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Assess Particle Deposition and Acute Effects of Symbicort® Forte Turbohaler®) in COPD Patients.

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Symbicort® forte Turbohaler®
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Symbicort, Turbohaler, Computational Fluid Dynamics, Functional Imaging, Budesonide, Formoterol

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with documented COPD based on the following criteria:

    Smoking history of at least 10 pack-years and decreased Tiffeneau index (FEV1/(F)VC < 0.70).

  2. Patients should present severe COPD with an FEV1 between 50 and 30% of predicted (GOLD 3).
  3. Male or female patients aged ≥ 40 years.
  4. Patients should be treated according to GOLD guidelines before study start.
  5. Patients with, in the opinion of the investigator, a co-operative attitude and ability to be trained to correctly use the TurbohalerR.
  6. Maintained on stable respiratory medications for 6 weeks prior to visit 1.
  7. Written informed consent obtained.

Exclusion Criteria:

  1. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator.
  2. Inability to carry out pulmonary function testing.
  3. A respiratory infection or exacerbation of COPD in the four weeks prior to screening.
  4. Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study
  5. A history of asthma, cystic fibrosis, central bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
  6. Cancer or any other chronic disease with poor prognosis and/or affecting patient status.
  7. A history of thoracotomy with pulmonary resection.
  8. Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients.
  9. History of alcohol or drug abuse.
  10. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
  11. Patients who received any investigational new drug within the last 4 weeks prior to the screening visit.
  12. Patients treated with any non-permitted concomitant medication (see 7.2).

Sites / Locations

  • University Hospital Antwerp

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Placebo Comparator

Arm Label

Symbicort® forte Turbohaler®

Placebo (lactose)

Arm Description

Outcomes

Primary Outcome Measures

total airway resistance
To evaluate the effect of the combination therapy on the upper airway dimensions and to assess the particle deposition with Computational Fluid Dynamics (CFD). The parameters that will be obtained with CFD and used as primary outcome variables are total airway resistance and total airway volume.
total airway volume
To evaluate the effect of the combination therapy on the upper airway dimensions and to assess the particle deposition with Computational Fluid Dynamics (CFD). The parameters that will be obtained with CFD and used as primary outcome variables are total airway resistance and total airway volume.

Secondary Outcome Measures

effect of formoterol and budesonide combination therapy on lung function
The secondary objective of this study is to assess the effect of formoterol and budesonide combination therapy on lung function (spirometry, body plethysmography and resistance).

Full Information

First Posted
March 30, 2011
Last Updated
April 1, 2011
Sponsor
University Hospital, Antwerp
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01329276
Brief Title
Assess Particle Deposition and Acute Effects of Symbicort® Forte Turbohaler®) in COPD Patients.
Official Title
A Randomized, Double-blind, Placebo-controlled, Two Way Cross-over Study to Assess the Particle Deposition and Acute Effects of Formoterol and Budesonide Combination Therapy (Symbicort® Forte Turbohaler®) on the Upper Airway Dimensions in COPD Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Antwerp
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Computational Fluid Dynamics (CFD) is a new functional imaging method. Since CFD is very sensitive to detect small changes, it might be worthwhile to study the acute effect of formoterol and budesonide combination therapy (Symbicort® forte Turbohaler®) on the upper airway dimensions in severe COPD patients (GOLD III). The increased sensitivity of this technique makes it possible to detect changes in airway caliber in early stages. The regional distribution of resistance and the change in this parameter will provide more insight into the mode of action of the product.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Symbicort, Turbohaler, Computational Fluid Dynamics, Functional Imaging, Budesonide, Formoterol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Symbicort® forte Turbohaler®
Arm Type
Other
Arm Title
Placebo (lactose)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Symbicort® forte Turbohaler®
Intervention Description
320 µg budesonide / 9 µg formoterol fumarate dihydrate
Primary Outcome Measure Information:
Title
total airway resistance
Description
To evaluate the effect of the combination therapy on the upper airway dimensions and to assess the particle deposition with Computational Fluid Dynamics (CFD). The parameters that will be obtained with CFD and used as primary outcome variables are total airway resistance and total airway volume.
Title
total airway volume
Description
To evaluate the effect of the combination therapy on the upper airway dimensions and to assess the particle deposition with Computational Fluid Dynamics (CFD). The parameters that will be obtained with CFD and used as primary outcome variables are total airway resistance and total airway volume.
Secondary Outcome Measure Information:
Title
effect of formoterol and budesonide combination therapy on lung function
Description
The secondary objective of this study is to assess the effect of formoterol and budesonide combination therapy on lung function (spirometry, body plethysmography and resistance).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with documented COPD based on the following criteria: Smoking history of at least 10 pack-years and decreased Tiffeneau index (FEV1/(F)VC < 0.70). Patients should present severe COPD with an FEV1 between 50 and 30% of predicted (GOLD 3). Male or female patients aged ≥ 40 years. Patients should be treated according to GOLD guidelines before study start. Patients with, in the opinion of the investigator, a co-operative attitude and ability to be trained to correctly use the TurbohalerR. Maintained on stable respiratory medications for 6 weeks prior to visit 1. Written informed consent obtained. Exclusion Criteria: Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator. Inability to carry out pulmonary function testing. A respiratory infection or exacerbation of COPD in the four weeks prior to screening. Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study A history of asthma, cystic fibrosis, central bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease. Cancer or any other chronic disease with poor prognosis and/or affecting patient status. A history of thoracotomy with pulmonary resection. Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients. History of alcohol or drug abuse. 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 (see 7.2).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfried A De Backer, MD PhD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Antwerp
City
Edegem (Antwerp)
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

Assess Particle Deposition and Acute Effects of Symbicort® Forte Turbohaler®) in COPD Patients.

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