Clinical trial NCT00910793: Study to Assess the Effect of Formoterol and Beclomethasone Dipropionate in Asthmatic Patients
Official title: Open-Label, Prospective Study to Assess the Effects of Formoterol and Beclometasone Dipropionate Combination Therapy on Central and Peripheral Airway Dimensions in Asthmatic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
Formoterol
Beclomethasone Dipropionate
Computational Fluid Dynamics
Functional Imaging
Central and Peripheral Airways
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2009-06-01
Enrollment: 29
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Differences in airway dimension
timeFrame: airway dimension will be measured at visit 2 and visit 7
Secondary outcomes:
measure: Lung function tests: dynamic lung volumes, static lung volumes and airway resistances
timeFrame: 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)
measure: Subjective asthma control score
timeFrame: Asthma Control Test (ACT) will be performed on visit 1, 2, 3, 5 and 7
measure: Exhaled Nitric Oxide (NO)
timeFrame: Exhaled NO will be measured on visit 2, 3, 5 and 7
measure: Adverse events as a measure of safety
timeFrame: Follow up of adverse events will be done during the entire study duration
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University Hospital Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Wilfried A De Backer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: