Single Dose Ultibro Breezhaler by Sd-DPI Versus Ipratropium/Salbutamol by Nebulizer in COPD
Status:
Completed
Trial end date:
2017-09-29
Target enrollment:
Participant gender:
Summary
Rationale:
Inhaled bronchodilators, beta-2-agonist or anticholinergic or combinations, can be delivered
by several types of devices: dry powder (DPI), pressurized metered dose inhalers (pMDI), and
wet nebulizers. Wet nebulization is available for short-acting bronchodilators only, is
cumbersome, and, importantly, has never been scientifically been proven to be more
efficacious than delivery by the other two methods. Yet many patients are happy with wet
nebulization and in many clinics this administration method prevails. The investigators
believe that combined long-acting bronchodilators, are more efficacious than combined short
acting bronchodilators per nebulizers.
Objective:
To test the hypothesis that: The combination of the two long-acting bronchodilators
indacaterol and glycopyrronium by dry powder inhalation confers a superior improvement
compared to nebulisation with ipratropium/salbutamol, when administered as single dose in
patients with stable state chronic obstructive pulmonary disease (COPD).
Study design: Investigator initiated, randomised, active controlled, cross-over double-blind
(and therefore double-dummy), study comparing the effects of single dose
indacaterol/glycopyrronium 110/50 Breezhaler® versus single dose ipratropium/salbutamol
nebulisation in patients with COPD in stable state Study population: Patients visiting the
outpatient clinics or from general practitioner (GP) practices with COPD GOLD stage A-D, and
(FEV1) post-bronchodilator FEV1/ forced vital capacity (FVC) < 70%; post-br FEV1 < 80%pred.
Intervention The investigators will compare the effects of single dose
indacaterol/glycopyrronium 110/50 Breezhaler® versus single dose ipratropium/salbutamol
nebulisation in patients with COPD in stable state
Main study parameters/endpoints:
Area under the curve (AUC) from 0 to 6 hours of FEV1 with indacaterol and glycopyrronium,
compared to nebulisation with ipratropium/salbutamol
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness:
This study has no specific benefits for the participating patients. The study also has no
major risks. Minor risks for participants after a single dosis can be throat irritation,
cough, headache and dizziness, sinus tachycardia. The combination of treatments with
β2-agonist bronchodilators and anticholinergic bronchodilators have been used in daily
practice for many years in many countries and they are often prescribed both in COPD. Both
indacaterol/glycopyrronium and ipratropium/salbutamol are approved for COPD treatment in the
Netherlands