Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa
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ClinicalTrials.gov Identifier: NCT00757237 |
Recruitment Status :
Completed
First Posted : September 23, 2008
Results First Posted : July 4, 2011
Last Update Posted : July 4, 2011
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Sponsor:
Gilead Sciences
Collaborators:
Chiltern International Inc.
ClinPhone, Inc.
Covance
Information provided by:
Gilead Sciences
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Cystic Fibrosis |
Interventions |
Drug: Aztreonam for Inhalation Solution (AZLI) Drug: Tobramycin Inhalation Solution (TIS) |
Enrollment | 274 |
Participant Flow
Recruitment Details | Seventy-three sites in the United States (US) and European Union (EU) enrolled a total of 274 participants in the study. |
Pre-assignment Details | Of the 274 participants enrolled in the study, 273 were randomized between 07 August 2008 and 12 November 2009. One subject experienced a serious adverse event (SAE) between Visits 1 and 2; this subject did not receive study drug. A total of 268 participants received study drug (136 AZLI; 132 TIS). |
Arm/Group Title | AZLI (75 mg TID) | TIS (300 mg BID) |
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AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer. | TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor. |
Period Title: Overall Study | ||
Started | 137 | 136 |
Treated | 136 | 132 |
Completed | 124 | 111 |
Not Completed | 13 | 25 |
Reason Not Completed | ||
Lost to Follow-up | 0 | 1 |
Protocol Violation | 0 | 2 |
Physician Decision | 2 | 3 |
Withdrawal by Subject | 8 | 12 |
Safety or Tolerability | 3 | 5 |
Other | 0 | 2 |
Baseline Characteristics
Arm/Group Title | AZLI (75 mg TID) | TIS (300 mg BID) | Total | |
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AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer. | TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor. | Total of all reporting groups | |
Overall Number of Baseline Participants | 136 | 132 | 268 | |
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[Not Specified]
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Age Categorical
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 136 participants | 132 participants | 268 participants |
>= 6 years to <= 12 years | 8 | 5 | 13 | |
> 12 years to < 18 years | 20 | 26 | 46 | |
>= 18 years | 108 | 101 | 209 | |
Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 136 participants | 132 participants | 268 participants | |
25.8 (9.1) | 25.1 (9.0) | 25.5 (9.0) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 136 participants | 132 participants | 268 participants | |
Female |
68 50.0%
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66 50.0%
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134 50.0%
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Male |
68 50.0%
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66 50.0%
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134 50.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 136 participants | 132 participants | 268 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
1 0.7%
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0 0.0%
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1 0.4%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
0 0.0%
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1 0.8%
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1 0.4%
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White |
130 95.6%
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131 99.2%
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261 97.4%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
5 3.7%
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0 0.0%
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5 1.9%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 136 participants | 132 participants | 268 participants |
United States | 44 | 50 | 94 | |
Europe | 92 | 82 | 174 | |
Body Mass Index (BMI)
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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Number Analyzed | 136 participants | 132 participants | 268 participants | |
20.22 (2.95) | 20.49 (2.82) | 20.35 (2.88) | ||
Inhaled Tobramycin Use in the Previous 12 Months
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 136 participants | 132 participants | 268 participants |
< 84 days | 21 | 19 | 40 | |
>= 84 days | 115 | 113 | 228 | |
Disease Severity
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 136 participants | 132 participants | 268 participants |
<= 50% predicted | 60 | 57 | 117 | |
> 50% predicted | 76 | 75 | 151 | |
[1]
Measure Description: Forced Expiratory Volume (FEV1) percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. This baseline measure indicates the number of participants with FEV1 greater than 50% and less than or equal to 50% of the predicted value based on age, gender, and height at screening.
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Forced Expiratory Volume (FEV1) Percent Predicted
[1] Mean (Standard Deviation) Unit of measure: Percent |
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Number Analyzed | 136 participants | 132 participants | 268 participants | |
52.30 (15.56) | 52.24 (14.57) | 52.27 (15.06) | ||
[1]
Measure Description: FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height.
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Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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Number Analyzed | 136 participants | 132 participants | 268 participants | |
62.87 (20.42) | 58.02 (20.76) | 60.44 (20.69) | ||
[1]
Measure Description: The CFQ-R is a validated, patient-reported outcome tool measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. Respiratory symptoms (e.g., coughing, congestion, wheezing) are assessed with the CFQ-R Respiratory Symptoms Scale (RSS). The range of scores (units) is 0 to 100 with higher scores indicating fewer symptoms.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other scholarly media only after the following conditions have been met:
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
The study has been completed at all study sites for at least 2 years.
Results Point of Contact
Name/Title: | Mark Bresnik, MD, Director, Clinical Research |
Organization: | Gilead Sciences, Inc. |
Phone: | (650) 522-5934 |
EMail: | mark.bresnik@gilead.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Mark Bresnik, MD/Medical Monitor, GSI |
ClinicalTrials.gov Identifier: | NCT00757237 |
Other Study ID Numbers: |
GS-US-205-0110 |
First Submitted: | September 22, 2008 |
First Posted: | September 23, 2008 |
Results First Submitted: | April 8, 2011 |
Results First Posted: | July 4, 2011 |
Last Update Posted: | July 4, 2011 |