Evidence map›Paper›PMID 34322547›Full record

ArticleERJ open research2021

Efficacy and safety of single-inhaler triple therapy of glycopyrronium, formoterol and fluticasone in patients with COPD: a double-blind, randomised controlled trial.

Sundeep Salvi, Akash Balki, Srikanth Krishnamurthy, Sagar Panchal, Saiprasad Patil, Rahul Kodgule, Hitesh Khandagale, Amol Pendse, Wen Wu, Shabbir Rangwala and 2 more

Open access · goldAbstract read
In one paragraph

Article in ERJ open research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 14% 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.

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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Clinical Concepts for Triple Therapy Use in Patients with COPD: A Delphi Consensus.International journal of chronic obstructive pulmonary disease · 2023
    Article
  4. Article
  5. 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

12 authors at 2 institutions in 1 country.

Sundeep SalviChest Research Foundation, Pune, India.
Akash BalkiShree Hospital and Critical Care Center, Nagpur, India.
Srikanth KrishnamurthySri Bala Medical Centre and Hospital, Coimbatore, India.
Sagar PanchalGlobal Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, India.
Saiprasad PatilGlobal Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, India.
Rahul KodguleClinical Development, Glenmark Pharmaceuticals Ltd, Mumbai, India.
Hitesh KhandagaleClinical Research Operations, Glenmark Pharmaceuticals Ltd, Mumbai, India.
Amol PendseClinical Research Operations, Glenmark Pharmaceuticals Ltd, Mumbai, India.
Wen WuClinical Operations, Glenmark Pharmaceuticals Ltd, Waterford, UK.
Shabbir RangwalaClinical Research Operations, Glenmark Pharmaceuticals Ltd, Mumbai, India.
Monika TandonClinical Development, Glenmark Pharmaceuticals Ltd, Mumbai, India.
Hanmant BarkateGlobal Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, India.
Glenmark Pharmaceuticals (India) · INShree Krishna Hospital · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe aim of this work was to investigate the safety and efficacy of single-inhaler triple therapy with 12.5 μg glycopyrronium (GB)/12 μg formoterol fumarate (FF)/250 μg fluticasone propionate (FP), compared to 50 μg GB co-administered with a fixed dose of 12 μg FF/250 μg FP in subjects with COPD.

methodsThis was a phase 3, randomised, double-blind, active-control, parallel-group, noninferiority study conducted at 20 sites across India. COPD patients aged ≥40 to ≤75 years, with forced expiratory volume in 1 s (FEV

resultsBetween 23 March 2019 and 14 February 2020, 396 subjects were enrolled, with 198 patients each in the fixed-triple (GB/FF/FP) and open-triple (GB+FF/FP) groups. The difference in least-square mean (LSM) changes in pre-dose FEV

conclusionsFixed triple therapy with GB/FF/FP provides comparable bronchodilation and lung function improvement as open-triple therapy. It is safe and well tolerated in symptomatic COPD patients with a history of exacerbations.

Identifiers

PMID34322547
PMCPMC8311133
OpenAlexW3168208924

What OpenQuestion holds

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LicenceCC BY-NC
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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.