Clinical trial NCT01650441: Study to Assess the Effect of the NEXThaler® Device (DPI - Dry Powder Inhaler) on the Central and Peripheral Airway Dimensions in Asthmatic Patients
Official title: OPEN-LABEL, PROSPECTIVE EXPLORATORY STUDY TO ASSESS THE EFFECTS OF FORMOTEROL AND BECLOMETASONE DIPROPIONATE COMBINATION THERAPY USING A DPI DEVICE ON CENTRAL AND PERIPHERAL AIRWAY DIMENSIONS IN ASTHMATIC PATIENTS.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
NEXThaler®
Formoterol
Beclomethasone Dipropionate
Computational Fluid Dynamics
Functional Imaging
Central and Peripheral Airways
Asthma Control Test (ACT™)
Asthma Control Questionnaire (ACQ)
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Chiesi Farmaceutici S.p.A.
First posted: 2012-07-26
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the effect of the combination of formoterol and beclometasone dipropionate in a dry powder inhaler (NEXThaler®) on central and peripheral airway dimensions in asthmatic patients. Therefore Computational Fluid Dynamics (CFD) will be used. Further more, the effect of this combination therapy on lung function (spirometry, resistance and diffusion), the Asthma Control Test (ACT™) and the Asthma Control Questionnaire (ACQ) will be assessed and the safety will be evaluated.


Eligibility 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) (for definition please refer to the addendum in section 15) given for at least 6 weeks as large-particle formulation (non extra-fine).

   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 + LABA (for definition please refer to the addendum in section 15) given for at least 6 weeks as large-particle formulation (non extra-fine).
2. Male or female patients aged ≥18 years
3. Patients with a documented diagnosis of asthma according to the GINA guidelines
4. Patients with a co-operative attitude and ability to be trained to correctly use the Foster NEXThaler DPI
5. Written informed consent obtained

Exclusion Criteria:

1. Patients treated with extra-fine 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

Primary outcomes:
measure: Computational Fluid Dynamics (CFD)
timeFrame: CFD will be performed based on the images of 2 CT thorax scans in a dose reduction protocol (1 CT Thorax taken at baseline and 1 CT Thorax taken after 6 months of treatment with the NEXThaler® device).
Secondary outcomes:
measure: Lung function tests
timeFrame: Lung function tests will be performed at screening (visit 1), after 2 week run-in period both pre and post dose (visit 2), after 3 months treatment (visit 5), after 6 months treatment both pre and post dose (visit 8).
measure: Asthma Control
timeFrame: Asthma control will be monitored at screening (visit 1), after 2 week run-in period (visit 2), after 3 months treatment (visit 5), after 6 months treatment (visit 8).
measure: Safety
timeFrame: The safety of the NEXThaler® device will be monitored for the duration of the study, an expected average of 24 weeks.
Other outcomes:
Locations:
city: Edegem (Antwerp)
country: Belgium
facility: University Hospital of Antwerp
state: Antwerp
Study officials:
affiliation: University Hospital of Antwerp
name: Wilfried A De Backer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: