COPD
Conditions
Interventions
Trade Name: Symbicort forte Turbohaler
Pharmaceutical Form: Inhalation powder
CAS Number: 0
Other descriptive name: FORMOTEROL FUMARATE DIHYDRATE
Concentration unit: µg microgram(s)
Concentration type
Sponsors
University Hospital Antwerp : Department Respiratory Medicine
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: 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 Objective: Secondary objectives: 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).;Primary end point(s): Effect of delivery treatment. | — |
Countries
Belgium
Outcome results
None listed