 weeks as large-particle formulation (non-extrafine). Group 2 (n=15 to 20, at least 4 current smokers ): Patients well controlled (according to GINA guidelines) when using medium daily dose of ICS or medium daily dose of ICS + LABA given for at least 6 weeks as large-particle formulation (non extrafine). 2. Male or female patients aged =18 years 3. Patients with a documented diagnosis of asthma according to the GINA guidelines13 4. Patients with a co-operative attitude and ability to be trained to correctly use Foster NextHaler DPI 5. Written informed consent obtained 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Patients treated with extrafine ICS either alone or with LABA 2. Pregnant or lactating females or females at risk of pregnancy at screening and not willing to use an appropriate contraception method during the study period 3. Inability to carry out pulmonary function testing 4. History of near fatal asthma 5. Hospitalization due to asthma or symptomatic infection of the airways in the previous 8 weeks 6. Patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study 7. Cancer 8. Current alcohol or drug abuse 9. Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients 10. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study 11. Patients who received any investigational new drug within the last 4 weeks prior to the screening visit 12. Patients treated with any non-permitted concomitant medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The evaluation of the effect of the combination of formoterol and beclometasone using a DPI device on central and peripheral airway dimensions with Computational Fluid Dynamics (CFD).;Secondary Objective: The assessment of the effect of the combination of formoterol and beclometasone using a DPI device on lung function (spirometry, diffusion and resistance), on Asthma Control Test (ACT™) and Asthma Control Questionnaire (ACQ) ;Primary end point(s): -Total airway resistance for the segmented airways iRtot - Peripheral airway resistance(from 4th bifurcation on) for the segmented airways iRperph - Total airway volume for the segmented airways iVtot - Peripheral airway volume (from the 4th bifurcation on) for the segmented airways iVperiph - Relative compliance for each lobe iClobe-rel - Density of the lung parenchyma given per predifened lung zone Ldens ;Timepoint(s) of evaluation of this end point: April 2013 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Lung function parameters based on: -spirometry -resistance -diffusion asthma control based on questionnaires: -Asthma Control Test (ACT™) and the ACQ-7 items questionnaire;Timepoint(s) of evaluation of this end point: April 2013 | — |
Countries
Belgium
Contacts
Public ContactDepartment of Pneumology_Research
University Hospital of Antwerp
Outcome results
None listed