Study to Assess the Effect of Formoterol and Beclomethasone Dipropionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Collaborator:
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
Wilfried De Backer, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01204034
First received: September 15, 2010
Last updated: June 29, 2012
Last verified: June 2012
  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 COPD patients using Computational Fluid Dynamics (CFD). Further more, the effect of this combination therapy on lung function (spirometry, body plethysmography), the BODE index, COPD assessment test (CAT) and Borg CR10 scale will be assessed and the safety will be evaluated.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Inuvair
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label, Prospective Exploratory Study to Assess the Effects of Formoterol and Beclometasone Dipropionate Combination Therapy on Central and Peripheral Airway Dimensions in COPD Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Peripheral airway resistance (from 4th bifurcation on) for the segmented airways [ Time Frame: at baseline and after 6 months of treatment ] [ Designated as safety issue: No ]
  • Total airway volume for the segmented airways [ Time Frame: at baseline and after 6 months of treatment ] [ Designated as safety issue: No ]
  • Peripheral airway volume (from the 4th bifurcation on) for the segmented airways [ Time Frame: at baseline and after 6 months of treatment ] [ Designated as safety issue: No ]
  • Relative compliance for each lobe [ Time Frame: at baseline and after 6 months of treatment ] [ Designated as safety issue: No ]
  • Density of the lung parenchyma given per predefined lung zone [ Time Frame: at baseline and after 6 months of treatment ] [ Designated as safety issue: No ]
  • Total airway resistance for the segmented airways [ Time Frame: at baseline and after 6 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BODE index [ Time Frame: at baseline (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment (visit 8) ] [ Designated as safety issue: No ]

    The BODE index is a multidimensional index of disease severity . The index uses following parameters:

    • body mass index (BMI)
    • degree of airflow obstruction (Forced Expiratory Volume in 1 second (FEV1): % of predicted)
    • functional dyspnea (Modified Medical Reseach Council (MMRC) dyspnea scale)
    • exercise capacity (6 minute walk distance (6MWD) - m)

  • COPD assessment test [ Time Frame: at screening (visit 1), at baseline (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment (visit 8) ] [ Designated as safety issue: No ]
    The COPD assessment measures the impact of COPD on a person's life.

  • Borg CR10 Scale [ Time Frame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) ] [ Designated as safety issue: No ]
    The Borg CR10 Scale measures the present dyspnea.

  • Adverse events as a measure of safety [ Time Frame: during the study patients will record record each day taken medication and any possible comments on the daily diary cards ] [ Designated as safety issue: Yes ]
    During the study patients will record record each day taken medication and any possible comments on the daily diary cards. Further more, patients are contacted at least once a month (either by phone or at a visit in the hospital).

  • Forced expiratory volume in 1 second (FEV1) [ Time Frame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) ] [ Designated as safety issue: No ]
  • Forced Vital Capacity (FVC) [ Time Frame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) ] [ Designated as safety issue: No ]
  • Peak Expiratory Flow (PEF) [ Time Frame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) ] [ Designated as safety issue: No ]
  • Maximum expiratory flow rate at 50% of vital capacity (MEF50) [ Time Frame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) ] [ Designated as safety issue: No ]
  • Maximal expiratory flow rate at 25% of vital capacity (MEF25) [ Time Frame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) ] [ Designated as safety issue: No ]
  • Vital capacity (VC) [ Time Frame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) ] [ Designated as safety issue: No ]
  • Inspiratory vital capacity (IVC) [ Time Frame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) ] [ Designated as safety issue: No ]
  • Functional residual capacity (FRC) [ Time Frame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) ] [ Designated as safety issue: No ]
  • Total Lung Capacity (TLC) [ Time Frame: At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) ] [ Designated as safety issue: No ]
  • Airway resistance (Raw) [ Time Frame: At baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) ] [ Designated as safety issue: No ]
  • Specific airways conductance (SGaw) [ Time Frame: At baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8) ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: September 2010
Study Completion Date: June 2012
Primary Completion Date: March 2012 (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:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with documented COPD based on the following criteria:

Smoking history of at least 10 pack-years Decreased Tiffeneau index: FEV1/FVC < 0.70

  • Male or female patients aged ≥ 40 years
  • Patients should be treated according to the 'Global initiative for chronic Obstructive Lung Disease' (GOLD) guidelines
  • Patients who present
  • Moderate COPD with an FEV1 between 50 and 80% of predicted GOLD 2)
  • Severe COPD with an FEV1 between 30 and 50% of predicted (GOLD 3)
  • Very severe COPD with an FEV1 lower than 30% of predicted (GOLD 4)
  • Patients will be maintained on stable respiratory medications for 6 weeks prior to screening
  • Patients with a co-operative attitude and ability to be trained to correctly use the pMDI
  • Written informed consent obtained

Exclusion Criteria:

  • Pregnant or lactating females or females at risk of pregnancy
  • Unstable patients who developed an exacerbation during the last 4 weeks
  • Inability to carry out pulmonary function testing
  • Diagnosis of asthma as defined by the current 'Global Initiative for Asthma' (GINA) guidelines
  • 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 4 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: NCT01204034

Locations
Belgium
University Hospital of Antwerp
Edegem (Antwerp), Antwerp, Belgium, B-2650
Sponsors and Collaborators
University Hospital, Antwerp
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Wilfried A De Backer, MD PhD University Hospital of Antwerp
  More Information

No publications provided

Responsible Party: Wilfried De Backer, MD PhD, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT01204034     History of Changes
Other Study ID Numbers: PML-DOC-1003, 2010-019864-36
Study First Received: September 15, 2010
Last Updated: June 29, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Antwerp:
COPD
Formoterol
Beclomethasone Dipropionate
Computational Fluid Dynamics
Functional Imaging
Central and Peripheral Airways
BODE index
COPD Assessment Test (CAT)
Borg CR10 scale

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Beclomethasone
Formoterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014