Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa (AIR-CF2)

This study has been completed.
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00104520
First received: March 1, 2005
Last updated: February 16, 2011
Last verified: September 2010
Results First Received: September 10, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cystic Fibrosis
Interventions: Drug: AZLI 75 mg two times a day (BID)/three times a day (TID)
Drug: Placebo two times a day (BID)/three times a day (TID)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were randomized in 1:1:2:2 ratio to placebo twice a day (BID) or three times a day (TID) and AZLI BID or TID, respectively. A total of 211 subjects were included in the ITT analyses: 38 placebo BID, 38 placebo TID, 69 AZLI BID, and 66 AZLI TID. All analyses were conducted on pooled placebo (n = 76) versus pooled AZLI (n = 135) groups.

Reporting Groups
  Description
Placebo (Pooled BID/TID) Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
AZLI (Pooled BID/TID) AZLI (75 mg/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 BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.

Participant Flow:   Overall Study
    Placebo (Pooled BID/TID)     AZLI (Pooled BID/TID)  
STARTED     76     135  
COMPLETED     26     64  
NOT COMPLETED     50     71  
Unrelated adverse event                 34                 47  
Study drug intolerance                 0                 1  
Related adverse event                 13                 15  
Lost to Follow-up                 1                 0  
Noncompliance                 0                 2  
Personal/administrative                 1                 1  
Unknown                 1                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo (Pooled BID/TID) Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
AZLI (Pooled BID/TID) AZLI (75 mg/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 BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
Total Total of all reporting groups

Baseline Measures
    Placebo (Pooled BID/TID)     AZLI (Pooled BID/TID)     Total  
Number of Participants  
[units: participants]
  76     135     211  
Age  
[units: participants]
     
<=18 years     12     34     46  
Between 18 and 65 years     63     101     164  
>=65 years     1     0     1  
Age  
[units: years]
Mean ± Standard Deviation
  27.9  ± 10.4     25.3  ± 10.2     26.2  ± 10.4  
Gender  
[units: participants]
     
Female     31     59     90  
Male     45     76     121  
Region of Enrollment  
[units: participants]
     
United States     76     135     211  



  Outcome Measures
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1.  Primary:   Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics   [ Time Frame: Day 0 to Day 84 (end of study) ]

2.  Secondary:   Change in Cystic Fibrosis Questionnaire – Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score   [ Time Frame: Day 0 to Day 28 ]

3.  Secondary:   Percent Change in Forced Expiratory Volume in 1 Second (FEV1) (L)   [ Time Frame: Day 0 to Day 28 ]

4.  Secondary:   Number of Hospitalization Days   [ Time Frame: Day 0 to Day 84 ]

5.  Secondary:   Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum   [ Time Frame: Day 0 to Day 28 ]

6.  Other Pre-specified:   Number of Participants With Other Pathogens   [ Time Frame: Day 0 and Day 28 ]

7.  Other Pre-specified:   Minimum Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)   [ Time Frame: Day 0 to Day 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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).


  More Information
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Certain Agreements:  
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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Mark Bresnik, MD, Director, Clinical Research
Organization: Gilead Sciences, Inc.
phone: (650) 522-5934
e-mail: mark.bresnik@gilead.com


No publications provided by Gilead Sciences

Publications automatically indexed to this study:

Responsible Party: Mark Bresnik, MD, Director, Clinical Research, Gilead Sciences, Inc.
ClinicalTrials.gov Identifier: NCT00104520     History of Changes
Other Study ID Numbers: CP-AI-005
Study First Received: March 1, 2005
Results First Received: September 10, 2010
Last Updated: February 16, 2011
Health Authority: United States: Food and Drug Administration