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Completed

NCT Number: NCT01329276

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Antwerp

Edegem (Antwerp), Antwerp, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Symbicort® forte Turbohaler®

Drug

320 µg budesonide / 9 µg formoterol fumarate dihydrate

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • AstraZeneca

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Apr 5, 2011
Registry last updated
Apr 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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