What is Laventair and what is it used for - umeclidinium bromide, vilanterol?
Laventair is a medicine that contains the active substance umeclidinium bromide and vilanterol . It is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults. COPD is a chronic disease in which the airways and pulmonary alveoli are damaged or blocked, resulting in difficulty breathing. Laventair is used for (regular) maintenance treatment.
How is Laventair used - umeclidinium bromide, vilanterol?
Laventair can only be obtained with a prescription. It is available as an inhalation powder in a portable inhaler. The inhaler delivers 22 micrograms vilanterol and 65 micrograms of umeclidinium bromide (equivalent to 55 micrograms of umeclidium) for each inhalation. The recommended dose is an inhalation once a day, to be taken at the same time. For detailed information on the correct use of the inhaler, see the instructions in the package leaflet.
How does Laventair work - umeclidinium bromide, vilanterol?
Laventair contains two active ingredients: Vilanterol is a long-acting beta2-agonist. It works by binding to beta-2 receptors in the muscles of many organs, including the pulmonary airways. Once inhaled, vilanterol reaches the receptors in the airways and activates them. In this way the airway muscles relax.
Umeclidinium bromide is a muscarinic receptor antagonist. It works by blocking certain receptors called "muscarinic receptors", which control muscle contraction. When Umeclidinium bromide is inhaled, it exerts 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 Laventair - umeclidinium bromide, vilanterol shown during the studies?
The combination of umeclidinium bromide and vilanterol has been analyzed in four main studies involving more than 4700 patients. Two studies compared two fixed dose combinations of umeclidinium bromide and vilanterol (one corresponding to Laventair and one at higher doses) with vilanterol monotherapy, umeclidinium bromide monotherapy and placebo (a dummy treatment). The other two studies compared two fixed dose combinations of umeclidinium bromide and vilanterol with another drug against chronic pulmonary obstructive pulmonary disease (COPD) called tiotropium. The main measure of effectiveness was based on the evolution of the forced expiratory volume (FEV1, the maximum volume of air that a person is able to exhale in one second) of the patient. The results showed that Laventair improved lung function by an average FEV1 of 167 ml more than placebo after 24 weeks of treatment. Laventair also increased FEV1 by an average of 95 ml more than vilanterol alone and 52 ml more than than umeclidinium bromide alone. The average increase in FEV1 with Laventair was 90 ml more than tiotropium after 24 weeks of treatment. Laventair has also been shown to improve symptoms such as short and labored breathing. The results of the combination of higher doses of umeclidinium bromide and vilanterol showed no consistent improvement in lung function.
What is the risk associated with Laventair - umeclidinium bromide, vilanterol?
The most common side effect detected with Laventair (observed in 9 out of 100 patients) is nasopharyngitis (inflammation of the nose and throat). For the full list of side effects and limitations, see the package leaflet.
Why has Laventair been approved - umeclidinium bromide, vilanterol?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Laventair's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that Laventair was effective in improving lung function and COPD symptoms when compared with placebo or single ingredients as well as with tiotropium. The CHMP also noted that there were no safety concerns with Laventair, as the side effects were manageable, although long-term safety data are limited so far.
What measures are being taken to ensure the safe and effective use of Laventair - umeclidinium bromide, vilanterol?
A risk management plan has been developed to ensure that Laventair is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Laventair, including the appropriate precautions to be followed by healthcare professionals and patients.
Since drugs of the same class as Laventair may have effects on the heart and blood vessels in the brain, the company will continue to closely monitor the cardiovascular and cerebral effects of the medicine and will conduct a further long-term study of patients to identify any potential risks. Further information is available in the summary of the risk management plan.
Other information about Laventair - umeclidinium bromide, vilanterol
On 8 May 2014, the European Commission issued a marketing authorization for Laventair, valid throughout the European Union. For more information about treatment with Laventair, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 05/2014.
