Study to Assess the Effect of Formoterol and Beclomethasone Dipropionate in Asthmatic Patients

Study Overview
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Brief Summary
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The objective of this study is to evaluate the effect of the combination of formoterol and beclometasone dipropionate on central and peripheral airway dimensions in asthmatic patients using Computational Fluid Dynamics (CFD). Further more, the effect of this combination therapy on exhaled NO, lung function (spirometry, body plethysmography, diffusion and resistance) and subjective asthma control score as well as the safety of this combination will be assessed.

Official Title
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Open-Label, Prospective Study to Assess the Effects of Formoterol and Beclometasone Dipropionate Combination Therapy on Central and Peripheral Airway Dimensions in Asthmatic Patients

Conditions
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Asthma

Intervention / Treatment
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* Drug: Inuvair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with asthma as defined by the current Global INitiative for Asthma (GINA) guidelines: Male or female patients aged ≥18 years Patients with a documented positive response to the reversibility test within the 12 months preceding the screening visit or performed at screening visit after a wash-out of 2 days for long acting β2 agonists or a documented positive response to the methacholine challenge test Patients with a co-operative attitude and ability to be trained to correctly use the pressurized Metered Dose Inhaler (pMDI) Written informed consent obtained Exclusion Criteria: Pregnant or lactating females or females at risk of pregnancy Inability to carry out pulmonary function testing Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the current Global initiative for chronic Obstructive Lung Disease (GOLD) guidelines History of near fatal asthma Hospitalization due to asthma or symptomatic infection of the airways in the previous 8 weeks Current smokers or recent (less than one year) ex-smokers, defined as smoking at least 10 cigarettes/day 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 Patients with a QTc interval (Bazett's formula) at the screening visit Electrocardiogram (ECG) test >450 msec Cancer or any other chronic disease with poor prognosis and /or affecting patient status History of alcohol or drug abuse Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study Patients who received any investigational new drug within the last 8 weeks prior to the screening visit Patients treated with any non-permitted concomitant medication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Inuvair<br> | Drug: Inuvair<br>* 6 µg formoterol and 100 µg beclometasone dipropionate combination spray pMDI aerosol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in airway dimension | The primary objective of this study is to evaluate the effect of the combination therapy on central and peripheral airway dimensions with CFD. The following primary outcome parameters will be determined: Total airway resistance for the segmented airways Peripheral airway resistance(from 4th bifurcation on) for the segmented airways Total airway volume for the segmented airways Peripheral airway volume (from the 4th bifurcation on) for the segmented airways Relative compliance for each lobe Density of the lung parenchyma given per predefined lung zone | airway dimension will be measured at visit 2 and visit 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function tests: dynamic lung volumes, static lung volumes and airway resistances | The secondary outcome parameters that will be obtained with the lung function tests are: Dynamic lung volumes: Forced Expiratory Volume in 1 sec (FEV1), Forced Vital Capacity (FVC), Peak Expiratory Flow (PEF),Maximum expiratory flow when 50% of the FVC remain to be exhaled (MEF50) , Maximum expiratory flow when 25% of the FVC remain to be exhaled (MEF25) Static lung volumes: Vital Capacity (VC),Inspiratory Vital Capacity (IVC), Functional Residual Capacity (FCR), Total Lung Capacity (TLC) Airway resistances: Airway Resistance (Raw), Specific Airway Conductance(SGaw) (based on body plethysmography) | lung function tests will be perfomed at te following visits: screening, visit 1 (2 weeks after screening), visit 3 (6 weeks after screening), visit 5 (14 weeks after screening) and visit 7 (26 weeks after screening) | 
| Subjective asthma control score | Asthma control scores will be obtained with the Dutch Asthma Control Test. | Asthma Control Test (ACT) will be performed on visit 1, 2, 3, 5 and 7 | 
| Exhaled Nitric Oxide (NO) |  | Exhaled NO will be measured on visit 2, 3, 5 and 7 | 
| Adverse events as a measure of safety |  | Follow up of adverse events will be done during the entire study duration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Formoterol, Beclomethasone Dipropionate, Computational Fluid Dynamics, Functional Imaging, Central and Peripheral Airways