Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Trade Name: VentolinTM Metered-dose aerosol suspension
Pharmaceutical Form: Pressurised inhalation, suspension
Trade Name: Atrovent HFA
Pharmaceutical Form: Pressurised inhalation, solution
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. • 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.Patients who are allergic to salbutamol, ipratropium bromide or to another element of the product. 2.Patients allergic to sojalecithin and products on the basis of soja and peanut. 3.Patients who have or ever had glaucoma. 4.Patients with urinary problems, prostate hyperplasy or bladder-neck obstruction. Patients whose symptoms are controlled on treatment may be included. 5.Patients with a recent history (i.e. six months or less) of myocardial infarction. 6.Patients with any unstable or life threatening cardiac arrhythmia. 7.Patients with severe kidney insufficiency (creatinine clearance =50 ml/min)a. 8.Patients below the age of 40. 9.Patients who are pregnant or are breast-feeding. 10.Patients who are treated with other anticholinergic medications, that cannot be stopped during the study period. 11.A respiratory infection or exacerbation of COPD in the four weeks prior to screening. 12.Significant alcohol or drug abuse within the past 12 months. 13.Participation in another trial with an investigational drug within one month or six half lives (whichever is greater) prior to screening visit. 14.Known active tuberculosis. 15.A history of asthma, cystic fibrosis, central bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease. 16.A history of thoracotomy with pulmonary resection. 17.Active or untreated malignancy. 18.Use of oral corticosteroid medication at unstable doses (i.e. less than six weeks on a stable dose) or at doses = 10 mg/day. a Cockroft’s formulae should be applied: in male: creatinine clearance = (140-age) x weight / 72 x creatininemia in female: creatinine clearance = 0.85 x (140-age) x weight / 72 x creatininemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the effect of a single dose of salbutamol in comparison with ipratropium bromide on central and peripheral small airways with high-resolution/multislice CT scan imaging technique. ;Secondary Objective: The secondary objectives are to evaluate effects on spirometric indices (as Forced Expiratory Volume in one second (FEV1) and Tiffeneau index), to correlate these with the CFD based calculated airway volumes and resistances for both compounds and to evaluate the safety of the products. ;Primary end point(s): Effect of delivery treatment | — |
Countries
Belgium
Outcome results
None listed