Trial · NCT00112359
International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa
NCT00112359, Phase 3, Completed, Gilead Sciences; results first posted 2011-04-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa. Trials, record NCT00112359. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00112359
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa
- NCT number
- NCT00112359
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 166 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Cystic Fibrosis
- Interventions
- AZLI 75 mg three times a day (TID), Placebo three times a day (TID)
- First posted
- 2005-06-02
- Last updated
- 2011-04-21
- Results first posted
- 2011-04-21
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in CFQ-R Respiratory Symptoms Scale (RSS) Score | Day 0 to Day 28 | The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R respiratory symptoms scale (RSS; range of scores: 0-100; higher scores indicate fewer symptoms). |
| Secondary | Change in CFQ-R RSS Score | Day 0 to Day 14 | The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms). |
| Secondary | Change in CFQ-R RSS Score | Day 0 to Day 42 | The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms). |
| Secondary | Percent Change in FEV1 (L) | Day 0 to Day 28 | Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. The percent change from baseline in forced expiratory volume (liters) in one second (FEV1) was determined at Day 28. |
| Secondary | Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum | Day 0 to Day 28 | 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. |
| Secondary | Number of Participants Receiving Intravenous (IV) or Inhaled Antipseudomonal Antibiotics Other Than Trial Drug | Day 0 to Day 42 | Use of IV and inhaled antipseudomonal antibiotics was compiled from data recorded on the Concomitant Medications eCRF. |
| Secondary | Number of Participants Hospitalized at Least Once Between Day 0 and Day 42 | Day 0 to Day 42 | Details of all hospitalizations, including the dates of admission and discharge, were recorded on the SAE eCRF. |
| Other | Number of Participants With Other Pathogens Present | Day 0 to Day 28 | Sputum samples were collected at all visits for quantitative and qualitative culture for Staphylococcus aureus, Burkholderia cepacia, Stenotrophomonas maltophilia, Achromobacter xylosoxidans. |
| Other | Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL) | Day 0 | PA isolates from sputum samples (collected at all visits) were assessed for their susceptibility to aztreonam. 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. |
| Other | Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL) | Day 28 | PA isolates from sputum samples (collected at all visits) were assessed for their susceptibility to aztreonam. 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Change in CFQ-R RSS Score | Day 0 to Day 14 | ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in CFQ-R RSS Score | Day 0 to Day 42 | ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used. | units on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Other Pathogens Present | Day 0 to Day 28 | Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL) | Day 0 | Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis. | μg/mL | NUMBER |
| SECONDARY | Percent Change in FEV1 (L) | Day 0 to Day 28 | ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used. | Percent change in FEV1 (L) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum | Day 0 to Day 28 | Analysis based on ITT population (all participants randomized to treatment who received at least part of 1 dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis. | Log10 PA CFUs/gram of sputum | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Receiving Intravenous (IV) or Inhaled Antipseudomonal Antibiotics Other Than Trial Drug | Day 0 to Day 42 | Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. | participants | NUMBER |
| PRIMARY | Change in CFQ-R Respiratory Symptoms Scale (RSS) Score | Day 0 to Day 28 | ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Hospitalized at Least Once Between Day 0 and Day 42 | Day 0 to Day 42 | Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL) | Day 28 | Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis. | μg/mL | NUMBER |
Source ClinicalTrials.gov
Results by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in CFQ-R RSS Score | Placebo TID | 0.976 | Standard Error 1.624 | units on a scale | |
| Change in CFQ-R RSS Score | 75 mg AZLI TID | 7.007 | Standard Error 1.647 | units on a scale | |
| Change in CFQ-R RSS Score | Placebo TID | -5.711 | Standard Error 1.849 | units on a scale | |
| Change in CFQ-R RSS Score | 75 mg AZLI TID | 0.618 | Standard Error 1.875 | units on a scale | |
| Number of Participants With Other Pathogens Present | Placebo TID | Staphylococcus aureus - Day 0 | 30 | participants | |
| Number of Participants With Other Pathogens Present | 75 mg AZLI TID | Staphylococcus aureus - Day 0 | 37 | participants | |
| Number of Participants With Other Pathogens Present | Placebo TID | Staphylococcus aureus - Day 28 | 31 | participants | |
| Number of Participants With Other Pathogens Present | 75 mg AZLI TID | Staphylococcus aureus - Day 28 | 35 | participants | |
| Number of Participants With Other Pathogens Present | Placebo TID | Burkholderia cepacia - Day 0 | 0 | participants | |
| Number of Participants With Other Pathogens Present | 75 mg AZLI TID | Burkholderia cepacia - Day 0 | 1 | participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo TID | 84 | |
| Overall Study | STARTED | 75 mg AZLI TID | 80 | |
| Overall Study | COMPLETED | Placebo TID | 57 | |
| Overall Study | COMPLETED | 75 mg AZLI TID | 67 | |
| Overall Study | NOT COMPLETED | Placebo TID | 27 | |
| Overall Study | NOT COMPLETED | 75 mg AZLI TID | 13 |
Source ClinicalTrials.gov
Adverse events116
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Placebo TID | 6 | 84 | |
| other | Abdominal pain | Gastrointestinal disorders | 75 mg AZLI TID | 6 | 80 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo TID | 5 | 84 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | 75 mg AZLI TID | 0 | 80 | |
| other | Chest discomfort | Respiratory, thoracic and mediastinal disorders | Placebo TID | 4 | 84 | |
| other | Chest discomfort | Respiratory, thoracic and mediastinal disorders | 75 mg AZLI TID | 5 | 80 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo TID | 27 | 84 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | 75 mg AZLI TID | 38 | 80 | |
| other | Crackles lung | Respiratory, thoracic and mediastinal disorders | Placebo TID | 6 | 84 | |
| other | Crackles lung | Respiratory, thoracic and mediastinal disorders | 75 mg AZLI TID | 9 | 80 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo TID | ||
| Total, all-cause mortality | 75 mg AZLI TID | ||
| Total, other adverse events | Placebo TID | 67 | 84 |
| Total, other adverse events | 75 mg AZLI TID | 63 | 80 |
| Total, serious adverse events | Placebo TID | 12 | 84 |
| Total, serious adverse events | 75 mg AZLI TID | 5 | 80 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19420195 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 75 mg AZLI TID vs Placebo TID: Number of Participants Hospitalized at Least Once Between Day 0 and Day 42 | Trial comparisons |
| 75 mg AZLI TID vs Placebo TID: Number of Participants Receiving Intravenous (IV) or Inhaled Antipseudomonal Antibiotics Other Than Trial Drug | Trial comparisons |
| 75 mg AZLI TID vs Placebo TID: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00112359
GET https://conductscience.org/api/trials/v1/NCT00112359/results?page=2