Evidence map›Paper›PMID 39056534›Full record

Observational studyThe clinical respiratory journal2024

Treatment Adherence and Health Status of Patients With COPD Under Treatment With Salmeterol/Fluticasone via the Elpenhaler® Device: The AHEAD Study.

Konstantinos P Exarchos, Georgios Hillas, Paschalis Steiropoulos, Polyanthi Papanastasiou, Athena Gogali, Konstantinos Kostikas

Abstract readObservational StudyMulticenter Study
In one paragraph

Observational study in The clinical respiratory journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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.

Konstantinos P ExarchosRespiratory Medicine Department, University of Ioannina School of Medicine, Ioannina, Greece.ORCID https://orcid.org/0000-0002-4754-7623
Georgios Hillas5th Pulmonary Department, "Sotiria" Chest Diseases Hospital, Athens, Greece.
Paschalis SteiropoulosDepartment of Respiratory Medicine, Medical School, Democritus University of Thrace, Alexandroupolis, Greece.
Polyanthi PapanastasiouMedical Department, ELPEN Pharmaceutical Co. Inc., Athens, Greece.
Athena GogaliRespiratory Medicine Department, University of Ioannina School of Medicine, Ioannina, Greece.
Konstantinos KostikasRespiratory Medicine Department, University of Ioannina School of Medicine, Ioannina, Greece.

Funding

Elpen Pharmaceutical Co. Inc.
6 · The paper itself

Abstract

backgroundChronic obstructive pulmonary disease (COPD) is a heterogeneous progressive lung condition characterized by long-term respiratory symptoms and airflow limitation. Appropriate bronchodilation is the cornerstone of COPD treatment, leading to better health status as well as benefits in prognosis and mortality.

methodsIn the current open, noninterventional, observational study, 716 patients diagnosed with COPD of variable severity were administered a fixed-dose combination (FDC) of fluticasone propionate and salmeterol (500 + 50 mcg) through the Elpenhaler® device. The patients' adherence to treatment (based on the MMAS-8 [8-item Morisky Medication Adherence Scale]) and health status (based on the CCQ [Clinical COPD Questionnaire]) were assessed at the beginning of the study and at the end of the 3-month follow-up period.

resultsThe mean ± SD MMAS-8 score at 1 and 3 months was 6.12 ± 1.89 and 6.45 ± 1.80, respectively, indicating medium adherence overall; however, there was a statistically significant increase of 0.33 units in the MMAS-8 score at the end of the follow-up (paired t-test p < 0.0001), suggestive of an improvement in adherence throughout the study. Higher adherence was associated with better health status at baseline, which further improved by the end of the follow-up. Moreover, we observed a statistically significant decrease of 1.07 points (p < 0.0001) in the mean CCQ total score from the baseline (CCQ score = 2.2 ± 1.00) until the end of the study follow-up (CCQ score = 1.13 ± 0.67). Similar conclusions were also drawn in the mean domain scores regarding symptoms (score equal to 1.36 ± 0.72, decrease by 1.18) as well as functional and mental state (scores equal to 0.86 ± 0.73 and 1.20 ± 0.88, decrease by 1.04 and 1.00, respectively, p < 0.0001). Similarly, when patients were stratified into subgroups with and without comorbidities, the former group showed an increase of 7% in the patients with medium to high adherence during the course of the study. In the same patient subgroup, there was a notable decrease in CCQ score by 1.18 points (p < 0.0001) during the study.

conclusionsThe administration of FDC of fluticasone propionate and salmeterol, (500 + 50 mcg) via the Elpenhaler® device for COPD, resulted in a well-maintained or slight increase in treatment adherence and a subsequent benefit in health status, which further persisted after 3 months of treatment.

Indexed as

Bronchodilator AgentsDrug MonitoringFluticasone-Salmeterol Drug CombinationHealth StatusPulmonary Disease, Chronic ObstructiveAdministration, InhalationAgedAlbuterolDrug CombinationsFemaleHumansMaleMiddle AgedSurveys and QuestionnairesTreatment OutcomeAlbuterolBronchodilator AgentsDrug CombinationsFluticasone-Salmeterol Drug Combinationadherencechronic obstructive pulmonary diseaseCOPD

Identifiers

PMID39056534
PMCPMC11273290

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.