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Completed

NCT Number: NCT00910793

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Antwerp

Antwerp, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inuvair

Drug

6 µg formoterol and 100 µg beclometasone dipropionate combination spray pMDI aerosol

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Wilfried De Backer

Other

Collaborators

  • UCB Pharma

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 1, 2009
Registry last updated
Jul 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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