Evidence map›Paper›PMID 20672296›Full record

Trial reportPediatric pulmonology2010

An 18-month study of the safety and efficacy of repeated courses of inhaled aztreonam lysine in cystic fibrosis.

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

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Pediatric pulmonology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01469364 (Aztreonam Lysine for Inhalation), which is not on this map. Cited by 65 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 7 pooled it
14.4field-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.

NCT01469364 phase4completednot on this mapstarted 2013, after this paper: background citation

Aztreonam Lysine for Inhalation (AZLI) in the Treatment of Early Bronchiolitis Obliterans Syndrome (BOS) After Lung Transplantation

TypeinterventionalSponsorDuke UniversityRan2013 to 2015Enrolled30ConditionsComplication of Transplanted LungArmsAztreonam Lysine for Inhalation (AZLI), Status Post Lung Transplant
3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 7 syntheses or guidelines pooled it, 189 citations in OpenAlex.

  1. Pooled it
  2. Inhaled antibiotics for pulmonary exacerbations in cystic fibrosis.The Cochrane database of systematic reviews · 2022
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Inhaled antibiotics for pulmonary exacerbations in cystic fibrosis.The Cochrane database of systematic reviews · 2018
    Pooled it
  6. Pooled it
  7. Pooled it
  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
  9. Trial
  10. Trial
  11. Review
  12. Article
  13. Article
  14. Review
  15. Role of inhaled antibiotics in the era of highly effective CFTR modulators.European respiratory review : an official journal of the European Respiratory Society · 2023
    Review
  16. Review
  17. Review
  18. Antibiotic resistance in chronic respiratory diseases: from susceptibility testing to the resistome.European respiratory review : an official journal of the European Respiratory Society · 2022
    Review
  19. Therapeutic Approach of ChronicAntibiotics (Basel, Switzerland) · 2021
    Article
  20. Review

5 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 6 institutions in 1 country.

Christopher M OermannBaylor College of Medicine, Houston, Texas, USA. coermann@bcm.tmc.edu
George Z Retsch-Bogart
Alexandra L Quittner
Ronald L Gibson
Karen S McCoy
A Bruce Montgomery
Peter J Cooper
Gilead Sciences (United States) · USBaylor College of Medicine · 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
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
X-LINKED HYPOPHOSPHATEMIAM01RR000065 · NCRR · VIRGINIA COMMONWEALTH UNIVERSITY · PI SANYAL, ARUN J · 1985 to 2010
$24.8M
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 M01 RR00065NCRR 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 RR10733
6 · The paper itself

Abstract

Chronic airway infection with Pseudomonas aeruginosa (PA) causes morbidity and mortality in patients with cystic fibrosis (CF). Additional anti-PA therapies are needed to improve health status and health-related quality of life. AIR-CF3 was an international 18-month, open-label study to evaluate the safety and efficacy of repeated courses of aztreonam for inhalation solution (AZLI, now marketed as Cayston®) in patients aged ≥ 6 years with CF and PA infection who previously participated in one of two Phase 3 studies: AIR-CF1 or AIR-CF2. Patients received up to nine courses (28 days on/28 days off) of 75 mg AZLI two (BID) or three times daily (TID) based on randomization in the previous trials. 274 patients, mean age 28.5 years (range: 8-74 years), participated. Mean treatment adherence was high (92.0% BID group, 88.0% TID group). Hospitalization rates were low and adverse events were consistent with CF. With each course of AZLI, FEV(1) and scores on the Cystic Fibrosis Questionnaire-Revised Respiratory Symptom scale improved and bacterial density in sputum was reduced. Benefits waned in the 28 days off therapy, but weight gain was sustained over the 18 months. There were no sustained decreases in PA susceptibility. A dose response was observed; AZLI TID-treated patients demonstrated greater improvements in lung function and respiratory symptoms over 18 months. Repeated intermittent 28-day courses of AZLI treatment were well tolerated. Clinical benefits in pulmonary function, health-related quality of life, and weight were observed with each course of therapy. AZLI is a safe and effective new therapy in patients with CF and PA airway infection.

Indexed as

Pseudomonas aeruginosaAdministration, InhalationAdolescentAdultAgedAnti-Bacterial AgentsAztreonamChildChronic DiseaseCystic FibrosisDose-Response Relationship, DrugFemaleHumansMaleMiddle AgedPatient ComplianceAnti-Bacterial AgentsAztreonam

Identifiers

PMID20672296
PMCPMC3867945
OpenAlexW2010268034

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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.