What is Ultibro Breezhaler and what is it used for: indacaterol and glycopyrronium?
Ultibro Breezhaler is a medicine containing two active substances, indacaterol (85 micrograms) and glycopyrronium (43 micrograms). It is used as a (regular) maintenance therapy to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). COPD is a chronic disease in which the airways and pulmonary alveoli are damaged or blocked, resulting in difficulty in inhaling and exhaling air from the lungs.
How is Ultibro Breezhaler used - indacaterol and glycopyrronium?
Ultibro Breezhaler is available as a capsule containing a powder for inhalation and can only be obtained with a prescription. The recommended dose is the inhalation of the content of one capsule once a day. The medicine should be taken at the same time each day, using the Ultibro Breezhaler inhaler. The contents of the capsules must not be inhaled using another device. In patients with severely impaired renal function, Ultibro Breezhaler should only be used after a careful risk-benefit assessment.
How does Ultibro Breezhaler work - indacaterol and glycopyrronium?
The active ingredients present in Ultibro Breezhaler, indacaterol and glycopyrronium, act differently to dilate the airways and improve breathing in COPD. Indacaterol is a long-acting beta-2 agonist. It works by binding to beta-2 adrenergic receptors in the musculature of many organs, including the pulmonary airways. Once inhaled, indacaterol reaches the receptors in the airways and activates them. In this way the airway muscles relax. Glycopyrronium is a muscarinic receptor antagonist. It works by blocking certain receptors called "muscarinic receptors", which control muscle contraction. When inhaled, glycopyrronium has a relaxing effect on the airway muscles. The combined action of the two active ingredients helps keep the airways dilated and allows the patient to breathe more easily. Muscarinic receptor antagonists and long-acting beta-2-adrenergic agonists are usually combined in the treatment of COPD.
What benefit has Ultibro Breezhaler - indacaterol and glycopyrronium shown during the studies?
Ultibro Breezhaler was studied in two main studies involving a total of 2, 667 patients with COPD. One study compared the effects of Ultibro Breezhaler with those of a placebo (an ineffective inhalation on the body) or indacaterol or glycopyrronium monotherapy, while the second study compared Ultibro Breezhaler with fluticasone and salmeterol, a standard treatment for COPD. In both studies, the main measure of effectiveness was the improvement in forced expiratory volume (FEV1, the maximum volume of air a person can exhale in one second) of patients treated with Ultibro Breezhaler after 26 weeks of therapy. The first study showed that treatment with Ultibro Breezhaler was more effective than placebo and, on average, increased FEV1 by 200 ml more. In addition, Ultibro Breezhaler increased FEV1 by 70 ml more than indacaterol taken on its own and 90 ml more than glycopyrronium taken on its own. In the second study, FEV1 increased on average 140 ml more with Ultibro Breezhaler than therapy with fluticasone and salmeterol. A third study examined the effects of Ultibro Breezhaler on the percentage of exacerbations of symptoms recorded over 64 weeks of treatment compared to glycopyrronium or tiotropium therapy (other treatments of COPD). The reduction in the percentage of exacerbations was 10 to 12% higher with Ultibro Breezhaler than with tiotropium and glycopyrronium.
What is the risk associated with Ultibro Breezhaler - indacaterol and glycopyrronium?
The most common side effects with Ultibro Breezhaler (which may affect more than 1 in 10 people) are upper respiratory tract infections (colds). For the full list of all side effects reported with Ultibro Breezhaler, see the package leaflet.
Why has Ultibro Breezhaler - indacaterol and glycopyrronium - been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ultibro Breezhaler's benefits are greater than its risks and recommended that it be approved for use in the EU. The effects of Ultibro Breezhaler administered to alleviate COPD symptoms have been clinically significant. However, the CHMP considered that its effects on reducing the percentage of exacerbations were too limited to recommend the use of medicines in the reduction of exacerbations. As for safety, Ultibro Breezhaler is comparable to indacaterol and glycopyrronium used as monotherapy. The side effects observed in the studies were generally benign and are considered manageable.
What measures are being taken to ensure the safe and effective use of Ultibro Breezhaler - indacaterol and glycopyrronium?
A risk management plan has been developed to ensure that Ultibro Breezhaler is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the information leaflet for Ultibro Breezhaler, including the appropriate precautions to be followed by healthcare professionals and patients.
More information on Ultibro Breezhaler - indacaterol and glycopyrronium
On 19 September 2013, the European Commission issued a marketing authorization for Ultibro Breezhaler, valid throughout the European Union. For more information about treatment with Ultibro Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 09-2013.
