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

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ClinicalTrials.gov Identifier: NCT00910793
Recruitment Status : Completed
First Posted : June 1, 2009
Last Update Posted : July 10, 2013
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Wilfried De Backer, University Hospital, Antwerp

May 28, 2009
June 1, 2009
July 10, 2013
August 2008
August 2010   (Final data collection date for primary outcome measure)
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
The primary objective of this study is to evaluate the effect of the combination therapy on central and peripheral airway dimensions with CFD.
Complete list of historical versions of study NCT00910793 on ClinicalTrials.gov Archive Site
  • 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)
  • 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.
  • Exhaled Nitric Oxide (NO) [ Time Frame: Exhaled NO will be measured on visit 2, 3, 5 and 7 ]
  • Adverse events as a measure of safety [ Time Frame: Follow up of adverse events will be done during the entire study duration ]
The secondary objectives are to assess the effect of the combination therapy on exhaled NO, lung function, on subjective asthma control score and to evaluate the safety of the combination.
Not Provided
Not Provided
 
Study to Assess the Effect of Formoterol and Beclomethasone Dipropionate in Asthmatic Patients
Open-Label, Prospective Study to Assess the Effects of Formoterol and Beclometasone Dipropionate Combination Therapy on Central and Peripheral Airway Dimensions 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.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Asthma
Drug: Inuvair
6 µg formoterol and 100 µg beclometasone dipropionate combination spray pMDI aerosol
Inuvair
Intervention: Drug: Inuvair
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
36
August 2010
August 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00910793
PML_DOC_0802
Eudract number: 2008-002391-97
No
Not Provided
Not Provided
Wilfried De Backer, University Hospital, Antwerp
Wilfried De Backer
UCB Pharma
Principal Investigator: Wilfried A De Backer, MD, PhD University Hospital, Antwerp
University Hospital, Antwerp
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP