Evidence map›Paper›PMID 19420195›Full record

Trial reportChest2009

Efficacy and safety of inhaled aztreonam lysine for airway pseudomonas in cystic fibrosis.

George Z Retsch-Bogart, Alexandra L Quittner, Ronald L Gibson, Christopher M Oermann, Karen S McCoy, A Bruce Montgomery, Peter J Cooper

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

Trial report in Chest, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00112359 (A Phase 3, Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary Pseudomonas Aeruginosa), which is not on this map. Cited by 108 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
108citing papers in PubMed, 6 pooled it
17.0field-weighted citation impact, top 1% 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.

NCT00112359 phase3completednot on this map

A Phase 3, Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary Pseudomonas Aeruginosa (AIR-CF1)

TypeinterventionalSponsorGilead SciencesRan2005 to 2007Enrolled166ConditionsCystic FibrosisArmsAZLI 75 mg three times a day (TID), Placebo three times a day (TID)
3 · Its place in the literature

Who cites it

108 citing papers in PubMed, 6 syntheses or guidelines pooled it, 276 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Inhaled antibiotics for pulmonary exacerbations in cystic fibrosis.The Cochrane database of systematic reviews · 2022
    Pooled it
  5. Inhaled antibiotics for pulmonary exacerbations in cystic fibrosis.The Cochrane database of systematic reviews · 2018
    Pooled it
  6. Pooled it
  7. Trial
  8. Long-term amikacin liposome inhalation suspension in cystic fibrosis patients with chronic P. aeruginosa infection.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2021
    Trial
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48 more citing papers are in PubMed but not listed here.

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 7 institutions in 2 countries.

George Z Retsch-BogartUniversity of North Carolina at Chapel Hill, Chapel Hill, NC. Electronic address: gzrb@med.unc.edu.
Alexandra L QuittnerUniversity of Miami, Coral Gables, FL.
Ronald L GibsonChildren's Hospital and Regional Medical Center, Seattle, WA.
Christopher M OermannBaylor College of Medicine, Houston, TX.
Karen S McCoyOhio State University, Columbus, OH.
A Bruce MontgomeryGilead Sciences, Inc, Seattle, WA.
Peter J CooperThe Children's Hospital at Westmead, Sydney, NSW, Australia.
Baylor College of Medicine · USChildren's Hospital at Westmead · AUGilead Sciences (United States) · USSeattle Children's Hospital · USThe Ohio State University · USUniversity of Miami · USUniversity of North Carolina at Chapel Hill · US

Funding

ZOPOLRESTAT IN NORMOTENSIVE, TYPE 1 DIA WITH INCIPIENT NEPHROPATHYM01RR000043 · NCRR · UNIVERSITY OF SOUTHERN CALIFORNIA · PI ZAIA, JOHN A · 1985 to 2010
$76.4M
ZOVIRAX CREAM TO TREAT HERPES LABIALIS IN ADOLESCENTSM01RR000827 · NCRR · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI CHANG, R JEFFREY · 1985 to 2010
$74.3M
ZINC GLUCONATE GLYCINE LOZENGES &VITAMIN C EFFECTS ON COMMON COLDM01RR000042 · NCRR · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI RUBENFIRE, MELVYN · 1985 to 2007
$40.8M
ZD6416 Analgesic--Painful Distal Symmetrical PolyneuropaM01RR001066 · NCRR · MASSACHUSETTS GENERAL HOSPITAL · PI BROWN, EMERY N · 1985 to 2008
$37.4M
ZIPRASIDONE IN NORMAL HEPATIC FUNCTION SUBJECTS &IN HEPATIC DYSFUCTIN SUBJECTSM01RR000037 · NCRR · UNIVERSITY OF WASHINGTON · PI MCDONALD, RUTH C · 1985 to 2007
$33.8M
YOUTH DRUG ABUSE, ADHD, AND RELATED DISRUPTIVE DISORDERSM01RR000400 · NCRR · UNIVERSITY OF MINNESOTA TWIN CITIES · PI BACHANOVA, VERONIKA S · 1985 to 2009
$33.7M
XOLAIR IN SUBJECTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS WITH FOOD ALLERGYM01RR000070 · NCRR · STANFORD UNIVERSITY · PI RASGON, NATALIE L · 1985 to 2008
$32.4M
ZOLENDRONIC ACID IN CHILDREN W/ SEVERE OSTEOGENESIS IMPERFECTAM01RR000188 · NCRR · BAYLOR COLLEGE OF MEDICINE · PI SHEARER, WILLIAM THOMAS · 1985 to 2011
$30.6M
WHITE MATTER AND COGNITION IN PARKINSON'S DISEASEM01RR000082 · NCRR · UNIVERSITY OF FLORIDA · PI FOOTE, KELLY D · 1985 to 2009
$29.7M
University of Iowa Clinical and Translational Science Program (TL1)UL1RR025755 · NCRR · OHIO STATE UNIVERSITY · PI JACKSON, REBECCA D · 2008 to 2011
$26.3M
Atlanta Clinical and Translational Science Institute (ACTSI) RenewalUL1TR000454 · NCATS · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2012 to 2016
$25.8M
ZOSUQUIDAR TRIHYDROCHLORIDE DURING CONVENTIONAL INDUCTION AND POST-REMISSIONM01RR000750 · NCRR · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI RODRIGUEZ, HENRY · 1985 to 2008
$25.5M
NCATS NIH HHS UL1 TR000454NCRR NIH HHS M01 RR000034NCRR NIH HHS M01 RR000037NCRR NIH HHS M01 RR000039NCRR NIH HHS M01 RR000042NCRR NIH HHS M01 RR000043NCRR NIH HHS M01 RR000065NCRR NIH HHS M01 RR000069NCRR NIH HHS M01 RR000070NCRR NIH HHS M01 RR000082NCRR NIH HHS M01 RR000188NCRR NIH HHS M01 RR00034NCRR NIH HHS M01 RR00037NCRR NIH HHS M01 RR00039NCRR NIH HHS M01 RR000400NCRR NIH HHS M01 RR00042NCRR NIH HHS M01 RR00043NCRR NIH HHS M01 RR000489NCRR NIH HHS M01RR00065NCRR NIH HHS M01 RR00069NCRR NIH HHS M01 RR00070NCRR NIH HHS M01 RR000750NCRR NIH HHS M01 RR00082NCRR NIH HHS M01 RR000827NCRR NIH HHS M01 RR001066NCRR NIH HHS M01 RR001070NCRR NIH HHS M01 RR00188NCRR NIH HHS M01 RR002172NCRR NIH HHS M01 RR00400NCRR NIH HHS M01 RR00750NCRR NIH HHS M01 RR00827NCRR NIH HHS M01 RR01066NCRR NIH HHS M01 RR010710NCRR NIH HHS M01 RR02172NCRR NIH HHS M01 RR023940NCRR NIH HHS M01 RR10710NCRR NIH HHS M01 RR10733NCRR NIH HHS UL1 RR025755
6 · The paper itself

Abstract

backgroundWe assessed the short-term efficacy and safety of aztreonam lysine for inhalation (AZLI [an aerosolized monobactam antibiotic]) in patients with cystic fibrosis (CF) and Pseudomonas aeruginosa (PA) airway infection.

methodsIn this randomized, double-blind, placebo-controlled, international study (AIR-CF1 trial; June 2005 to April 2007), patients (n = 164; >or= 6 years of age) with FEV(1) >or= 25% and <or= 75% predicted values, and no recent use of antipseudomonal antibiotics or azithromycin were treated with 75 mg of AZLI (three times daily for 28 days) or placebo (1:1 randomization), then were monitored for 14 days after study drug completion. The primary efficacy end point was change in patient-reported respiratory symptoms (CF-Questionnaire-Revised [CFQ-R] Respiratory Scale). Secondary end points included changes in pulmonary function (FEV(1)), sputum PA density, and nonrespiratory CFQ-R scales. Adverse events and minimum inhibitory concentrations of aztreonam for PA were monitored.

resultsAfter 28 days of treatment, AZLI improved the mean CFQ-R respiratory score (9.7 points; p < 0.001), FEV(1) (10.3% predicted; p < 0.001), and sputum PA density (- 1.453 log(10) cfu/g; p < 0.001), compared with placebo. Significant improvements in Eating, Emotional Functioning, Health Perceptions, Physical Functioning, Role Limitation/School Performance, and Vitality CFQ-R scales were observed. Adverse events were consistent with symptoms of CF lung disease and were comparable for AZLI and placebo except the incidence of "productive cough" was reduced by half in AZLI-treated patients. PA aztreonam susceptibility at baseline and end of therapy were similar.

conclusionsIn patients with CF, PA airway infection, moderate-to-severe lung disease, and no recent use of antipseudomonal antibiotics or azithromycin, 28-day treatment with AZLI significantly improved respiratory symptoms and pulmonary function, and was well tolerated.

trial registrationClinicaltrials.gov Identifier: NCT00112359.

Indexed as

Administration, InhalationAdolescentAdultAgedAnti-Bacterial AgentsAztreonamChildCystic FibrosisDouble-Blind MethodFemaleForced Expiratory VolumeHumansMaleMiddle AgedPseudomonas InfectionsSputumAnti-Bacterial AgentsAztreonam

Identifiers

PMID19420195
PMCPMC2818415
OpenAlexW2110828250

What OpenQuestion holds

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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.