Evidence map›Paper›PMID 25231008›Full record

Trial reportPharmaceutical research2015

Prediction of disease progression, treatment response and dropout in chronic obstructive pulmonary disease (COPD).

F T Musuamba, D Teutonico, H J Maas, A Facius, S Yang, M Danhof, O Della Pasqua

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Pharmaceutical research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–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.

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

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Longitudinal FEVInternational journal of chronic obstructive pulmonary disease
    Trial
  3. Review
  4. Article
  5. Article
  6. Article
  7. 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

7 authors.

F T MusuambaGorlaeus Laboratories, Division of Pharmacology, Leiden Academic Centre for Drug Research, P.O. Box 9502, 2300 RA, Leiden, The Netherlands.
D Teutonico
H J Maas
A Facius
S Yang
M Danhof
O Della Pasqua

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeDrug development in chronic obstructive pulmonary disease (COPD) has been characterised by unacceptably high failure rates. In addition to the poor sensitivity in forced expiratory volume in one second (FEV1), numerous causes are known to contribute to this phenomenon, which can be clustered into drug-, disease- and design-related factors. Here we present a model-based approach to describe disease progression, treatment response and dropout in clinical trials with COPD patients.

methodsData from six phase II trials lasting up to 6 months were used. Disease progression (trough FEV1 measurements) was modelled by a time-varying function, whilst the treatment effect was described by an indirect response model. A time-to-event model was used for dropout

resultsAll relevant parameters were characterised with acceptable precision. Two parameters were necessary to model the dropout patterns, which was found to be partly linked to the treatment failure. Disease severity at baseline, previous use of corticosteroids, gender and height were significant covariates on disease baseline whereas disease severity and reversibility to salbutamol/salmeterol were significant covariates on Emax for salmeterol active arm.

conclusionIncorporation of the various interacting factors into a single model will offer the basis for patient enrichment and improved dose rationale in COPD.

Indexed as

Disease ProgressionPatient DropoutsAdultAgedAged, 80 and overFemaleForced Expiratory VolumeHumansMaleMiddle AgedPredictive Value of TestsPulmonary Disease, Chronic ObstructiveTreatment Outcome

Identifiers

PMID25231008
PMCPMC4300418

What OpenQuestion holds

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LicenceCC BY
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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.