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Ultibro Breezhaler (indacaterol/glycopyrronium)


Ultibro Breezhaler combines two well-known drugs: indacaterol (LABA) and glycopyrronium (LAMA). The indication is bronchodilating maintenance treatment to relieve symptoms in adult patients with COPD. 


The combination product's improvement of the lung function (FEV1) was markedly more effective than placebo, but on level with and not better than the individual components alone, although more patients respond to the combination therapy (NNT of around 5). The combination does not significantly reduce the incidence of moderate to severe exacerbations compared with glycopyrronium or tiotropium alone. No studies have been conducted demonstrating the compliance or safety benefits of combination therapy over the use of both drugs in a monotherapy inhaler. The most frequent adverse events include nasopharyngitis and cough.


If double-therapy bronchodilatator treatment is indicated, it is IRF's overall assessment that Ultibro Breezhaler can be considered, but the drug does not provide any clinically relevant benefits over the use of both drugs in a monotherapy inhaler. Thus, COPD patients should be treated with the cheapest drug analogues in the cheapest inhalation system.


Ultibro Breezhaler was marketed on 25 November 2013 and general reimbursement is currently granted.


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