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LESDA, a long-term clinical trial on the efficacy and safety profile of Doxofylline in asthma


Doxofylline ( Ansimar ), an oral methylxanthine with bronchodilator and anti-inflammatory activities, offers a promising alternative to Theophylline due to its superior efficacy / safety profile.

The aim of LESDA ( Long-term clinical trial on the Efficacy and Safety profile of Doxofylline in Asthma ) study was to investigate the safety and efficacy profile of Doxofylline administered for one year in asthmatic patients.

LESDA was a multicenter, open-label, phase III, clinical trial in which adult asthmatic patients received the same treatment ( oral Doxofylline 400 mg t.i.d. ) for one year.

Efficacy was assessed through periodic pulmonary function tests and by having the subjects keep monthly records of asthma events rates and use of Salbutamol as rescue medication.

Three-hundred nine patients were screened and allocated in the study.

Doxofylline has significantly improved the change from baseline in forced expiratory volume in 1 s ( FEV1 ) ( +16.90 ± 1.81%, P less than 0.001 versus baseline ).

Doxofylline has also significantly improved the rate of asthma events ( events/day: -0.57 ± 0.18, P less than 0.05 vs baseline ) and the use of Salbutamol as rescue medication ( puffs/day: -1.48 ± 0.25, P less than 0.01 vs baseline ).

The most common adverse effects were nausea ( 14.56% ), headache ( 14.24% ), insomnia ( 10.68% ), and dyspepsia ( 10.03% ).
There were neither serious adverse reactions nor deaths during or shortly after the study.

In conclusion, Doxofylline is effective and well tolerated when administered chronically in asthmatic patients. ( Xagena )

Calzetta L et al, Pulm Pharmacol Ther 2020;60:101883. doi: 10.1016/j.pupt.2019.101883.

XagenaMedicine_2020



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