PMID- 31213944
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200929
IS  - 1179-7266 (Print)
IS  - 1179-7266 (Electronic)
IS  - 1179-7266 (Linking)
VI  - 10
DP  - 2019
TI  - A multicenter, open-label, noninterventional study to evaluate the impact on 
      clinical effects, user-friendliness and patients' acceptance of AirFluSal 
      Forspiro in the treatment of asthma under real-life conditions (ASSURE).
PG  - 29-39
LID - 10.2147/POR.S200654 [doi]
AB  - Background: The design of inhaler devices may potentially influence 
      adherence/persistence and outcomes in asthma. Objective: The primary objective 
      was to assess asthma control and any change in the quality of life in patients 
      using an intuitive dry powder inhaler containing fluticasone 
      propionate/salmeterol (AirFluSal((R)) Forspiro((R))) for the treatment of asthma in 
      everyday practice. Methods: ASSURE was a multicenter, noninterventional, 
      open-label, prospective study in patients with asthma, aged >/=12 years and treated 
      with the Forspiro device in Denmark, Sweden and Norway. Patients' opinions of 
      their asthma control were assessed by the Asthma Control Test (ACT) questionnaire 
      and asthma-related quality of life by the Mini Asthma Quality of Life 
      Questionnaire (miniAQLQ) at baseline and at two follow-up visits (approximately 
      4-8-week intervals). Results: Of 321 patients enrolled in the study, 299 received 
      at least one dose of fluticasone propionate/salmeterol via the Forspiro device 
      and 204 had evaluable data at the baseline visit and at least one later visit. 
      Patients showed improvements in asthma control and quality of life during the 
      study. The mean sum score of ACT increased from 18.0 (SD 4.5) at visit 1 to 19.9 
      (4.2) at visit 2 and 20.5 (4.3) at visit 3. Overall, 38.2% of patients improved 
      by the minimal clinically important difference (MCID) of >/=3 points (45.6% among 
      those with a baseline score below 23 [ie, not already well controlled]). The mean 
      score on the miniAQLQ increased from 5.16 (SD 1.24) at visit 1 to 5.58 (SD 1.20) 
      at visit 2 and 5.82 (SD 1.04) at visit 3. Overall, 42.6% of patients improved by 
      the MCID of >/=0.5. Conclusion: This real-life study suggests that treatment with 
      fluticasone propionate/salmeterol via the Forspiro device can improve asthma 
      symptom control and quality of life.
FAU - Backer, Vibeke
AU  - Backer V
AD  - Department of Respiratory Medicine, Bispebjerg Hospital, Copenhagen University, 
      48 2400 Copenhagen, Denmark.
FAU - Bjermer, Leif
AU  - Bjermer L
AD  - Department of Respiratory Medicine and Allergology, Skane University Hospital, 
      221 85 Lund, Sweden.
FAU - Refvem, Olav Kare
AU  - Refvem OK
AD  - Lungepraksis AS, Oslo 0873, Norway.
FAU - Soderman, Andreas
AU  - Soderman A
AD  - Medical Affairs Nordics, Sandoz AS, Copenhagen, DK-2300, Denmark.
FAU - Jones, Spencer
AU  - Jones S
AD  - Global Medical Affairs, Sandoz International GmbH, Holzkirchen, D-83607, Germany.
LA  - eng
PT  - Journal Article
DEP - 20190524
PL  - New Zealand
TA  - Pragmat Obs Res
JT  - Pragmatic and observational research
JID - 101688693
PMC - PMC6541794
OTO - NOTNLM
OT  - asthma
OT  - fluticasone propionate
OT  - quality of life
OT  - salmeterol
OT  - symptom control
COIS- Andreas Soderman is an employee of Sandoz AS. Spencer Jones is an employee of 
      Sandoz International GmbH and holds stock in Novartis. Leif Bjermer reports 
      honoraria from ALK, Airsonette, AstraZeneca, Boehringer, Chiesi, GlaxoSmithKline, 
      Novartis, Teva, outside the submitted work. Olav Kare Refvem reports personal 
      fees from Boehringer-Ingelheim, outside the submitted work, and is the owner of 
      Lungepraksis AS. The authors report no other conflicts of interest in this work.
EDAT- 2019/06/20 06:00
MHDA- 2019/06/20 06:01
PMCR- 2019/05/24
CRDT- 2019/06/20 06:00
PHST- 2019/01/09 00:00 [received]
PHST- 2019/04/12 00:00 [accepted]
PHST- 2019/06/20 06:00 [entrez]
PHST- 2019/06/20 06:00 [pubmed]
PHST- 2019/06/20 06:01 [medline]
PHST- 2019/05/24 00:00 [pmc-release]
AID - 200654 [pii]
AID - 10.2147/POR.S200654 [doi]
PST - epublish
SO  - Pragmat Obs Res. 2019 May 24;10:29-39. doi: 10.2147/POR.S200654. eCollection 
      2019.