What is it?

Oslif Breezhaler is a medicine that contains the active substance indacaterol. It is available as capsules containing a powder for inhalation (150 and 300 micrograms).

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Oslif Breezhaler is used to keep the airways open in adults with chronic obstructive pulmonary disease (COPD). COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing air in and out of the lungs.
The medicine can only be obtained with a prescription.

How is it used?

Oslif Breezhaler capsules are only used with an Oslif Breezhaler inhaler and must not be swallowed. To take a dose, the patient places a capsule into the inhaler and breathes the powder in through the mouth.
The recommended dose is one 150-microgram capsule, once a day at the same time each day. A dose of one 300-microgram capsule may be used in cases of severe COPD, but this must only be done on the doctor?s instructions.

How does it work?

The active substance in Oslif Breezhaler, indacaterol, is a beta-2 adrenergic receptor agonist. It works by attaching to beta-2 receptors that are found in the muscle cells of many organs and that cause the muscles to relax. When Oslif Breezhaler is inhaled, indacaterol reaches the receptors in the airways and activates them. This causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily.

How has it been studied?

The effects of Oslif Breezhaler were first tested in experimental models before being studied in humans.
In three main studies involving over 4,000 patients with COPD, Oslif Breezhaler at different doses has been compared with placebo (a dummy treatment), tiotropium or formoterol (other inhaled medicines used to treat COPD). The main measure of effectiveness was how Oslif Breezhaler compared with placebo in improving patients? forced expiratory volumes (FEV1) after 12 weeks. FEV1 is the most air a person can breathe out in one second.

What benefits has it shown during the studies?

Oslif Breezhaler was more effective than placebo at improving how well the lungs work in patients with COPD. On average, the improvement in FEV1 in patients who received Oslif Breezhaler was between 150 to 190 ml, while for patients who received placebo the change in FEV1 ranged from a decrease of 10 ml to an increase of 20 ml. Overall, the effects of the 150- and 300-microgram doses of Oslif Breezhaler were similar, but the results showed that the 300-microgram dose may provide better relief in patients with more severe disease.

What is the risk associated?

The most common side effects with Oslif Breezhaler (seen in between 1 and 10 patients in 100) are nasopharyngitis (inflammation of the nose and throat), upper respiratory tract infection (colds), sinusitis (inflammation of the sinuses), diabetes mellitus and hyperglycaemia (high blood sugar levels), headache, ischaemic heart disease (disease of the heart caused by failure in the blood supply), cough, pharyngolaryngeal (throat) pain, rhinorrhoea (runny nose), respiratory tract congestion (blocked airways), muscle spasm (cramps) and peripheral oedema (swelling, especially of the ankles and feet). For the full list of all side effects reported with Oslif Breezhaler, see the Package Leaflet. Oslif Breezhaler should not be used in people who may be hypersensitive (allergic) to indacaterol, lactose or any of the other ingredients.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Oslif Breezhaler?s benefits are greater than its risks and recommended that Oslif Breezhaler be given marketing authorisation.

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