Evidence map›Paper›PMID 22383665›Full record

Trial reportChest2012

ADRB2 polymorphisms and budesonide/formoterol responses in COPD.

Eugene R Bleecker, Deborah A Meyers, William C Bailey, Anne-Marie Sims, Sarah R Bujac, Mitch Goldman, Ubaldo J Martin

2 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Chest, 2012. 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 11 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 6 pooled it
3.2field-weighted citation impact, top 8% 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.

NCT00206154 phase3completednot on this map

A 6-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg Bid Compared to Formoterol TBH, Budesonide pMDI (& the Combination) & Placebo in COPD Patients

TypeinterventionalSponsorAstraZenecaRan2005 to 2006Enrolled1,500ConditionsChronic Obstructive Pulmonary DiseaseArmsBudesonide/formoterol pMDI, Budesonide pMDI, Formoterol Turbuhaler
NCT00206167 phase3completednot on this map

A 12-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy and Safety Study of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid Compared to Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD

TypeinterventionalSponsorAstraZenecaRan2005 to 2007Enrolled1,600ConditionsChronic Obstructive Pulmonary DiseaseArmsBudesonide/formoterol pMDI, Formoterol Turbuhaler
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 6 syntheses or guidelines pooled it, 35 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Long-acting beta2-agonists for chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2013
    Pooled it
  6. Pooled it
  7. Predicting treatable traits for long-acting bronchodilators in patients with stable COPD.International journal of chronic obstructive pulmonary disease · 2017
    Trial
  8. Review
  9. Article
  10. βJournal of clinical medicine · 2019
    Article
  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

7 authors at 4 institutions in 2 countries.

Eugene R BleeckerCenter for Genomics and Personalized Medicine, Wake Forest School of Medicine, Winston-Salem, NC. Electronic address: ebleeck@wakehealth.edu.
Deborah A MeyersCenter for Genomics and Personalized Medicine, Wake Forest School of Medicine, Winston-Salem, NC.
William C BaileyUniversity of Alabama Lung Health Center, University of Alabama at Birmingham, Birmingham, AL.
Anne-Marie SimsAstraZeneca, Alderley Park, England.
Sarah R BujacAstraZeneca, Alderley Park, England.
Mitch GoldmanAstraZeneca LP, Wilmington, DE.
Ubaldo J MartinAstraZeneca LP, Wilmington, DE.
AstraZeneca (United Kingdom) · GBAstraZeneca (United States) · USWake Forest University · USUniversity of Alabama at Birmingham · US

Funding

NHLBI NIH HHS HL 056899
6 · The paper itself

Abstract

backgroundEffects of β(2)-adrenergic receptor gene (ADRB2) polymorphism on therapeutic responses to long-acting β(2)-adrenergic agonists have not been evaluated in long-term COPD trials. We aimed to investigate the effects of the ADRB2 Gly16Arg polymorphism on response to formoterol alone or in combination with the inhaled corticosteroid budesonide in patients with COPD.

methodsPatients ≥ 40 years of age with moderate to very severe COPD from the 12-month trial I (NCT00206167) or the 6-month trial II (NCT00206154) were randomly assigned to bid budesonide/formoterol pressurized metered-dose inhaler (pMDI) 320/9 μg or 160/9 μg, budesonide pMDI 320 μg + formoterol dry powder inhaler 9 μg (trial II), budesonide pMDI 320 μg (trial II), formoterol dry powder inhaler 9 μg, or placebo. The effect of Gly16Arg on predose FEV(1) and 1-h postdose FEV(1), exacerbations, diary variables, and adverse events were analyzed.

resultsNo significant interaction between genotype and treatment response was observed for predose (P ≥ .197) or postdose FEV(1) (P ≥ .125) in either pharmacogenetic study (n = 2,866). The number of COPD exacerbations per patient-treatment year was low and similar across genotypes for the active treatment groups (both studies). Percentages of patients with adverse events were similar across Gly16Arg genotype groups for each treatment.

conclusionTherapeutic response and tolerability to long-term treatment with formoterol alone or in combination with budesonide was not modified by ADRB2 Gly16Arg genotype in two large independent pharmacogenetic studies in patients with moderate to very severe COPD.

Indexed as

Administration, InhalationAdrenal Cortex HormonesAgedBronchodilator AgentsBudesonideBudesonide, Formoterol Fumarate Drug CombinationDouble-Blind MethodDrug Administration ScheduleDrug CombinationsDrug ToleranceEthanolaminesFemaleFormoterol FumarateHumansMaleMiddle AgedADRB2 protein, humanAdrenal Cortex HormonesBronchodilator AgentsBudesonideBudesonide, Formoterol Fumarate Drug CombinationDrug CombinationsEthanolaminesFormoterol FumarateReceptors, Adrenergic, beta-2

Identifiers

PMID22383665
PMCPMC3425335
OpenAlexW1979811409

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.