COPD (chronic obstructive pulmonary disease)
Conditions
Interventions
Trade Name: Ultibro Breezhaler
Product Name: indacaterol maleate / glycopyrronium bromide
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: INDACATEROL MALEATE
CAS Number: 7534
Sponsors
Medizinische Universität Innsbruck, Innere Medizin VI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Informed Consent Form signed by a patient; 2) Male and female adults = 40 years old; 3) Patients diagnosed with COPD accoridng to GOLD criteria with:a post-bronchodilations FEV1 10 YP; 6) No known allergies 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) A significant disease other than COPD (defined in protocol) diagnosed; 2) Pregnant of lactating women; 3) Never-smokers; 4) Hypersensitivity to IMP; 5) Known bronchial asthma; 6) Intake of prohibited medication (Daxas, theophylline, oral betamimetics); 7) Patients already participating in another clinical trial; 8) no informed consent form sign
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A change in the FEV1 parameter (Forced Expiratory Pressure in 1 Second) value in an acute broncholysis testing (pre-brochnolysis versus post-broncholysis) is supposed to distinguish between COPD and asthmatic patients. The aim of this study is to compare the effects of a dual bronchodilator (glycopyrronium 43 µg / indacaterol 85 µg) with a standard short-acting bronchodilator (salbutamol) on changes in the FEV1 values. ;Secondary Objective: Not applicable;Primary end point(s): change in the postbronchodilator FEV1 in comparison to the baseline measurement ;Timepoint(s) of evaluation of this end point: data collected during patient visits at day 0 and day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): change in the postbronchodilator %FEV1 predicted in comparison to the baseline measurement ;Timepoint(s) of evaluation of this end point: data collected during patient visits at day 0 and day 1 | — |
Countries
Austria
Contacts
Public ContactInnere Medizin VI, Pneumologie
Medizinische Universität Innsbruck
Outcome results
None listed