Evidence map›Paper›PMID 23557023›Full record

Trial reportBMC pulmonary medicine2013

Real-life effectiveness of budesonide/formoterol maintenance and reliever therapy in asthma patients across Asia: SMARTASIA study.

Nanshan Zhong, Jiangtao Lin, Parthiv Mehta, Pintip Ngamjanyaporn, Tzu-Chin Wu, Faisal Yunus

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IVMulticenter Study
In one paragraph

Trial report in BMC pulmonary medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00939341 phase4completednot on this map

Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy (SMART) in Asthma Patients Across Asia: SMARTASIA

TypeinterventionalSponsorAstraZenecaRan2009 to 2010Enrolled862ConditionsAsthmaArmsSymbicort (Budesonide/Formoterol)
NCT04835961 completednot on this mapstarted 2021, after this paper: background citation

This Study Will Record the Use of Budesonide / Formoterol Either as Maintenance Treatment or / or as Needed According to Standard Clinical Practice and at the Discretion of the Treating Physician.

TypeobservationalSponsorElpen Pharmaceutical Co. Inc.Ran2021 to 2022Enrolled1,037ConditionsAsthmaArmsMaintenace and As needed
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Overprescription of short-acting β2 agonists: reflections from the SABINA study in Brazil.Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia · 2024
    Observational
  3. Observational
  4. Article
  5. The effect ofExperimental and therapeutic medicine · 2018
    Article
  6. Article
  7. Article
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 6 institutions in 5 countries.

Nanshan ZhongRespiratory Research Institute, 1st Affiliated Hospital of Guangzhou Medical College, Guangzhou, China. nanshan@vip.163.com
Jiangtao Lin
Parthiv Mehta
Pintip Ngamjanyaporn
Tzu-Chin Wu
Faisal Yunus
China-Japan Friendship Hospital · CNChung Shan Medical University Hospital · TWDr. Mehta's Children's Hospital · INMahidol University · THState Key Laboratory of Respiratory Disease · CNUniversity of Indonesia · ID

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe use of budesonide/formoterol in a single inhaler for both maintenance and reliever therapy is a recommended option for treatment of persistent asthma not responding well to inhaled corticosteroid (ICS) alone.

methodsThis was a multi-centre open-label study on patients whose asthma condition remained inadequately controlled by various asthma treatments other than budesonide/formoterol. After a 2-week run-in period, eligible patients underwent a 12-week treatment period with budesonide/formoterol (Symbicort SMART(®), 160/4.5 μg) twice daily plus as needed. Patient's asthma control and quality of life were assessed using the 5-item Asthma Control Questionnaire (ACQ-5) and the standardized Asthma Quality of Life Questionnaire (AQLQ-S), respectively.

resultsA total of 862 eligible asthma patients who have had asthma for a mean duration of 10.73 ± 12.03 years entered a 12-week treatment with budesonide/formoterol maintenance and reliever therapy. During treatment, ACQ-5 score improved significantly by 0.58 ± 0.93 (95% CI, 0.51 to 0.64, P < 0.0001) from the baseline level of 1.62 ± 1.00. AQLQ(S) score improved by 0.70 ± 0.89 (95% CI, 0.64 to 0.76, P < 0.0001) from baseline. Asthma symptom score was also reduced significantly (P < 0.0001); between run-in and treatment periods, night- and day-time symptom scores were reduced by 0.32 ± 0.54 (95% CI, 0.28 to 0.35) and 0.30 ± 0.52 (95% CI, 0.27 to 0.34), respectively. The percentage of nights with awakenings due to asthma symptoms was reduced by 11.09 ± 26.13% (95% CI, 9.34 to 12.85%), while the percentage of asthma-control and symptom-free days increased by 20.90 ± 34.40% (95% CI, 18.59 to 23.21%) and 23.89 ± 34.62% (95% CI, 21.56 to 26.21%), respectively (P < 0.0001). Together with the improvement in asthma control, the number of night- and day-time inhalations of as-needed reliever medication decreased by 0.30 ± 0.82 (95% CI, 0.24 to 0.35) inhalations and 0.30 ± 0.97 (95% CI, 0.23 to 0.36) inhalations, respectively (P < 0.0001). No unexpected adverse events were reported.

conclusionDuring treatment of inadequately controlled asthmatic patients with budesonide/formoterol maintenance and reliever therapy, significant improvement in patients' asthma control and reductions in asthma symptoms and as-needed medication use was observed. Patients' quality of life was improved and the treatment was well tolerated.

trial registrationClinicalTrial.gov: (NCT00939341).

Indexed as

AdultAsiaAsthmaBronchodilator AgentsBudesonideEthanolaminesFemaleForced Expiratory VolumeFormoterol FumarateHumansMaleMiddle AgedQuality of LifeSleepSurveys and QuestionnairesTreatment OutcomeBronchodilator AgentsBudesonideEthanolaminesFormoterol Fumarate

Identifiers

PMID23557023
PMCPMC3637584
OpenAlexW2055324311

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.