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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00910793
Recruitment Status : Completed
First Posted : June 1, 2009
Last Update Posted : July 10, 2013
UCB Pharma
Information provided by (Responsible Party):
Wilfried De Backer, University Hospital, Antwerp

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Inuvair Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Arm Intervention/treatment
Inuvair Drug: Inuvair
6 µg formoterol and 100 µg beclometasone dipropionate combination spray pMDI aerosol

Primary Outcome Measures :
  1. Differences in airway dimension [ Time Frame: airway dimension will be measured at visit 2 and visit 7 ]

    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

Secondary Outcome Measures :
  1. Lung function tests: dynamic lung volumes, static lung volumes and airway resistances [ Time Frame: 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) ]

    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)

  2. Subjective asthma control score [ Time Frame: Asthma Control Test (ACT) will be performed on visit 1, 2, 3, 5 and 7 ]
    Asthma control scores will be obtained with the Dutch Asthma Control Test.

  3. Exhaled Nitric Oxide (NO) [ Time Frame: Exhaled NO will be measured on visit 2, 3, 5 and 7 ]
  4. Adverse events as a measure of safety [ Time Frame: Follow up of adverse events will be done during the entire study duration ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00910793

University Hospital Antwerp
Antwerp, Belgium, 2650
Sponsors and Collaborators
Wilfried De Backer
UCB Pharma
Principal Investigator: Wilfried A De Backer, MD, PhD University Hospital, Antwerp

Responsible Party: Wilfried De Backer, MD PhD, University Hospital, Antwerp Identifier: NCT00910793     History of Changes
Other Study ID Numbers: PML_DOC_0802
Eudract number: 2008-002391-97
First Posted: June 1, 2009    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: July 2013

Keywords provided by Wilfried De Backer, University Hospital, Antwerp:
Beclomethasone Dipropionate
Computational Fluid Dynamics
Functional Imaging
Central and Peripheral Airways

Additional relevant MeSH terms:
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists