Assess Particle Deposition and Acute Effects of Symbicort® Forte Turbohaler®) in COPD Patients.
This study has been completed.
Sponsor:
University Hospital, Antwerp
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
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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:
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).
Contacts and Locations
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 Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Budesonide Formoterol Symbicort Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013