Evidence map›Paper›PMID 30335559›Full record

Trial reportJournal of aerosol medicine and pulmonary drug delivery2019

An Open-Label Study Evaluating the Performance of the Dose Indicator in a Metered Dose Inhaler Delivering Glycopyrrolate and Formoterol Fumarate in Patients with Moderate-to-Very Severe Chronic Obstructive Pulmonary Disease.

Krishna Pudi, Gregory Feldman, Faisal Fakih, Peter Mack, Andrea Maes, Shahid Siddiqui, Earl St Rose, Colin Reisner

Registry-linked trialAbstract readClinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of aerosol medicine and pulmonary drug delivery, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02268396 (An Open-Label, Multi-Center, Dose Indicator Study of Glycopyrronium and Formoterol Fumarate), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT02268396 phase3completednot on this map

An Open-Label, Multi-Center, Dose Indicator Study of Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) in Adult Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

TypeinterventionalSponsorPearl Therapeutics, Inc.Ran2014 to 2015Enrolled138ConditionsCOPDArmsGlycopyrronium and Formoterol Fumarate Metered-dose Inhaler
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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

8 authors.

Krishna Pudi1 Upstate Pharmaceutical Research, Greenville, South Carolina.
Gregory Feldman2 South Carolina Pharmaceutical Research, Spartanburg, South Carolina.
Faisal Fakih3 Florida Premier Research Institute, LLC, Winter Park, Florida.
Peter Mack4 Pearl-a member of the AstraZeneca Group, Durham, North Carolina.
Andrea Maes5 Pearl-a member of the AstraZeneca Group, Morristown, New Jersey.
Shahid Siddiqui6 AstraZeneca, Gaithersburg, Maryland.
Earl St Rose5 Pearl-a member of the AstraZeneca Group, Morristown, New Jersey.
Colin Reisner5 Pearl-a member of the AstraZeneca Group, Morristown, New Jersey.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGFF MDI is a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler formulated using co-suspension delivery technology. This open-label, single-arm multicenter study (NCT02268396) evaluated the accuracy, reliability, and functionality of the GFF MDI AeroCount PATIENTS AND

methodsThe study enrolled subjects (40-80 years of age) with an established clinical history (≥6 months) of COPD, who completed an electronic diary twice daily to record study-drug administration time, the number of actuations used, and pre- and post-dose dose indicator readings. The primary endpoint was the percentage of devices for which the number of subject-reported actuations was consistent (±20 actuations) with the dose indicator-based actuation count (equal to 130 minus the dose indicator reading) at the end of the treatment period (4 weeks). Safety was monitored throughout the study.

resultsA total of 138 subjects with moderate-to-very severe COPD (50.7% male; mean [standard deviation (SD)] age 62.1 [8.3] years) were enrolled and treated. Subject-reported actuation count and dose indicator-based actuation counts were consistent for 96.4% (132/137) of devices at the end of the treatment period (4 weeks) in the intent-to-treat (ITT) population and for all devices in the per-protocol (PP) population. The mean (SD) dose indicator-based actuation and subject-reported actuation counts in the ITT population (n = 137) were 113.4 (18.9) and 117.0 (19.0), respectively, with a mean (SD) difference of 3.6 (7.9). The mean (SD) dose indicator-based actuation and subject-reported actuation counts in the PP population (n = 112) were 116.8 (8.7) and 119.7 (8.1), respectively. There were no unexpected safety findings.

conclusionsThis study supported the accuracy, reliability, and utility of the dose indicator integrated into the GFF MDI device when used by patients with COPD.

Indexed as

Metered Dose InhalersAdministration, InhalationAdrenergic beta-2 Receptor AgonistsAdultAgedAged, 80 and overBronchodilator AgentsDrug CombinationsEquipment DesignFemaleFormoterol FumarateGlycopyrrolateHumansLungMaleMiddle AgedAdrenergic beta-2 Receptor AgonistsBronchodilator AgentsDrug CombinationsFormoterol FumarateGlycopyrrolateMuscarinic Antagonistschronic obstructive pulmonary diseaseco-suspension delivery technologydose indicatorGFF MDI

Identifiers

PMID30335559
PMCPMC6354605

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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.