Chronic Obstructive Pulmonary Disease COPD
Conditions
Interventions
After inclusion long-acting bronchodilators will be washed-out for at least 7
days, and patients will be randomised to receive either Ultibro + placebo
nebulization or ipratropium/salbutamol nebuliz
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:;1. COPD, post-bronchodilator FEV1/FVC
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:;1. Non invasive ventilation 2. Saturation by pulse oxymetry <88% 3. Documented history of asthma 4. Instable cardiac disease within 6 months. 5. Known long QTC syndrome 6. Known EGFR <30 ml/min *1,73m2 7. Exacerbations of COPD or change of medication for COPD in the last 6 weeks prior to inclusion 8. Allergic reaction or intolerance for a substance used in one of the products or atropine or atropine derived substances 9. Pregnant or lactating females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve (AUC) from 0 to 6 hours of FEV1 with indacaterol and glycopyrronium, compared to nebulisation with ipratropium/salbutamol. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Borg dyspnea score at 30 min: change in Borg score at other time points, and proportion of patients reaching the MCID at all time points (15, 30, 60, 120 240 and 360 min) (1) 2. Changes in level of hyperinflation (by IC measurement), and proportion of participants reaching a difference of 100 ml. 3. Time to FEV1 increase of 100 ml 4. Peak effect of FEV1 from 0 to 6 hours 5. Time to peak of FEV1 6. FEV1 at all other time points (15, 30, 60, 120 240 and 360 min) | — |
Countries
Netherlands
Outcome results
None listed