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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003249-16 | EudraCT Number |
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| Name | Class |
|---|---|
| Chiesi Farmaceutici S.p.A. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| beclomethasone dipropionate + formoterol fumarate | Experimental | All patients will be treated with the active product. No placebo arm will be used. The active product is a fixed combination containing extra-fine beclometasone dipropionate and formoterol fumarate in a new dry powder inhaler device, NEXThaler® (Chiesi Farmaceutici, Parma, Italy). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg | Drug | In this trial, patients will take two inhalations of the beclometasone dipropionate 100 µg and formoterol fumarate 6 µg combination therapy (Foster®) using a Dry Powder Inhaler (NEXThaler®) device in the morning and two inhalations in the evening, for a total of 4 inhalations a day (total daily dose: BDP 400 µg / FF 24 µg). |
| Measure | Description | Time Frame |
|---|---|---|
| Computational Fluid Dynamics (CFD) | The parameters that will be obtained with the CFD based imaging and used as primary outcome parameters are:
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Lung function tests | The parameters that will be obtained with the described lung function tests are:
| 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). |
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Inclusion Criteria:
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).
Male or female patients aged ≥18 years
Patients with a documented diagnosis of asthma according to the GINA guidelines
Patients with a co-operative attitude and ability to be trained to correctly use the Foster NEXThaler DPI
Written informed consent obtained
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilfried A De Backer, MD PhD | University Hospital of Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Antwerp | Edegem (Antwerp) | Antwerp | B-2650 | Belgium |
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| CT thorax | Radiation | CT scan of the thorax will be performed at 2 time points: baseline and after 6 months of treatment. The CT scan will be performed with low dose radiation using the multi-slice CT scan. Scanning will be performed at Functional Residual Capacity and Total Lung Capacity (2 times 8 sec). The lung volumes will be controlled using adapted spirometry during the CT procedure. The radiation dose will be reduced by reduction of the tube current and voltage. These settings depend on the patients' weight (1mAs/kg). In addition to this there will be an increase in noise factor to further reduce the radiation dose. |
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| Asthma Control | Asthma Control will be monitored during the study using 2 different questionnaires: the Asthma Control Test (ACTâ„¢) and the Asthma Control Questionnaire (ACQ, both the 6-items and the 7-items test will be used.) | 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). |
| Safety | During the study the patient will be told to record each day taken medication and any possible comments on the daily diary cards, starting from visit 1. Further more, the patient will be contacted at least once a month (either by phone or a visit in the hospital.) | The safety of the NEXThaler® device will be monitored for the duration of the study, an expected average of 24 weeks. |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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