Comparison of standard and novel, double-active medications used to expand bronchi in diagnostic test in patients suffering from chronic lung disease (chronic obstructive pulmonary disease COPD and asthma).
- Conditions
- COPD (chronic obstructive pulmonary disease)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2014-002667-15-AT
- Lead Sponsor
- Medizinische Universität Innsbruck, Innere Medizin VI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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 < 80% of predicted FEV1 and a post-bronchodilations FEV1/FVC <70%;
4) Patients with stable medication for at least 4 weeks;
5) Active or former smoking status with > 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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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