Evidence map›Paper›PMID 29713156›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease

Indacaterol/glycopyrronium reduces the risk of clinically important deterioration after direct switch from baseline therapies in patients with moderate COPD: a post hoc analysis of the CRYSTAL study.

Timm Greulich, Konstantinos Kostikas, Mina Gaga, Maryam Aalamian-Mattheis, Nadine S Lossi, Francesco Patalano, Xavier Nunez, Veronica A Pagano, Robert Fogel, Claus F Vogelmeier and 1 more

Open access · goldAbstract readMulticenter 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. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
2.7field-weighted citation impact, top 9% 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

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Early Clinically Important Improvement (ECII) and Exacerbation Outcomes in COPD Patients.International journal of chronic obstructive pulmonary disease · 2020
    Trial
  5. Trial
  6. Article
  7. Observational
  8. Step-Up and Step-Down Treatment Approaches for COPD: A Holistic View of Progressive Therapies.International journal of chronic obstructive pulmonary disease · 2021
    Review
  9. Review
  10. Observational
  11. 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

11 authors at 6 institutions in 5 countries.

Timm GreulichUniversity Medical Center Giessen and Marburg, German Center for Lung Research (DZL), Marburg, Germany.
Konstantinos KostikasNovartis Pharma AG, Basel, Switzerland.
Mina Gaga7th Respiratory Medicine Department, Athens Chest Hospital Sotiria, Athens, Greece.
Maryam Aalamian-MattheisNovartis Pharma AG, Basel, Switzerland.
Nadine S LossiNovartis Pharma GmbH, Nürnberg, Germany.
Francesco PatalanoNovartis Pharma AG, Basel, Switzerland.
Xavier NunezTFS Develop, Barcelona, Spain.
Veronica A PaganoTFS Develop, Barcelona, Spain.
Robert FogelNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Claus F Vogelmeier *University Medical Center Giessen and Marburg, German Center for Lung Research (DZL), Marburg, Germany.
Andreas Clemens *Novartis Pharma AG, Basel, Switzerland.
Novartis (Switzerland) · CHTeulades i Façanes Multifuncionals (Spain) · ESUniversities of Giessen and Marburg Lung Center · DENovartis (Germany) · DENovartis (United States) · USSotiria General Hospital · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeCOPD is a progressive disease characterized by exacerbations and a decline in health status and lung function. Clinically important deterioration (CID) is a composite endpoint used to evaluate treatment efficacy. This analysis evaluated the impact of a direct switch to once-daily indacaterol/glycopyrronium 110/50 µg (IND/GLY) from previous monotherapy with a long-acting β

methodsCRYSTAL was a 12-week, prospective, multicenter, randomized, open-label study conducted in clinical practice settings. Three definitions of CID (D1-D3) were used, including: 1) ≥100 mL decrease in trough forced expiratory volume in 1 second (FEV

resultsOf the 2,159 patients analyzed, 1,622 switched to IND/GLY and 537 continued their baseline treatments. The percentage of patients with a CID was significantly lower after a direct switch to IND/GLY versus LABA or LAMA using all 3 CID definitions (D1: odds ratio [OR] 0.41 [95% CI: 0.30-0.55]; D2: OR 0.41 [95% CI: 0.31-0.55]; D3: OR 0.39 [95% CI: 0.29-0.52]). Compared with LABA + ICS, IND/GLY also reduced the risk of CID (D1: OR 0.76 [95% CI: 0.56-1.02]; D2: OR 0.75 [95% CI: 0.56-1.00]; D3: OR 0.67 [95% CI: 0.51-0.89]).

conclusionIn this analysis, IND/GLY reduced the risk of a CID in moderate COPD patients after direct switch from LABA + ICS or LABA or LAMA in real-life clinical practice.

Indexed as

Drug SubstitutionAdministration, InhalationAdrenal Cortex HormonesAdrenergic beta-2 Receptor AgonistsAgedBronchodilator AgentsDisease ProgressionDrug CombinationsEuropeFemaleForced Expiratory VolumeGlycopyrrolateHealth StatusHumansIndansLungAdrenal Cortex HormonesAdrenergic beta-2 Receptor AgonistsBronchodilator AgentsDrug CombinationsGlycopyrrolateindacaterol-glycopyrronium combinationIndansMuscarinic AntagonistsQuinolonesclinical COPD questionnaire/CCQclinically important deterioration/CIDdirect-switchopen-labelpragmatictransition dyspnea index/TDI

Identifiers

PMID29713156
PMCPMC5909796
OpenAlexW2797389618

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.