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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01329276
First received: March 30, 2011
Last updated: April 1, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Symbicort® forte Turbohaler®
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • total airway resistance [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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).


Enrollment: 10
Study Start Date: June 2010
Study Completion Date: January 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Symbicort® forte Turbohaler® Drug: Symbicort® forte Turbohaler®
320 µg budesonide / 9 µg formoterol fumarate dihydrate
Placebo Comparator: Placebo (lactose) Drug: Symbicort® forte Turbohaler®
320 µg budesonide / 9 µg formoterol fumarate dihydrate

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  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: NCT01329276

Locations
Belgium
University Hospital Antwerp
Edegem (Antwerp), Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
AstraZeneca
Investigators
Principal Investigator: Wilfried A De Backer, MD PhD University Hospital, Antwerp
  More Information

No publications provided

Responsible Party: Wilfried A. De Backer, MD phD, University Hospital Antwerp
ClinicalTrials.gov Identifier: NCT01329276     History of Changes
Other Study ID Numbers: PML_DOC_0905_/_ISSSYMB0020, 2009-016502-16
Study First Received: March 30, 2011
Last Updated: April 1, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Antwerp:
COPD
Symbicort
Turbohaler
Computational Fluid Dynamics
Functional Imaging
Budesonide
Formoterol

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Budesonide
Formoterol
Symbicort
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 29, 2014