PMID- 31884206
OWN - NLM
STAT- MEDLINE
DCOM- 20210212
LR  - 20210212
IS  - 1522-9629 (Electronic)
IS  - 1094-5539 (Linking)
VI  - 60
DP  - 2020 Feb
TI  - A long-term clinical trial on the efficacy and safety profile of doxofylline in 
      Asthma: The LESDA study.
PG  - 101883
LID - S1094-5539(19)30277-9 [pii]
LID - 10.1016/j.pupt.2019.101883 [doi]
AB  - Doxofylline, an oral methylxanthine with bronchodilator and anti-inflammatory 
      activities, offers a promising alternative to theophylline due to its superior 
      efficacy/safety profile. No long-term studies on the efficacy and safety of 
      doxofylline are currently available in asthma. The aim of the Long-term clinical 
      trial on the Efficacy and Safety profile of Doxofylline in Asthma (LESDA) 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. The rate of 
      adverse events (AEs) was recorded during the study. Three-hundred nine patients 
      were screened and allocated in the study. Doxofylline significantly improved the 
      change from baseline in forced expiratory volume in 1 s (FEV(1)) (+16.90 +/- 1.81%, 
      P < 0.001 vs. baseline). Doxofylline also significantly improved the rate of 
      asthma events (events/day: -0.57 +/- 0.18, P < 0.05 vs. baseline) and the use of 
      salbutamol as rescue medication (puffs/day: -1.48 +/- 0.25, P < 0.01 vs. baseline). 
      The most common AEs were nausea (14.56%), headache (14.24%), insomnia (10.68%), 
      and dyspepsia (10.03%). There were neither serious AEs nor deaths during or 
      shortly after the study. Concluding, doxofylline is effective and well tolerated 
      when administered chronically in asthmatic patients.
CI  - Copyright (c) 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Calzetta, Luigino
AU  - Calzetta L
AD  - Unit of Respiratory Medicine, Department of Experimental Medicine, University of 
      Rome "Tor Vergata", Rome, Italy. Electronic address: 
      luigino.calzetta@uniroma2.it.
FAU - Matera, Maria Gabriella
AU  - Matera MG
AD  - Unit of Pharmacology, Department of Experimental Medicine, University of Campania 
      "Luigi Vanvitelli", Naples, Italy.
FAU - Goldstein, Marc F
AU  - Goldstein MF
AD  - The Asthma Center, Philadelphia, PA, USA.
FAU - Fairweather, William R
AU  - Fairweather WR
AD  - Flower Valley Consulting, Inc. Rockville, MD, USA.
FAU - Howard, William W
AU  - Howard WW
AD  - Alitair Pharmaceuticals, Inc, Morristown, NJ, USA.
FAU - Cazzola, Mario
AU  - Cazzola M
AD  - Unit of Respiratory Medicine, Department of Experimental Medicine, University of 
      Rome "Tor Vergata", Rome, Italy.
FAU - Rogliani, Paola
AU  - Rogliani P
AD  - Unit of Respiratory Medicine, Department of Experimental Medicine, University of 
      Rome "Tor Vergata", Rome, Italy.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20191226
PL  - England
TA  - Pulm Pharmacol Ther
JT  - Pulmonary pharmacology & therapeutics
JID - 9715279
RN  - 0 (Bronchodilator Agents)
RN  - C137DTR5RG (Theophylline)
RN  - MPM23GMO7Z (doxofylline)
RN  - QF8SVZ843E (Albuterol)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Albuterol
MH  - Asthma/*drug therapy
MH  - Bronchodilator Agents/administration & dosage/*adverse effects/blood/*therapeutic 
      use
MH  - Female
MH  - Forced Expiratory Volume
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Safety
MH  - Theophylline/administration & dosage/adverse effects/*analogs & 
      derivatives/blood/therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Asthma
OT  - Asthma events
OT  - Doxofylline
OT  - Lung function
OT  - Rescue medication
EDAT- 2019/12/31 06:00
MHDA- 2021/02/13 06:00
CRDT- 2019/12/30 06:00
PHST- 2019/11/19 00:00 [received]
PHST- 2019/12/23 00:00 [revised]
PHST- 2019/12/23 00:00 [accepted]
PHST- 2019/12/31 06:00 [pubmed]
PHST- 2021/02/13 06:00 [medline]
PHST- 2019/12/30 06:00 [entrez]
AID - S1094-5539(19)30277-9 [pii]
AID - 10.1016/j.pupt.2019.101883 [doi]
PST - ppublish
SO  - Pulm Pharmacol Ther. 2020 Feb;60:101883. doi: 10.1016/j.pupt.2019.101883. Epub 
      2019 Dec 26.