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

March 30, 2011
April 1, 2011
June 2010
November 2010   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01329276 on ClinicalTrials.gov Archive Site
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).
Same as current
Not Provided
Not Provided
 
Assess Particle Deposition and Acute Effects of Symbicort® Forte Turbohaler®) in COPD Patients.
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
Drug: Symbicort® forte Turbohaler®
320 µg budesonide / 9 µg formoterol fumarate dihydrate
  • Symbicort® forte Turbohaler®
    Intervention: Drug: Symbicort® forte Turbohaler®
  • Placebo Comparator: Placebo (lactose)
    Intervention: Drug: Symbicort® forte Turbohaler®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
January 2011
November 2010   (final data collection date for primary outcome measure)

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).
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01329276
PML_DOC_0905_/_ISSSYMB0020, 2009-016502-16
Yes
Wilfried A. De Backer, MD phD, University Hospital Antwerp
University Hospital, Antwerp
AstraZeneca
Principal Investigator: Wilfried A De Backer, MD PhD University Hospital, Antwerp
University Hospital, Antwerp
March 2011

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