Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA) (AIR-CF3)
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ClinicalTrials.gov Identifier: NCT00128492 |
Recruitment Status :
Completed
First Posted : August 10, 2005
Results First Posted : March 11, 2011
Last Update Posted : May 19, 2011
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Cystic Fibrosis |
Intervention |
Drug: AZLI 75 mg two times a day (BID)/ three times a day (TID) |
Enrollment | 274 |
Recruitment Details | Open-label, Phase 3 follow-on study for participants from Studies CP-AI-005 (NCT00104520) and CP-AI-007 (NCT00112359). Participants were enrolled at 71 sites in the United States, Canada, Australia, and New Zealand. The date of first enrollment was 17 August 2005, and the date of database lock was 23 January 2009. |
Pre-assignment Details | Participants enrolled in this study were required to have previously participated in CP-AI-005 or CP-AI-007. Participants from CP-AI-005 received open-label AZLI (75 mg) in the same regimen (twice daily [BID] or three times daily [TID]) to which they were previously randomized. Participants from CP-AI-007 received open-label AZLI (75 mg) TID. |
Arm/Group Title | 75 mg AZLI Two Times a Day (BID) | 75 mg AZLI Three Times a Day (TID) |
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Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily |
Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
Period Title: Overall Study | ||
Started | 85 | 189 |
Completed | 65 | 130 |
Not Completed | 20 | 59 |
Reason Not Completed | ||
AE unrelated to study | 2 | 9 |
Study drug intolerance (AE) | 2 | 8 |
AE related to study | 1 | 4 |
Death | 1 | 0 |
Lost to Follow-up | 1 | 5 |
Noncompliance | 0 | 5 |
Personal or administrative | 10 | 22 |
Withdrawal by Subject | 3 | 5 |
Pregnancy | 0 | 1 |
Arm/Group Title | 75 mg AZLI Two Times a Day (BID) | 75 mg AZLI Three Times a Day (TID) | Total | |
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Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily |
Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
Total of all reporting groups | |
Overall Number of Baseline Participants | 85 | 189 | 274 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 85 participants | 189 participants | 274 participants | |
<=18 years |
19 22.4%
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36 19.0%
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55 20.1%
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Between 18 and 65 years |
65 76.5%
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151 79.9%
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216 78.8%
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>=65 years |
1 1.2%
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2 1.1%
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3 1.1%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 85 participants | 189 participants | 274 participants | |
27.3 (11.4) | 29.0 (13.0) | 28.5 (12.5) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 85 participants | 189 participants | 274 participants | |
Female |
34 40.0%
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89 47.1%
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123 44.9%
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Male |
51 60.0%
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100 52.9%
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151 55.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 85 participants | 189 participants | 274 participants |
United States | 85 | 157 | 242 | |
Canada | 0 | 8 | 8 | |
Australia | 0 | 22 | 22 | |
New Zealand | 0 | 2 | 2 | |
Aztreonam Minimum Inhibitory Concentration (MIC) for Pseudomonas aeruginosa (PA)
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 85 participants | 189 participants | 274 participants |
Aztreonam MIC > 8 µg/mL | 30 | 72 | 102 | |
Aztreonam MIC < or = 8 µg/mL | 46 | 99 | 145 | |
Unknown | 9 | 18 | 27 | |
[1]
Measure Description: Number of partipipants with an MIC of aztreonam ≤ 8 µg/mL or >8 µg/mL for PA are summarized.
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Disease severity as defined by FEV1 percent predicted category
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 85 participants | 189 participants | 274 participants |
FEV1 > 50% predicted | 49 | 114 | 163 | |
FEV1 ≤ 50% predicted | 36 | 74 | 110 | |
Unknown | 0 | 1 | 1 | |
[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. This baseline measure indicates the number of subjects 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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Body Mass Index (BMI)
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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Number Analyzed | 85 participants | 189 participants | 274 participants | |
21.30 (3.25) | 21.44 (3.96) | 21.40 (3.75) | ||
Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Score (CFQ-R RSS)
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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Number Analyzed | 85 participants | 189 participants | 274 participants | |
65.410 (16.896) | 60.332 (18.497) | 61.895 (18.141) | ||
[1]
Measure Description: CFQ-R RSS scale range 0-100, with higher scores indicating fewer CF symptoms.
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Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted
[1] Mean (Standard Deviation) Unit of measure: Percent |
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Number Analyzed | 85 participants | 189 participants | 274 participants | |
56.711 (17.505) | 55.071 (15.428) | 55.582 (16.089) | ||
[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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Log10 Pseudomonas aeruginosa (PA) Colony-Forming Units (CFUs) in Sputum
Mean (Standard Deviation) Unit of measure: Log10 CFUs/g |
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Number Analyzed | 85 participants | 189 participants | 274 participants | |
5.71 (2.249) | 6.16 (1.894) | 6.02 (2.014) | ||
Weight
Mean (Standard Deviation) Unit of measure: Kg |
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Number Analyzed | 85 participants | 189 participants | 274 participants | |
59.52 (13.28) | 59.28 (15.81) | 59.36 (15.05) |
Name/Title: | Mark Bresnik, Director of Clinical Research |
Organization: | Gilead Sciences, Inc. |
Phone: | 650-522-5934 |
EMail: | Mark.Bresnik@gilead.com |
Responsible Party: | Mark Bresnik, MD, Director, Clinical Research, Gilead Sciences, Inc. |
ClinicalTrials.gov Identifier: | NCT00128492 |
Other Study ID Numbers: |
CP-AI-006 |
First Submitted: | August 8, 2005 |
First Posted: | August 10, 2005 |
Results First Submitted: | June 3, 2010 |
Results First Posted: | March 11, 2011 |
Last Update Posted: | May 19, 2011 |