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

This study has been completed.
Sponsor:
Collaborator:
UCB, Inc.
Information provided by (Responsible Party):
Wilfried De Backer, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT00910793
First received: May 28, 2009
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Asthma
Drug: Inuvair
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Differences in airway dimension [ Time Frame: airway dimension will be measured at visit 2 and visit 7 ] [ Designated as safety issue: No ]

    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:
  • 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) ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Adverse events as a measure of safety [ Time Frame: Follow up of adverse events will be done during the entire study duration ] [ Designated as safety issue: Yes ]

Enrollment: 29
Study Start Date: August 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Inuvair Drug: Inuvair
6 µg formoterol and 100 µg beclometasone dipropionate combination spray pMDI aerosol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910793

Locations
Belgium
University Hospital Antwerp
Antwerp, Belgium, 2650
Sponsors and Collaborators
Wilfried De Backer
UCB, Inc.
Investigators
Principal Investigator: Wilfried A De Backer, MD, PhD University Hospital, Antwerp
  More Information

No publications provided

Responsible Party: Wilfried De Backer, MD PhD, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT00910793     History of Changes
Other Study ID Numbers: PML_DOC_0802, Eudract number: 2008-002391-97
Study First Received: May 28, 2009
Last Updated: July 9, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Antwerp:
Asthma
Formoterol
Beclomethasone Dipropionate
Computational Fluid Dynamics
Functional Imaging
Central and Peripheral Airways

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Beclomethasone
Formoterol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
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
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014