Evidence map›Paper›PMID 28720132›Full record

Trial reportRespiratory research2017

Efficacy and safety of direct switch to indacaterol/glycopyrronium in patients with moderate COPD: the CRYSTAL open-label randomised trial.

Claus F Vogelmeier, Mina Gaga, Maryam Aalamian-Mattheis, Timm Greulich, Jose M Marin, Walter Castellani, Vincent Ninane, Stephen Lane, Xavier Nunez, Francesco Patalano and 3 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Respiratory research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01985334 (A Prospective, Multicenter, 12-week, Randomized Open-label Study to Evaluate the Efficacy and Safety of Glycopyrronium), which is not on this map. Cited by 28 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 5 pooled it
8.0field-weighted citation impact, top 2% 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.

NCT01985334 phase4completednot on this map

A Prospective, Multicenter, 12-week, Randomized Open-label Study to Evaluate the Efficacy and Safety of Glycopyrronium (50 Micrograms o.d.) or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination (110/50 Micrograms o.d.) Regarding Symptoms and Health Status in Patients With Moderate Chronic Obstructive Pulmonary Disease (COPD) Switching From Treatment With Any Standard COPD Regimen

TypeinterventionalSponsorNovartis PharmaceuticalsRan2014 to 2016Enrolled4,389ConditionsCOPDArmsGlycopyrronium, SABA, LABA, Indacaterol maleate and glycopyrronium bromide, LAMA
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 5 syntheses or guidelines pooled it, 54 citations in OpenAlex.

  1. Pooled it
  2. Race-Based Pulmonary Function Testing Correction in COPD Inhaler Therapy Trials: A Systematic Review.International journal of chronic obstructive pulmonary disease · 2024
    Pooled it
  3. Pooled it
  4. Pooled it
  5. LABA/LAMA fixed-dose combinations in patients with COPD: a systematic review.International journal of chronic obstructive pulmonary disease
    Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Observational
  11. Article
  12. Article
  13. Article
  14. Time to Prescribe Dual instead of Mono.Tuberculosis and respiratory diseases · 2021
    Article
  15. Article
  16. Observational
  17. Review
  18. Observational
  19. Treatment response in COPD: does FEVERJ open research · 2019
    Article
  20. Withdrawal of inhaled corticosteroids in COPD patients: rationale and algorithms.International journal of chronic obstructive pulmonary disease · 2019
    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

13 authors at 5 institutions in 6 countries.

Claus F VogelmeierDepartment of Medicine, Pulmonary and Critical Care Medicine, University Medical Centre Giessen and Marburg, Philipps-Universität Marburg, Member of the German Centre for Lung Research (DZL), Marburg, Germany. claus.vogelmeier@med.uni-marburg.de.
Mina Gaga7th Respiratory Medicine Department, Athens Chest Hospital Sotiria, Athens, Greece.
Maryam Aalamian-MattheisNovartis Pharma AG, Basel, Switzerland.
Timm GreulichDepartment of Medicine, Pulmonary and Critical Care Medicine, University Medical Centre Giessen and Marburg, Philipps-Universität Marburg, Member of the German Centre for Lung Research (DZL), Marburg, Germany.
Jose M MarinRespiratory Medicine, Hospital Universitario Miguel Servet, Zaragoza, Spain.
Walter CastellaniDepartment of Respiratory Physiopathology, Palagi Hospital, Florence, Italy.
Vincent NinaneCHU Saint-Pierre - Service de Pneumologie, Brussells, Belgium.
Stephen LaneAdelaide & Meath Hospital, Dublin, Ireland.
Xavier NunezTFS Develop, Barcelona, Spain.
Francesco PatalanoNovartis Pharma AG, Basel, Switzerland.
Andreas ClemensNovartis Pharma AG, Basel, Switzerland.
Konstantinos KostikasNovartis Pharma AG, Basel, Switzerland.
CRYSTAL study investigators
Novartis (Switzerland) · CHPhilipps University of Marburg · DETallaght University Hospital · IECentre Hospitalier Universitaire de Saint-Pierre · BECentro de Investigación Biomédica en Red de Enfermedades Respiratorias · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDual bronchodilation combining a long-acting β

methodsThe CRYSTAL study was the first, 12-week, randomised, open-label trial that evaluated the efficacy and safety of a direct switch from previous treatments to IND/GLY 110/50 μg q.d. on lung function and dyspnoea in patients with moderate COPD and a history of up to one exacerbation in the previous year. Patients were divided into 2 groups according to their background therapy and symptom scores and were randomised (3:1) to IND/GLY or to continue with their previous treatments.

resultsThe study included 4389 randomised patients, of whom 2160 were in groups switched to IND/GLY (intention-to-treat population). The effect of IND/GLY was superior to LABA + ICS on trough forced expiratory volume in 1 s (FEV

conclusionsIND/GLY demonstrated superior improvements in lung function and dyspnoea after direct switch from previous treatments.

trial registrationClinicalTrials.gov number: NCT01985334 .

Indexed as

Drug SubstitutionAdrenergic beta-2 Receptor AgonistsAdultAgedBronchodilator AgentsDisease ProgressionDrug CombinationsDyspneaEuropeFemaleForced Expiratory VolumeGlycopyrrolateHealth StatusHumansIndansLungAdrenergic beta-2 Receptor AgonistsBronchodilator AgentsDrug CombinationsGlycopyrrolateindacaterol-glycopyrronium combinationIndansMuscarinic AntagonistsQuinolonesChronic obstructive pulmonary diseaseDirect switchDual bronchodilationIndacaterol/glycopyrroniumOpen-label

Identifiers

PMID28720132
PMCPMC5516383
OpenAlexW2738246554

What OpenQuestion holds

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Read underepoch 390

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.