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Aztreonam Lysine for Pseudomonas Infection Eradication Study (ALPINE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01375049
First Posted: June 17, 2011
Last Update Posted: July 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
Results First Submitted: May 29, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Cystic Fibrosis
Intervention: Drug: Aztreonam for Inhalation Solution (AZLI)

  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 a total of 46 study sites in the United States and Europe. The first participant was screened on 04 October 2011. The last participant observation occurred on 29 May 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
109 participants were screened; 105 participants were enrolled and treated, and comprise the Safety Analysis Set and the Full Analysis Set.

Reporting Groups
  Description
AZLI Participants received one 28-day course of Aztreonam for Inhalation Solution (AZLI), then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.

Participant Flow:   Overall Study
    AZLI
STARTED   105 
COMPLETED   55 
NOT COMPLETED   50 
Adverse Event                2 
Lost to Follow-up                1 
Withdrawal by Subject                2 
Protocol-Specified Withdrawal Criteria                45 



  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.
Safety Analysis Set: participants who received at least 1 dose of study drug

Reporting Groups
  Description
AZLI Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.

Baseline Measures
   AZLI 
Overall Participants Analyzed 
[Units: Participants]
 105 
Age 
[Units: Years]
Mean (Standard Deviation)
 6.26  (4.743) 
Age, Customized 
[Units: Participants]
 
3 months to < 2 years   24 
≥ 2 years to < 6 years   25 
≥ 6 years to < 18 years   56 
Gender 
[Units: Participants]
 
Female   47 
Male   58 
Race/Ethnicity, Customized 
[Units: Participants]
 
Asian   1 
Black or African Heritage   1 
White   99 
Other   2 
Not Permitted to be Recorded   2 
Race/Ethnicity, Customized 
[Units: Participants]
 
Hispanic   5 
Not Hispanic   93 
Not Permitted to be Recorded   7 
Region of Enrollment 
[Units: Participants]
 
France   12 
United States   56 
Spain   6 
Poland   3 
Belgium   11 
Austria   3 
Netherlands   5 
Germany   4 
Italy   5 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 24.8  (15.69) 
Height 
[Units: Cm]
Mean (Standard Deviation)
 113.9  (33.02) 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 17.1  (2.57) 
Presence of Pseudomonas aeruginosa (PA) [1] 
[Units: Participants]
 
Present at baseline   45 
Absent at baseline   57 
[1] Of the 105 participants in the safety analysis set, 3 participants did not provide baseline samples (ie, oropharyngeal swab sample). All participants had a positive PA culture within 30 days of baseline.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With PA-negative Cultures at All Time Points After Cessation of Active Treatment (Evaluable Analysis Set)   [ Time Frame: Day 28 to Day 196 ]

2.  Primary:   Percentage of Participants With PA-negative Cultures at All Time Points After Cessation of Active Treatment (Sensitivity Analysis Set)   [ Time Frame: Day 28 to Day 196 ]

3.  Secondary:   Change From Baseline in FEV1% Predicted   [ Time Frame: Baseline to Days 28, 56, 112, and 196 ]

4.  Secondary:   Change From Baseline in CFQ-R RSS Score   [ Time Frame: Baseline to Days 28, 56, 112, and 196 ]

5.  Secondary:   Percentage of Participants With PA-negative Cultures   [ Time Frame: Days 28, 56, 112, and 196 ]

6.  Secondary:   Use of Additional (Non-study) Antipseudomonal Antibiotics   [ Time Frame: Baseline to Day 196 ]

7.  Secondary:   Change From Baseline in Weight   [ Time Frame: Baseline to Days 28, 56, 112, and 196 ]

8.  Secondary:   Change From Baseline in Height   [ Time Frame: Baseline to Days 28, 56, 112, and 196 ]

9.  Secondary:   Change From Baseline in Body Mass Index (BMI)   [ Time Frame: Baseline to Days 28, 56, 112, and 196 ]

10.  Secondary:   Pharmacokinetics (PK) Peak and Trough Plasma Concentrations of Aztreonam   [ Time Frame: Day 1 (1 hour postdose) and Day 28 (immediately prior to dosing) ]


  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
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  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: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
e-mail: ClinicalTrialDisclosures@gilead.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01375049     History of Changes
Other Study ID Numbers: GS-US-205-0162
First Submitted: June 15, 2011
First Posted: June 17, 2011
Results First Submitted: May 29, 2014
Results First Posted: July 1, 2014
Last Update Posted: July 17, 2014