COPD (chronic obstructive pulmonary disease)
Conditions
Interventions
Trade Name: Inuvair
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: Formoterol Fumarate
CAS Number: 43229-80-7
Other descriptive name: FORMOTEROL FUMARATE DIHYDRATE
Concen
Sponsors
University Hospital of Antwerp, Department of 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/FVC 60% predicted: IHC treatment allowed if exacerbation occurs after cessation of IHC treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating females or females at risk of pregnancy 2. Unstable patients who developed an exacerbation during the last 4 weeks 3. Use of CPAP or BiPAP device 4. Inability to carry out pulmonary function testing 5. Diagnosis of asthma as defined by the current GINA guidelines 6. Patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study 7. Patients with a QTc interval (Bazett’s formula) at the screening visit ECG test >450 msec 8. Cancer or any other chronic disease with poor prognosis and /or affecting patient status 9. History of alcohol or drug abuse 10. Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients 11. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study 12. Patients who received any investigational new drug within the last 4 weeks prior to the screening visit 13. Patients treated with any non-permitted concomitant medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To evaluate the effect of the combination on central and peripheral airway dimensions with Computational Fluid Dynamics (CFD).;Secondary Objective: Secondary to assess the effect of the combination on lung function (spirometry, body plethysmography) and BODE index and to evaluate the safety of this combination.;Primary end point(s): Effect of delivery treatment of Inuvair in COPD patients | — |
Countries
Belgium
Outcome results
None listed