Evidence map›Paper›PMID 28839984›Full record

ArticleJournal of thoracic disease2017

Theobromine for the treatment of persistent cough: a randomised, multicentre, double-blind, placebo-controlled clinical trial.

Alyn H Morice, Lorcan McGarvey, Ian D Pavord, Bernard Higgins, Kian Fan Chung, Surinder S Birring

2 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Journal of thoracic disease, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.0field-weighted citation impact, top 22% 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.

NCT01515280 completednot on this map

Supplementary Study of Hull Airway Reflux Questionnaire Scores Before and After Treatment Study: A Multicentre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral Theobromine in the Management of Cough."

TypeobservationalSponsorHull University Teaching Hospitals NHS TrustRan2012 to 2013Enrolled57ConditionsCough
NCT01656668 phase3completednot on this map

A Multicentre, Double-Blind, Placebo-Controlled, Adaptive Pivotal Study of the Efficacy and Safety of Oral BC1036 in the Management of Cough

TypeinterventionalSponsorRespicopea LimitedRan2012 to 2013Enrolled288ConditionsCoughArmsBC1036
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 9 citations in OpenAlex.

  1. 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

6 authors at 5 institutions in 1 country.

Alyn H MoriceHull York Medical School, Castle Hill Hospital, Hull, UK.
Lorcan McGarveyCentre for Experimental Medicine, Queen's University Belfast, Belfast, Northern Ireland.
Ian D PavordNuffield Department of Medicine, University of Oxford, Oxford, UK.
Bernard HigginsSir William Leech Centre for Lung Research, Freeman Hospital, Newcastle, UK.
Kian Fan ChungNational Heart and Lung Institute, Imperial College London, and Biomedical Research Unit, Royal Brompton & Harefield NHS Trust, London, UK.
Surinder S BirringDivision of Asthma, Allergy and Lung Biology, King's College London, London, UK.
Castle Hill Hospital · GBFreeman Hospital · GBImperial College London · GBKing's College London · GBUniversity of Oxford · GB

Funding

Medical Research Council G1000758
6 · The paper itself

Abstract

backgroundTo investigate the effect of BC1036 on health-related quality of life (QOL) in subjects with persistent cough. The secondary objective was to investigate the effect of BC1036 on subjective cough severity.

methodsThis was a randomised, multicentre, double-blind, placebo-controlled, parallel-group study in 289 subjects with persistent cough. Subjects received BC1036 or placebo twice daily for 14 days. The primary endpoint comprised cough-related QOL assessed using the validated Leicester Cough Questionnaire (LCQ) at Day 14. Secondary endpoints comprised the LCQ scores at Day 7 and Day 28, cough severity VAS scores at each visit and pulmonary function tests.

resultsAt baseline, mean total LCQ score in the BC1036 group was lower (i.e., worse QOL) than placebo (P<0.001), indicating significant between-group heterogeneity. Mean baseline-adjusted change in LCQ score at Day 14 was greater for BC1036 [mean (SD) 2.4±3.5] compared to placebo [mean (SD) score 2.2±3.0], but did not reach statistical significance (P=0.60). Mean cough severity VAS score decreased to a greater extent in the BC1036 group compared to placebo, but again the results were not statistically significant (-12.2±23.28 in BC1036 group and -11.0±21.34 in placebo group at Day 14, P=0.688). There was no significant change in pulmonary function measurements. The adverse event (AE) profile was similar in both groups.

conclusionsThis study showed that BC1036 was well tolerated and, although the primary endpoint did not achieve statistical significance, the magnitude of improvement was greater with BC1036 compared to placebo with respect to improving QOL and reducing cough severity. CLINICAL

trial registrationClinicalTrials.gov: NCT01656668.

Indexed as

Cocoacontrolled clinical trialcoughquality of life (QOL)theobromine

Identifiers

PMID28839984
PMCPMC5542984
OpenAlexW2735193388

What OpenQuestion holds

Textmetadata
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.