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CompletedNCT00104520AIR-CF2Updated Mar 11, 2011Results posted

Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa

A Phase 3 interventional study of AZLI 75 mg two times a day (BID)/three times a day (TID) and Placebo two times a day (BID)/three times a day (TID) in Cystic Fibrosis, sponsored by Gilead Sciences. Completed at 56 sites in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2011-03-11.

Sponsored by Gilead Sciences · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
211
Allocation
Randomized
Ages
6 Years and older
Sex
All
01

Study summary

The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).

Read the detailed description

Patients with CF often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by a bacteria called PA. Treatment with antibiotics can stop or slow down the growth of the bacteria. The antibiotics may be given by mouth, intravenously (IV), or by inhalation as a mist. The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI), an investigational formulation of the antibiotic administered using the eFlow® Electronic Nebulizer by PARI GmbH, in CF patients with PA.

In this study, participants were screened for eligibility at Visit 1 (Day -42) and returned to the center for Visit 2 after a 14-day evaluation period. At Visit 2 (Day -28), participants began a 28-day course of open-label Tobramycin Inhalation Solution (TIS). At Visit 3 (Day 0), following completion of the 28-day course of TIS, participants began randomized, blinded treatment with either AZLI twice a day (BID) or three times a day (TID) or placebo BID or TID, and continued treatment for a total of 28 days, with a clinic visit at Day 14 (Visit 4) and at the end of treatment (Visit 5 [Day 28]). Participants returned for visits every 2 weeks for 8 weeks after the end of the blinded treatment (Visits 6 to 9 [Days 42 to 84]).

Two hundred and forty-seven participants were treated in the TIS phase of this study. Two hundred and eleven subjects completed the TIS phase and were treated in the placebo-controlled phase with study drug (AZLI or placebo).

02

Conditions studied

  • Cystic Fibrosis

Keywords

  • Cystic Fibrosis
  • Pseudomonas aeruginosa
  • Pulmonary Cystic Fibrosis
03

In context

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's enrollment of 211 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • CF as diagnosed by:

    1. Documented sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine iontophoresis test; or
    2. Two well-characterized genetic mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; or
    3. Abnormal nasal potential difference with accompanying symptoms characteristic of CF.
  • PA present in expectorated sputum or throat swab culture at Screening.
  • Participants must have received three or more courses of TIS within the previous 12 months.
  • Participants on chronic azithromycin must have had no change in regimen in the previous 3 months and must have had a need for TIS and/or additional antipseudomonal therapy since initiation of azithromycin.
  • Forced expiratory volume in 1 second (FEV1) between (and including) 25% and 75% predicted at Screening.
  • Ability to perform reproducible pulmonary function tests.
  • Arterial oxygen saturation (SaO2) greater than or equal to 90% on room air at Screening.

Exclusion criteria

Exclusion Criteria:

  • Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone a day or 20 mg prednisone every other day.
  • History of sputum or throat culture swab yielding Burkholderia cepacia in the past 2 years.
  • History of daily continuous oxygen supplementation or requirement for more than 2 liters/minute at night.
  • Administration of any investigational drug or device within 28 days of Screening (Visit 1) or within 6 half-lives of the investigational drug (whichever was longer).
  • Known local or systemic hypersensitivity to monobactam antibiotics.
  • Inability to tolerate inhalation of a short acting Beta-2 agonist.
  • Changes in antimicrobial, bronchodilator, anti-inflammatory, or corticosteroid medications within 7 days before Screening or between Screening and the next visit.
  • Changes in physiotherapy technique or schedule within 7 days before Screening or between Screening and the next visit.
  • History of lung transplantation.
  • A chest X-ray indicating abnormal findings at Screening or within the previous 90 days.
  • Abnormal renal or hepatic function or serum chemistry at Screening (aspartate aminotransferase [AST], alanine aminotransferase [ALT] greater than 5 times the upper limit of normal range; Creatinine greater than 2 times the upper limit of normal range).
  • Positive pregnancy test at Screening.
  • Female of childbearing potential who was lactating or in the opinion of the investigator was not practicing acceptable birth control.
  • Any serious or active medical or psychiatric illness, which in the opinion of the investigator would have interfered with participant treatment, assessment, or compliance with the protocol.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
211 participants (actual)

Study arms

  • Placebo comparator
    Placebo (pooled two times a day [BID]/three times a day [TID])

    Drug: Placebo two times a day (BID)/three times a day (TID)

  • Experimental
    AZLI (pooled two times a day [BID]/three times a day [TID])

    Drug: AZLI 75 mg two times a day (BID)/three times a day (TID)

Interventions

  • DrugAZLI 75 mg two times a day (BID)/three times a day (TID)
  • DrugPlacebo two times a day (BID)/three times a day (TID)
06

What researchers measure

Primary outcomes

  1. Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics

    The primary endpoint was time to need for a course of inhaled or IV antipseudomonal antibiotics with documented physician assessment of need for antibiotics. Antipseudomonal Antibiotic need was documented based on the presence of at least one of the following four symptoms predictive of pulmonary exacerbation: decreased exercise tolerance, increased cough, increased sputum / chest congestion, decreased appetite, or other.

    Time frame: Day 0 to Day 84 (end of study)

Secondary outcomes

  1. Change in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score

    The CFQ-R was administered at Day -28, baseline, Day 14, Day 28, and Day 84 (end of study). The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores \[units\]: 0-100; higher scores indicate fewer symptoms).

    Time frame: Day 0 to Day 28

  2. Percent Change in Forced Expiratory Volume in 1 Second (FEV1) (L)

    Spirometry was performed at each visit. FEV1 was recorded according to American Thoracic Society (ATS) guidelines. FEV1(L) is the measurement of the volume of air (expressed in liters) exhaled in 1 second. The percent change in this parameter from Day 0 to Day 28 was determined for each treatment group.

    Time frame: Day 0 to Day 28

  3. Number of Hospitalization Days

    Details of all hospitalizations, including the dates of admission and discharge, were recorded on the electronic case report form (eCRF).

    Time frame: Day 0 to Day 84

  4. Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum

    Sputum samples were collected at all participant visits of the study for analysis of microbiology endpoints. Sputum samples were processed for qualitative and quantitative culture of PA (each morphotype). Due to the skewness of the distribution of CFU data, the data were transformed using the base 10 logarithm, in an attempt to normalize the data and allow for parametric tests, before calculating changes. To account for zero values, 1 was added to each CFU measurement before being transformed. Any CFU data values where PA was not isolated from a valid culture were set to zero.

    Time frame: Day 0 to Day 28

Other outcomes

  1. Number of Participants With Other Pathogens

    Sputum samples were collected at all visits for quantitative and qualitative culture for Staphylococcus aureus, Burkholderia cepacia, Stenotrophomonas maltophilia, and Achromobacter xylosoxidans. Number of participants with other pathogens at baseline and at the end of treatment (28 days) are reported.

    Time frame: Day 0 and Day 28

  2. Minimum Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)

    The aztreonam susceptibility of PA isolates from sputum samples (collected at all visits) was assessed. MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism). MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism). MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis.

    Time frame: Day 0 to Day 28

07

Results

Posted Mar 11, 2011
Limitations and caveats
The study was designed such that participants were discontinued from study participation upon meeting the primary endpoint (time to need for inhaled or IV antipseudomonal antibiotics).

Participant flow

Participants were enrolled at 56 sites in the United States. Date of first enrollment was 24 February 2005, and date of last participant follow-up was 07 September 2006.

Participant flow — Overall Study
MilestonePlacebo (Pooled BID/TID)AZLI (Pooled BID/TID)
Started76135
Completed2664
Not completed5071
Withdrew: Unrelated adverse event3447
Withdrew: Study drug intolerance01
Withdrew: Related adverse event1315
Withdrew: Lost to follow-up10
Withdrew: Noncompliance02
Withdrew: Personal/administrative11
Withdrew: Other15

Outcome measures

PrimaryTime to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics

The primary endpoint was time to need for a course of inhaled or IV antipseudomonal antibiotics with documented physician assessment of need for antibiotics. Antipseudomonal Antibiotic need was documented based on the presence of at least one of the following four symptoms predictive of pulmonary exacerbation: decreased exercise tolerance, increased cough, increased sputum / chest congestion, decreased appetite, or other.

Time frame:
Day 0 to Day 84 (end of study)
Reported as:
Median · Days
Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics
DaysPlacebo (Pooled BID/TID)AZLI (Pooled BID/TID)
Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics71 (57 to 97)92 (89 to NA)
Statistical analysis
  • Placebo (Pooled BID/TID) vs AZLI (Pooled BID/TID) · Log Rank · p = 0.0070 (Analysis based on 2-sided test with 0.05 a priori threshold for statistical significance. No adjustments were made for multiple comparisons.)
SecondaryChange in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score

The CFQ-R was administered at Day -28, baseline, Day 14, Day 28, and Day 84 (end of study). The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores \[units\]: 0-100; higher scores indicate fewer symptoms).

Time frame:
Day 0 to Day 28
Reported as:
Least squares mean · Units on a scale
Change in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score
Units on a scalePlacebo (Pooled BID/TID)AZLI (Pooled BID/TID)
Change in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score-0.66 ± 1.7084.34 ± 1.27
Statistical analysis
  • Placebo (Pooled BID/TID) vs AZLI (Pooled BID/TID) · ANCOVA · p = 0.0196 (No adjustments were made for multiple comparisons.) · Mean difference (final values): 5.01 · 95% CI 0.81 to 9.21ANCOVA model included terms for treatment and baseline value.
SecondaryPercent Change in Forced Expiratory Volume in 1 Second (FEV1) (L)

Spirometry was performed at each visit. FEV1 was recorded according to American Thoracic Society (ATS) guidelines. FEV1(L) is the measurement of the volume of air (expressed in liters) exhaled in 1 second. The percent change in this parameter from Day 0 to Day 28 was determined for each treatment group.

Time frame:
Day 0 to Day 28
Reported as:
Least squares mean · Percent change in FEV1 (L)
Percent Change in Forced Expiratory Volume in 1 Second (FEV1) (L)
Percent change in FEV1 (L)Placebo (Pooled BID/TID)AZLI (Pooled BID/TID)
Percent Change in Forced Expiratory Volume in 1 Second (FEV1) (L)-2.363 ± 1.5343.917 ± 1.151
Statistical analysis
  • Placebo (Pooled BID/TID) vs AZLI (Pooled BID/TID) · ANCOVA · p = 0.0012 (No adjustments were made for multiple comparisons.) · Mean difference (final values): 6.280 · 95% CI 2.500 to 10.060ANCOVA model included terms for treatment and baseline value.
SecondaryNumber of Hospitalization Days

Details of all hospitalizations, including the dates of admission and discharge, were recorded on the electronic case report form (eCRF).

Time frame:
Day 0 to Day 84
Reported as:
Mean · Days
Number of Hospitalization Days
DaysPlacebo (Pooled BID/TID)AZLI (Pooled BID/TID)
Number of Hospitalization Days0.5 ± 2.40.9 ± 3.9
SecondaryChange From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum

Sputum samples were collected at all participant visits of the study for analysis of microbiology endpoints. Sputum samples were processed for qualitative and quantitative culture of PA (each morphotype). Due to the skewness of the distribution of CFU data, the data were transformed using the base 10 logarithm, in an attempt to normalize the data and allow for parametric tests, before calculating changes. To account for zero values, 1 was added to each CFU measurement before being transformed. Any CFU data values where PA was not isolated from a valid culture were set to zero.

Time frame:
Day 0 to Day 28
Reported as:
Least squares mean · Log10 PA CFUs/gram of sputum
Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum
Log10 PA CFUs/gram of sputumPlacebo (Pooled BID/TID)AZLI (Pooled BID/TID)
Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum0.225 ± 0.209-0.434 ± 0.167
Statistical analysis
  • Placebo (Pooled BID/TID) vs AZLI (Pooled BID/TID) · ANCOVA · p = 0.0059 · Mean difference (final values): -0.659 · 95% CI -1.125 to -0.193ANCOVA model included terms for treatment and baseline highest MIC of aztreonam for PA (\<=2, 4-8, 16-128 or \>=256 μg/mL) value.
Other pre-specifiedNumber of Participants With Other Pathogens

Sputum samples were collected at all visits for quantitative and qualitative culture for Staphylococcus aureus, Burkholderia cepacia, Stenotrophomonas maltophilia, and Achromobacter xylosoxidans. Number of participants with other pathogens at baseline and at the end of treatment (28 days) are reported.

Time frame:
Day 0 and Day 28
Reported as:
Number · Participants
Number of Participants With Other Pathogens
ParticipantsPlacebo (Pooled BID/TID)AZLI (Pooled BID/TID)
S. aureus - Day 02358
S. aureus - Day 282363
B. cepacia - Day 000
B. cepacia - Day 2800
S. maltophilia - Day 0918
S. maltophilia - Day 28819
A. xylosoxidans - Day 0610
A. xylosoxidans - Day 2867
Other pre-specifiedMinimum Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)

The aztreonam susceptibility of PA isolates from sputum samples (collected at all visits) was assessed. MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism). MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism). MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis.

Time frame:
Day 0 to Day 28
Reported as:
Number · μg/mL
Minimum Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)
μg/mLPlacebo (Pooled BID/TID)AZLI (Pooled BID/TID)
Baseline MIC5012
Day 28 MIC5014
Baseline MIC906432
Day 28 MIC906464

Adverse events

Collected over AEs that first occurred or worsened after the first dose of study drug through 30 days after the last dose (Day 0 to Day 56) are summarized.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo (Pooled BID/TID)—3/76 (3.9%)65/76 (85.5%)
AZLI (Pooled BID/TID)—13/135 (9.6%)121/135 (89.6%)
Most frequent serious events
Showing 10 of 20
Most frequent serious events
EventPlacebo (Pooled BID/TID)AZLI (Pooled BID/TID)
CoughRespiratory, thoracic and mediastinal disorders1/767/135
Productive coughRespiratory, thoracic and mediastinal disorders2/766/135
Pulmonary function test decreasedInvestigations0/764/135
DyspnoeaRespiratory, thoracic and mediastinal disorders2/762/135
Respiratory tract congestionRespiratory, thoracic and mediastinal disorders0/763/135
WheezingRespiratory, thoracic and mediastinal disorders0/762/135
Exercise tolerance decreasedGeneral disorders1/760/135
FatigueGeneral disorders1/760/135
Non-cardiac chest painRespiratory, thoracic and mediastinal disorders1/761/135
Abdominal pain lowerGastrointestinal disorders0/761/135
Most frequent other events
Showing 10 of 29
Most frequent other events
EventPlacebo (Pooled BID/TID)AZLI (Pooled BID/TID)
CoughRespiratory, thoracic and mediastinal disorders51/7681/135
Productive coughRespiratory, thoracic and mediastinal disorders27/7649/135
Nasal congestionRespiratory, thoracic and mediastinal disorders11/7628/135
Respiratory tract congestionRespiratory, thoracic and mediastinal disorders15/7620/135
HaemoptysisRespiratory, thoracic and mediastinal disorders14/7617/135
WheezingRespiratory, thoracic and mediastinal disorders9/7622/135
FatigueGeneral disorders12/7614/135
Decreased appetiteMetabolism and nutrition disorders11/7611/135
Pharyngolaryngeal painRespiratory, thoracic and mediastinal disorders9/7618/135
Crackles lungRespiratory, thoracic and mediastinal disorders10/7611/135

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Placebo (Pooled BID/TID)AZLI (Pooled BID/TID)Total
<=18 years123446
Between 18 and 65 years63101164
>=65 years101
Age Continuous
Age Continuous(years)Placebo (Pooled BID/TID)AZLI (Pooled BID/TID)Total
Mean27.9 ± 10.425.3 ± 10.226.2 ± 10.4
Sex: Female, Male
Sex: Female, Male(Participants)Placebo (Pooled BID/TID)AZLI (Pooled BID/TID)Total
Female315990
Male4576121
Region of Enrollment
Region of Enrollment(participants)Placebo (Pooled BID/TID)AZLI (Pooled BID/TID)Total
United States76135211
08

Study locations

56 sites
  • Phoenix Children's Hospital
    Phoenix, Arizona, United States
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas, United States
  • University of California, San Diego
    La Jolla, California, United States
  • Children's Hospital Los Angeles
    Los Angeles, California, United States
  • Kaiser Permanente Medical Care Program
    Oakland, California, United States
  • Children's Hospital, Orange Co.
    Orange, California, United States
  • Stanford University Hospital and Medical Center
    Palo Alto, California, United States
  • UC Davis Medical Center
    Sacramento, California, United States
  • Children's Hospital
    Denver, Colorado, United States
  • Connecticut Children's Medical Center
    Hartford, Connecticut, United States
  • University of Florida Health Sciences Center
    Gainesville, Florida, United States
  • Nemours Children's Clinic, Jacksonville
    Jacksonville, Florida, United States
  • University of Miami School of Medicine
    Miami, Florida, United States
  • Nemours Children's Clinic
    Orlando, Florida, United States
  • Pediatric Pulmonary Associates, Florida
    St. Petersburg, Florida, United States
  • Emory Healthcare
    Atlanta, Georgia, United States
  • Medical College of Georgia
    Augusta, Georgia, United States
  • Children's Memorial Hospital/Northwestern University
    Chicago, Illinois, United States
  • Chicago Children's Asthma Respiratory and Exercise Specialists
    Glenview, Illinois, United States
  • Loyola University Medical Center
    Maywood, Illinois, United States
  • North Suburban Pulmonary / Critical Care Consultants
    Niles, Illinois, United States
  • Indiana University
    Indianapolis, Indiana, United States
  • University of Kansas Medical Center
    Kansas City, Kansas, United States
  • Maine Medical Center
    Portland, Maine, United States
  • Children's Hospital, Boston
    Boston, Massachusetts, United States
  • Floating Hospital for Children
    Boston, Massachusetts, United States
  • Massachusetts General Hospital
    Boston, Massachusetts, United States
  • University of Michigan
    Ann Arbor, Michigan, United States
  • Children's Hospital of Michigan/Wayne State University
    Detroit, Michigan, United States
  • University of Minnesota
    Minneapolis, Minnesota, United States
  • Children's Lung Specialists, Ltd.
    Las Vegas, Nevada, United States
  • Morristown Memorial Hospital
    Morristown, New Jersey, United States
  • Albany Medical College
    Albany, New York, United States
  • Long Island College Hospital
    Brooklyn, New York, United States
  • Children's Hospital of Buffalo
    Buffalo, New York, United States
  • Long Island Jewish Medical Center
    New Hyde Park, New York, United States
  • Columbia University Medical Center
    New York, New York, United States
  • State University of New York Stony Brook
    Stony Brook, New York, United States
  • Children's Hospital of Westchester Medical Center/New York Medical College
    Valhalla, New York, United States
  • Akron Children's Hospital
    Akron, Ohio, United States
  • Columbus Children's Hospital, Ohio State University
    Columbus, Ohio, United States
  • Children's Medical Center
    Dayton, Ohio, United States
  • Dr. Santiago Reyes
    Oklahoma City, Oklahoma, United States
  • Oregon Health & Science University
    Portland, Oregon, United States
  • Penn State University Hershey Medical Center
    Hershey, Pennsylvania, United States
  • Drexel University College of Medicine
    Philadelphia, Pennsylvania, United States
  • St. Christopher's Hospital for Children
    Philadelphia, Pennsylvania, United States
  • Children's Hospital of Pittsburg
    Pittsburg, Pennsylvania, United States
  • Rhode Island Hospital
    Providence, Rhode Island, United States
  • Medical University of South Carolina
    Charleston, South Carolina, United States
  • Pediatric Pulmonary Associates, South Carolina
    Columbia, South Carolina, United States
  • Baylor College of Medicine
    Houston, Texas, United States
  • Alamo Clinical Research Associates
    San Antonio, Texas, United States
  • Pediatric Pulmonary Center
    Richmond, Virginia, United States
  • Children's Hospital and Regional Medical Center
    Seattle, Washington, United States
  • West Virginia University
    Morgantown, West Virginia, United States
09

References and documents

Publications

  • Quittner AL, Modi AC, Wainwright C, Otto K, Kirihara J, Montgomery AB. Determination of the minimal clinically important difference scores for the Cystic Fibrosis Questionnaire-Revised respiratory symptom scale in two populations of patients with cystic fibrosis and chronic Pseudomonas aeruginosa airway infection. Chest. 2009 Jun;135(6):1610-1618. doi: 10.1378/chest.08-1190. Epub 2009 May 15. PubMed 19447923 ↗
  • McCoy KS, Quittner AL, Oermann CM, Gibson RL, Retsch-Bogart GZ, Montgomery AB. Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. Am J Respir Crit Care Med. 2008 Nov 1;178(9):921-8. doi: 10.1164/rccm.200712-1804OC. Epub 2008 Jul 24. PubMed 18658109 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00104520
Lead sponsor
Gilead Sciences
First posted
Mar 2, 2005
Start date
Feb 2005
Primary completion
Sep 2006
Completion
Sep 2006
Results posted
Mar 11, 2011
Last update
Mar 11, 2011

Study contacts

Karen McCoy, MD
principal investigator · Nationwide Children's Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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