Evidence map›Paper›PMID 33692621›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease

The Impact of Budesonide/Formoterol pMDI Medication Reminders on Adherence in Chronic Obstructive Pulmonary Disease (COPD) Patients: Results of a Randomized, Phase 4, Clinical Study.

Gerard J Criner, Therese Cole, Kristen A Hahn, Kari Kastango, James Eudicone, Ileen Gilbert

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02864342 (A Randomized Clinical Study to Assess the Impact of Symbicort® pMDI Medication Reminders on Adherence in COPD Patients), which is not on this map. Cited by 16 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 6 pooled it
3.1field-weighted citation impact, top 8% 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.

NCT02864342 phase4completednot on this map

A Randomized Clinical Study to Assess the Impact of Symbicort® pMDI Medication Reminders on Adherence in COPD Patients

TypeinterventionalSponsorAstraZenecaRan2016 to 2017Enrolled138ConditionsChronic Obstructive Pulmonary Disease (COPDArmsArm 1: BreatheMate device with application, Arm 2: BreatheMate device without application
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 6 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Digital remote maintenance inhaler adherence interventions in COPD: a systematic review and meta-analysis.European respiratory review : an official journal of the European Respiratory Society · 2024
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Article
  8. Article
  9. Review
  10. Article
  11. Inhaler Adherence in COPD: A Crucial Step Towards the Correct Treatment.International journal of chronic obstructive pulmonary disease · 2023
    Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. 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 3 institutions in 1 country.

Gerard J CrinerDepartment of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University Hospital, Philadelphia, PA, USA.
Therese ColeIQVIA, Rockville, MD, USA.
Kristen A HahnIQVIA, Cambridge, MA, USA.
Kari KastangoIQVIA, Cambridge, MA, USA.
James EudiconeAstraZeneca, Wilmington, DE, USA.ORCID 0000-0001-7020-2490
Ileen GilbertAstraZeneca, Wilmington, DE, USA.ORCID 0000-0003-3529-0186
IQVIA (United States) · USAstraZeneca (United States) · USTemple University Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAmong patients with chronic obstructive pulmonary disease (COPD), adherence to inhaled medication leads to fewer exacerbations and improved health status. The goal of the present study was to evaluate the effects of medication reminders via the BreatheMate device on adherence in patients with COPD. PATIENTS AND

methodsA 6-month, phase 4, randomized, multicenter, open-label US study (NCT02864342) enrolled 138 patients aged ≥40 years with moderate to very severe COPD and ≥10 pack-year smoking history. Patients in the intervention (n = 68) and control (n = 70) groups received the BreatheMate device, smartphone application, and vouchers to redeem pressurized metered-dose inhalers (pMDIs) for the prescribed 2 puffs of budesonide/formoterol 160/4.5 μg twice daily. The intervention group also received twice-daily electronic reminders to take budesonide/formoterol. The primary endpoint was the mean number of sets of adherent puffs/day (4 puffs: 2 puffs within 60 minutes, twice daily) over 6 months. Secondary endpoints included adherence by three 60-day intervals, usage days, prescription refills, and Clinical COPD Questionnaire (CCQ) score. Study enrollment terminated early due to issues with inconsistent syncing.

resultsA higher mean proportion of adherent days (77.6% vs 60.2%;

conclusionMedication reminders through the BreatheMate device and application produced greater adherence to inhaled therapy in patients with COPD.

Indexed as

Pulmonary Disease, Chronic ObstructiveAdministration, InhalationAdultAgedAged, 80 and overBronchodilator AgentsBudesonideDouble-Blind MethodDrug CombinationsEthanolaminesFemaleForced Expiratory VolumeFormoterol FumarateHumansMaleMetered Dose InhalersBronchodilator AgentsBudesonideDrug CombinationsEthanolaminesFormoterol Fumarateadherencechronic obstructive pulmonary diseasepressurized metered-dose inhalertelemedicine

Identifiers

PMID33692621
PMCPMC7939512
OpenAlexW3135336659

What OpenQuestion holds

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LicenceCC BY-NC
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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.