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

Sponsor:

Collaborators:

Chiltern International Inc.

ClinPhone, Inc.

Covance

Information provided by:

Gilead Sciences

Study Type	Interventional
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)
Arm/Group Description	AZLI (75 mg/1 mL aztreonam lysine w...	TIS (300 mg/5 mL) was self-administ...
Arm/Group Description	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
Arm/Group Description		AZLI (75 mg/1 mL aztreonam lysine w...	TIS (300 mg/5 mL) was self-administ...	Total of all reporting groups
Arm/Group Description		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
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
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
	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
	Number Analyzed	136 participants	132 participants	268 participants
	Female	68 50.0%	66 50.0%	134 50.0%
	Male	68 50.0%	66 50.0%	134 50.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	136 participants	132 participants	268 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	1 0.7%	0 0.0%	1 0.4%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	1 0.8%	1 0.4%
	White	130 95.6%	131 99.2%	261 97.4%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	5 3.7%	0 0.0%	5 1.9%
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
	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.
Forced Expiratory Volume (FEV1) Percent Predicted ^[1] Mean (Standard Deviation) Unit of measure: Percent
	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.
Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score ^[1] Mean (Standard Deviation) Unit of measure: Units on a scale
	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.

Outcome Measures

1.Primary Outcome


Title	Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28
Description	Spirometry was performed according to American Thoracic Society (ATS) ...
Description	Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested using an analysis of covariance (ANCOVA) model-based method.
Time Frame	Baseline and end of treatment Course 1 (Day 28)

Outcome Measure Data

Analysis Population Description

Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). The last observation carried forward (LOCF) method was used to impute missing data.


Arm/Group Title	AZLI (75 mg TID)	TIS (300 mg BID)
Arm/Group Description:	AZLI (75 mg/1 mL aztreonam lysine w...	TIS (300 mg/5 mL) was self-administ...
Arm/Group Description:	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.
Overall Number of Participants Analyzed	136	132
Least Squares Mean (Standard Error) Unit of Measure: percent change in FEV1 percent predicted
	8.35 (1.70)	0.55 (1.77)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZLI (75 mg TID), TIS (300 mg BID)
	Comments	Null hypothesis: AZLI was inferior to TIS by more than 4% in the mean relative change of FEV1 percent predicted at Day 28. With 120 subjects per treatment group there was at least 85% power to declare noninferiority based on relative change from baseline at Day 28 in FEV1 percent predicted using the upper bound of a 2-tailed 95% CI for the difference in means with a noninferiority margin of 4, assuming a common standard deviation of 18% and true difference in means [TIS-AZLI] of -3.2%.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The treatment difference (TIS-AZLI) and standard error from the ANCOVA model were used to compute the two-sided 95% confidence interval. If the 95% upper boundary was less than the pre-specified non-inferiority margin of 4%, then the null hypothesis was rejected.

Statistical Test of Hypothesis	P-Value	0.0001
	Comments	Based on the Benjamini & Hochberg method, non-inferiority at Day 28 for relative change in FEV1 percent predicted was assessed at the 0.05 level, given the significance of the coprimary endpoint (p<0.05).
	Method	ANCOVA
	Comments	ANCOVA model included treatment, Day 0 FEV1 percent predicted, and previous inhaled tobramycin use for all participants.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-7.80
	Confidence Interval	(2-Sided) 95% -11.73 to -3.86
	Estimation Comments	Treatment difference refers to TIS-AZLI.

2.Primary Outcome


Title	Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses
Description	Spirometry was performed...
Description	Spirometry was performed according to ATS guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the average adjusted means for the actual change in FEV1 percent predicted at Visits 4, 6, and 8 (Weeks 4, 12, and 20) was tested by mixed-effect model repeated measures (MMRM) analysis using the ITT population analysis set.
Time Frame	Baseline, and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)

Outcome Measure Data

Analysis Population Description

Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).


Arm/Group Title	AZLI (75 mg TID)	TIS (300 mg BID)
Arm/Group Description:	AZLI (75 mg/1 mL aztreonam lysine w...	TIS (300 mg/5 mL) was self-administ...
Arm/Group Description:	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.
Overall Number of Participants Analyzed	136	132
Least Squares Mean (Standard Error) Unit of Measure: actual change in FEV1 percent predicted
	2.05 (0.69)	-0.66 (0.72)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZLI (75 mg TID), TIS (300 mg BID)
	Comments	Null hypothesis: there was no difference between AZLI and TIS treatment groups in the mean actual change of FEV1 percent predicted across 3 treatment courses among all participants. With 120 subjects per treatment group, there was at least 90% power at a 5% significance level to detect differences based upon actual change from baseline in FEV1 percent predicted (3.61%, 2.98%, 2.32%) between AZLI and TIS at Weeks 4, 12, and 20 with a common standard deviation of 9%.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0023
	Comments	Based on the Benjamini & Hochberg method, superiority at Weeks 4, 12, and 20 of actual change in FEV1 percent predicted was tested at the 0.05 level, given the significance of the coprimary endpoint (p<0.05).
	Method	MMRM analysis
	Comments	MMRM analysis included Day 0 FEV1 percent predicted, previous inhaled tobramycin use, treatment, visit, and treatment/visit interaction.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.70
	Estimation Comments	Treatment difference refers to TIS-AZLI.

3.Secondary Outcome


Title	Relative Change From Baseline in FEV1 Percent Predicted at Day 28 in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization
Description	Spirometry was performed according to ATS guidelines. FEV1 percent pre...
Description	Spirometry was performed according to ATS guidelines. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested using an ANCOVA model-based method, using the population of participants with prior inhaled tobramycin use of >= 84 days in the previous 12 months.
Time Frame	Baseline and end of treatment Course 1 (Day 28)

Outcome Measure Data

Analysis Population Description

Analysis was based on participants with previous inhaled tobramycin use of >= 84 days within the previous 12 months using the ITT analysis set. The last observation carried forward (LOCF) method was used to impute missing data for statistical analyses.


Arm/Group Title	AZLI (75 mg TID)	TIS (300 mg BID)
Arm/Group Description:	AZLI (75 mg/1 mL aztreonam lysine w...	TIS (300 mg/5 mL) was self-administ...
Arm/Group Description:	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.
Overall Number of Participants Analyzed	115	113
Least Squares Mean (Standard Error) Unit of Measure: percent change in FEV1 percent predicted
	10.04 (1.56)	0.54 (1.57)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZLI (75 mg TID), TIS (300 mg BID)
	Comments	Null hypothesis: AZLI was inferior to TIS by more than 4% in terms of the participant means in relative change of FEV1 percent predicted at Day 28 among all participants having >= 84 days of inhaled tobramycin use in the previous 12 months.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The treatment difference (TIS-AZLI) and standard error from the ANCOVA model were used to compute the two-sided 95% confidence interval. If the 95% upper boundary was less than the pre-specified non-inferiority margin of 4%, then the null hypothesis was rejected.

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	Secondary endpoints were tested sequentially by the closed testing procedure initiated by the significance of the primary endpoints. Given the coprimary endpoints were met at the 0.05 level, this non-inferiority endpoint was tested at the 0.05 level.
	Method	ANCOVA
	Comments	ANCOVA model included treatment and Day 0 FEV1 percent predicted.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-9.50
	Confidence Interval	(2-Sided) 95% -13.86 to -5.14
	Estimation Comments	Treatment difference refers to TIS-AZLI.

4.Secondary Outcome


Title	Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization
Description	Spirometry was performed...
Description	Spirometry was performed according to ATS guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the average adjusted means for the actual change in FEV1 percent predicted at Visits 4, 6, and 8 (Weeks 4, 12, and 20) was tested by MMRM analysis using the population of participants with prior inhaled tobramycin use of >=84 days in the previous 12 months.
Time Frame	Baseline and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)

Outcome Measure Data

Analysis Population Description

Analysis was based on participants with prior inhaled tobramycin use >= 84 days in the previous 12 months using the ITT analysis set.


Arm/Group Title	AZLI (75 mg TID)	TIS (300 mg BID)
Arm/Group Description:	AZLI (75 mg/1 mL aztreonam lysine w...	TIS (300 mg/5 mL) was self-administ...
Arm/Group Description:	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.
Overall Number of Participants Analyzed	115	113
Least Squares Mean (Standard Error) Unit of Measure: actual change in FEV1 percent predicted
	3.26 (0.65)	-0.21 (0.66)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZLI (75 mg TID), TIS (300 mg BID)
	Comments	Null hypothesis: there was no difference between AZLI and TIS treatment groups in the mean actual change of FEV1 percent predicted across 3 treatment courses in the stratum of subjects having >=84 days of inhaled tobramycin use in the previous 12 months.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0002
	Comments	Secondary endpoints were tested sequentially to control the Type I error rate based on the closed testing procedure. Given the significance of the coprimary endpoints and previous secondary endpoint, this endpoint was also tested at the 0.05 level.
	Method	MMRM analysis
	Comments	MMRM analysis included treatment, Day 0 FEV1 percent predicted, visit, treatment, and treatment/visit interaction for all participants.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.47
	Estimation Comments	Treatment difference refers to TIS-AZLI

5.Secondary Outcome


Title	Time to Need for Intravenous (IV) Antipseudomonal Antibiotics for Respiratory Events
Description	IV antipseudomonal antib...
Description	IV antipseudomonal antibiotic use for a respiratory event was determined through the adjudication of events by a sponsor-independent, blinded review committee. Use was compiled from data recorded on the concomitant medications electronic case report form (eCRF) and compared to reported adverse events (AEs) to determine use for a respiratory event. The time to IV antipseudomonal antibiotic use was measured in days from baseline (Visit 2) to the date of first IV antipseudomonal antibiotic use or the date of study completion (last visit)/or early withdrawal if censored.
Time Frame	Day 0 to Day 168 (end of study)

Outcome Measure Data

Analysis Population Description

Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).


Arm/Group Title	AZLI (75 mg TID)	TIS (300 mg BID)
Arm/Group Description:	AZLI (75 mg/1 mL aztreonam lysine w...	TIS (300 mg/5 mL) was self-administ...
Arm/Group Description:	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.
Overall Number of Participants Analyzed	136	132
Median (95% Confidence Interval) Unit of Measure: days
	NA ^[1] (177 to NA)	151 ^[1] (113 to NA)

[1]

NA = Not estimable; less than 50% of the participants had an event by the end of the study.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZLI (75 mg TID), TIS (300 mg BID)
	Comments	Null hypothesis: there was no difference between AZLI and TIS treatment groups with respect to time to need for IV antipseudomonal antibiotics for respiratory events.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0025
	Comments	Secondary endpoints were tested sequentially to control the Type I error rate based on the closed testing procedure. Given the significance of the coprimary endpoints and previous secondary endpoint, this endpoint was also tested at the 0.05 level.
	Method	Log Rank
	Comments	[Not Specified]

6.Secondary Outcome


Title	Time to First Respiratory Hospitalization
Description	This endpoint was determ...
Description	This endpoint was determined through the adjudication of events by a sponsor-independent, blinded review committee. Committee members reviewed all hospitalizations and determined which were related to respiratory events. Details of all hospitalizations, including the dates of admission and discharge, were recorded on the serious adverse event (SAE) eCRF. Time to first respiratory hospitalization was the number of days from baseline (Visit 2) to the date of first respiratory hospitalization or the date of study completion (last visit) /or early withdrawal if censored.
Time Frame	Day 0 to Day 168 (end of study)

Outcome Measure Data

Analysis Population Description

Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).


Arm/Group Title	AZLI (75 mg TID)	TIS (300 mg BID)
Arm/Group Description:	AZLI (75 mg/1 mL aztreonam lysine w...	TIS (300 mg/5 mL) was self-administ...
Arm/Group Description:	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.
Overall Number of Participants Analyzed	136	132
Median (95% Confidence Interval) Unit of Measure: days
	NA ^[1] (NA to NA)	NA ^[1] (NA to NA)

[1]

NA = Not estimable; less than 50% of the participants had an event by the end of the study.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZLI (75 mg TID), TIS (300 mg BID)
	Comments	Null hypothesis: there was no difference between AZLI and TIS treatment groups with respect to time to first respiratory hospitalization.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.1114
	Comments	Secondary endpoints were tested sequentially to control the Type I error rate based on the closed testing procedure. Given the significance of the coprimary endpoints and previous secondary endpoint, this endpoint was also tested at the 0.05 level.
	Method	Log Rank
	Comments	[Not Specified]

7.Other Pre-specified Outcome


Title	Actual Change From Baseline in CF Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28
Description	The CFQ-R is a validated patient-reported outcome tool measuring healt...
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. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from baseline, assessed with the CFQ-R RSS (range of scores [units]: 0-100; higher scores indicate fewer symptoms).
Time Frame	Baseline and end of treatment Course 1 (Day 28)

Outcome Measure Data

Analysis Population Description

Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). LOCF method was used to impute missing data for statistical analyses.


Arm/Group Title	AZLI (75 mg TID)	TIS (300 mg BID)
Arm/Group Description:	AZLI (75 mg/1 mL aztreonam lysine w...	TIS (300 mg/5 mL) was self-administ...
Arm/Group Description:	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.
Overall Number of Participants Analyzed	136	132
Least Squares Mean (Standard Error) Unit of Measure: Units on a scale
	8.20 (1.68)	2.59 (1.73)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZLI (75 mg TID), TIS (300 mg BID)
	Comments	Null hypothesis: there was no difference between AZLI and TIS treatment groups in change from baseline in CFQ-R RSS scores at Day 28.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0048
	Comments	No adjustments were made for multiple comparisons.
	Method	ANCOVA
	Comments	ANCOVA model included treatment, Day 0 FEV1 percent predicted, Day 0 CFQ-R RSS score, and previous inhaled tobramycin use.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.61
	Estimation Comments	Treatment difference refers to TIS-AZLI.

8.Other Pre-specified Outcome


Title	Mean Actual Change From Baseline in CFQ-R RSS Score Across 3 Treatment Courses
Description	The CFQ-R is a validated patient-reported outcome tool measuring healt...
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. The endpoint was the average actual change in respiratory symptoms (e.g., coughing, congestion, wheezing) from baseline, assessed with the CFQ-R RSS (range of scores [units]: 0-100; higher scores indicate fewer symptoms) at the end of each treatment course (Weeks 4, 12, and 20).
Time Frame	Baseline and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)

Outcome Measure Data

Analysis Population Description

Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). The LOCF method was used to impute missing data for statistical purposes.


Arm/Group Title	AZLI (75 mg TID)	TIS (300 mg BID)
Arm/Group Description:	AZLI (75 mg/1 mL aztreonam lysine w...	TIS (300 mg/5 mL) was self-administ...
Arm/Group Description:	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.
Overall Number of Participants Analyzed	136	132
Least Squares Mean (Standard Error) Unit of Measure: units on a scale
	6.30 (1.49)	2.17 (1.54)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZLI (75 mg TID), TIS (300 mg BID)
	Comments	Null hypothesis: there was no difference between AZLI and TIS treatment groups in the average actual change in respiratory symptoms at the end of each treatment course (Weeks 4, 12, and 20).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0189
	Comments	No adjustments were made for multiple comparisons.
	Method	ANCOVA
	Comments	ANCOVA model included treatment, Day 0 FEV1 percent predicted, Day 0 CFQ-R RSS score, and previous inhaled tobramycin use.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.13
	Estimation Comments	Treatment difference refers to TIS-AZLI.

9.Other Pre-specified Outcome


Title	Treatment Satisfaction Questionnaire for Medication (TSQM) - Global Satisfaction Results at Week 20
Description	This 14 item questionnaire consists of 3 subscales that gauge particip...
Description	This 14 item questionnaire consists of 3 subscales that gauge participant perceptions of a medication's effectiveness, side effects, and convenience. The measure also contains a global satisfaction scale to evaluate overall participant satisfaction. The global satisfaction score is the endpoint reported here. The range of scores is 0 to 100, with higher scores indicating greater satisfaction.
Time Frame	At Week 20

Outcome Measure Data

Analysis Population Description

Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).


Arm/Group Title	AZLI (75 mg TID)	TIS (300 mg BID)
Arm/Group Description:	AZLI (75 mg/1 mL aztreonam lysine w...	TIS (300 mg/5 mL) was self-administ...
Arm/Group Description:	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.
Overall Number of Participants Analyzed	130	126
Least Squares Mean (Standard Error) Unit of Measure: units on a scale
	75.85 (4.58)	61.73 (4.90)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZLI (75 mg TID), TIS (300 mg BID)
	Comments	Null hypothesis: there was no difference between AZLI and TIS treatment groups in the global satisfaction results of the TSQM at Week 20 (Day 140).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0097
	Comments	No adjustments were made for multiple comparisons.
	Method	ANCOVA
	Comments	ANCOVA model included treatment, Day 0 FEV1 percent predicted, and previous inhaled tobramycin use.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-14.12
	Estimation Comments	Treatment difference refers to TIS-AZLI.

10.Other Pre-specified Outcome


Title	Total Number of Respiratory Hospitalizations
Description	Respiratory hospitalizations were determined through the adjudication ...
Description	Respiratory hospitalizations were determined through the adjudication of events by a sponsor-independent, blinded review committee. Committee members reviewed hospitalizations and determined which were related to respiratory events.
Time Frame	Day 0 to Day 168 (end of study)

Outcome Measure Data

Analysis Population Description

Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).


Arm/Group Title	AZLI (75 mg TID)	TIS (300 mg BID)
Arm/Group Description:	AZLI (75 mg/1 mL aztreonam lysine w...	TIS (300 mg/5 mL) was self-administ...
Arm/Group Description:	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.
Overall Number of Participants Analyzed	136	132
Measure Type: Number Unit of Measure: hospitalizations
	40	58

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZLI (75 mg TID), TIS (300 mg BID)
	Comments	Null hypothesis: there was no difference between AZLI and TIS treatment groups in the total number of respiratory hospitalizations from Day 0 to Day 168 (end of study).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.044
	Comments	No adjustments were made for multiple comparisons.
	Method	negative binomial regression method
	Comments	[Not Specified]

11.Other Pre-specified Outcome


Title	Number of Respiratory Events Requiring IV and/or Inhaled Antipseudomonal Antibiotics (Other Than Randomized Treatment)
Description	Inhaled and/or IV antipseudomonal antibiotic use for respiratory event...
Description	Inhaled and/or IV antipseudomonal antibiotic use for respiratory event was determined through event adjudication by a sponsor-independent, blinded review committee. Use of IV and/or inhaled antipseudomonal antibiotics was compiled from data recorded on the concomitant medications eCRF and compared to reported AEs to determine use for a respiratory event. The time to IV and/or inhaled antipseudomonal antibiotic use was measured in days from baseline (Visit 2) to the date of first antipseudomonal antibiotic use or the date of study completion (last visit)/or early withdrawal if censored.
Time Frame	Day 0 through Day 168 (end of study)

Outcome Measure Data

Analysis Population Description

Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).


Arm/Group Title	AZLI (75 mg TID)	TIS (300 mg BID)
Arm/Group Description:	AZLI (75 mg/1 mL aztreonam lysine w...	TIS (300 mg/5 mL) was self-administ...
Arm/Group Description:	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.
Overall Number of Participants Analyzed	136	132
Measure Type: Number Unit of Measure: events
	84	121

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZLI (75 mg TID), TIS (300 mg BID)
	Comments	Null hypothesis: there was no difference between AZLI and TIS treatment groups in the total number of respiratory events requiring IV and/or inhaled antipseudomonal antibiotics (other than randomized treatment) from Day 0 to Day 168 (end of study).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.004
	Comments	No adjustments were made for multiple comparisons.
	Method	negative binomial regression method
	Comments	[Not Specified]

12.Other Pre-specified Outcome


Title	Time to Need for Inhaled and/or IV Antipseudomonal Antibiotics for Respiratory Event (Other Than Randomized Treatment)
Description	Antipseudomonal antibiot...
Description	Antipseudomonal antibiotic use for respiratory event was determined through event adjudication by a sponsor-independent, blinded review committee. Use of IV and/or inhaled antibiotics for a respiratory event was compiled from data recorded on the concomitant medications eCRF and compared to reported AEs to determine use for a respiratory event. The time to antibiotic use for a respiratory event was measured in days from baseline (Day 0) to the date of first antibiotic use for a respiratory event or the date of study completion (last visit)/or early withdrawal if censored.
Time Frame	Day 0 to Day 168 (end of study)

Outcome Measure Data

Analysis Population Description

Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).


Arm/Group Title	AZLI (75 mg TID)	TIS (300 mg BID)
Arm/Group Description:	AZLI (75 mg/1 mL aztreonam lysine w...	TIS (300 mg/5 mL) was self-administ...
Arm/Group Description:	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.
Overall Number of Participants Analyzed	136	132
Median (95% Confidence Interval) Unit of Measure: days
	NA ^[1] (177 to NA)	117 (102 to 169)

[1]

NA = Not estimable; less than 50% of the participants had an event by the end of the study.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZLI (75 mg TID), TIS (300 mg BID)
	Comments	Null hypothesis: there was no difference between AZLI and TIS treatment groups with respect to time to need for inhaled and/or IV antipseudomonal antibiotics for respiratory events.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0004
	Comments	No adjustments were made for multiple comparisons.
	Method	Log Rank
	Comments	[Not Specified]

Adverse Events

Time Frame	Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24).
Adverse Event Reporting Description	An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.

Arm/Group Title	AZLI (75 mg TID)		TIS (300 mg BID)
Arm/Group Description	AZLI (75 mg/1 mL aztreonam lysine w...		TIS (300 mg/5 mL) was self-administ...
Arm/Group Description	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.
All-Cause Mortality
	AZLI (75 mg TID)		TIS (300 mg BID)
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	AZLI (75 mg TID)		TIS (300 mg BID)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	42/136 (30.88%)		44/132 (33.33%)
Cardiac disorders
Atrial Fibrillation ¹	0/136 (0.00%)	0	1/132 (0.76%)	1
Cyanosis ¹	0/136 (0.00%)	0	1/132 (0.76%)	1
Ear and labyrinth disorders
Vertigo ¹	0/136 (0.00%)	0	1/132 (0.76%)	1
Gastrointestinal disorders
Abdominal Discomfort ¹	1/136 (0.74%)	1	0/132 (0.00%)	0
Abdominal Distention ¹	0/136 (0.00%)	0	2/132 (1.52%)	2
Abdominal Pain ¹	5/136 (3.68%)	5	1/132 (0.76%)	1
Constipation ¹	1/136 (0.74%)	1	0/132 (0.00%)	0
Nausea ¹	1/136 (0.74%)	1	0/132 (0.00%)	0
Vomiting ¹	4/136 (2.94%)	4	0/132 (0.00%)	0
General disorders
Chest Discomfort ¹	1/136 (0.74%)	1	0/132 (0.00%)	0
Chest Pain ¹	3/136 (2.21%)	3	2/132 (1.52%)	2
Chills ¹	1/136 (0.74%)	1	0/132 (0.00%)	0
Exercise Tolerance Decreased ¹	6/136 (4.41%)	6	3/132 (2.27%)	3
Fatigue ¹	1/136 (0.74%)	1	3/132 (2.27%)	3
Malaise ¹	1/136 (0.74%)	1	0/132 (0.00%)	0
Oedema Peripheral ¹	0/136 (0.00%)	0	2/132 (1.52%)	2
Pain ¹	2/136 (1.47%)	2	0/132 (0.00%)	0
Pyrexia ¹	11/136 (8.09%)	13	8/132 (6.06%)	10
Infections and infestations
Catheter Related Infection ¹	1/136 (0.74%)	1	0/132 (0.00%)	0
Systemic Candida ¹	1/136 (0.74%)	1	0/132 (0.00%)	0
Injury, poisoning and procedural complications
Alcohol Poisoning ¹	1/136 (0.74%)	1	0/132 (0.00%)	0
Feeding Tube Complication ¹	1/136 (0.74%)	1	0/132 (0.00%)	0
Investigations
Body Temperature Increased ¹	0/136 (0.00%)	0	1/132 (0.76%)	1
Breath Sounds Abnormal ¹	1/136 (0.74%)	1	1/132 (0.76%)	1
C-Reactive Protein Increased ¹	1/136 (0.74%)	1	0/132 (0.00%)	0
Forced Expiratory Volume Decreased ¹	3/136 (2.21%)	3	0/132 (0.00%)	0
Glycosylated Haemoglobin Increased ¹	0/136 (0.00%)	0	1/132 (0.76%)	1
Oxygen Saturation Decreased ¹	0/136 (0.00%)	0	1/132 (0.76%)	2
Pulmonary Function Test Decreased ¹	5/136 (3.68%)	5	4/132 (3.03%)	4
Weight Decreased ¹	1/136 (0.74%)	1	2/132 (1.52%)	2
Metabolism and nutrition disorders
Decreased Appetite ¹	3/136 (2.21%)	3	2/132 (1.52%)	2
Diabetes Mellitus Inadequate Control ¹	2/136 (1.47%)	3	0/132 (0.00%)	0
Musculoskeletal and connective tissue disorders
Joint Swelling ¹	0/136 (0.00%)	0	1/132 (0.76%)	1
Muscle Spasms ¹	1/136 (0.74%)	1	0/132 (0.00%)	0
Pain in Extremity ¹	0/136 (0.00%)	0	1/132 (0.76%)	1
Nervous system disorders
Coma ¹	1/136 (0.74%)	1	0/132 (0.00%)	0
Headache ¹	1/136 (0.74%)	1	1/132 (0.76%)	1
Lethargy ¹	1/136 (0.74%)	2	0/132 (0.00%)	0
Poor Quality Sleep ¹	1/136 (0.74%)	1	0/132 (0.00%)	0
Sinus Headache ¹	1/136 (0.74%)	1	0/132 (0.00%)	0
Psychiatric disorders
Insomnia ¹	1/136 (0.74%)	1	0/132 (0.00%)	0
Renal and urinary disorders
Anuria ¹	0/136 (0.00%)	0	1/132 (0.76%)	1
Respiratory, thoracic and mediastinal disorders
Cough ¹	27/136 (19.85%)	31	26/132 (19.70%)	30
Dyspnoea ¹	10/136 (7.35%)	13	15/132 (11.36%)	17
Dyspnoea Exertional ¹	1/136 (0.74%)	1	1/132 (0.76%)	1
Haemoptysis ¹	5/136 (3.68%)	6	3/132 (2.27%)	4
Hypoxia ¹	1/136 (0.74%)	1	0/132 (0.00%)	0
Lung Infiltration ¹	0/136 (0.00%)	0	1/132 (0.76%)	1
Nasal Congestion ¹	1/136 (0.74%)	2	0/132 (0.00%)	0
Nasal Mucosal Disorder ¹	1/136 (0.74%)	1	0/132 (0.00%)	0
Oropharyngeal Pain ¹	4/136 (2.94%)	4	0/132 (0.00%)	0
Pleuritic Pain ¹	0/136 (0.00%)	0	2/132 (1.52%)	2
Productive Cough ¹	16/136 (11.76%)	21	23/132 (17.42%)	29
Rales ¹	2/136 (1.47%)	2	3/132 (2.27%)	3
Respiratory Tract Congestion ¹	1/136 (0.74%)	1	3/132 (2.27%)	3
Rhinorrhoea ¹	3/136 (2.21%)	3	0/132 (0.00%)	0
Rhonchi ¹	1/136 (0.74%)	1	0/132 (0.00%)	0
Sinus Congestion ¹	1/136 (0.74%)	1	0/132 (0.00%)	0
Sputum Discoloured ¹	2/136 (1.47%)	2	1/132 (0.76%)	1
Tachypnoea ¹	1/136 (0.74%)	1	2/132 (1.52%)	2
Wheezing ¹	3/136 (2.21%)	3	5/132 (3.79%)	5
Vascular disorders
Hyperaemia ¹	0/136 (0.00%)	0	1/132 (0.76%)	1
Vein Disorder ¹	0/136 (0.00%)	0	1/132 (0.76%)	1
1 Term from vocabulary, MedDRA (11.1)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	AZLI (75 mg TID)		TIS (300 mg BID)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	128/136 (94.12%)		127/132 (96.21%)
Gastrointestinal disorders
Abdominal Pain ¹	15/136 (11.03%)		8/132 (6.06%)
Diarrhoea ¹	4/136 (2.94%)		12/132 (9.09%)
Nausea ¹	13/136 (9.56%)		10/132 (7.58%)
Vomiting ¹	12/136 (8.82%)		14/132 (10.61%)
General disorders
Chest Discomfort ¹	13/136 (9.56%)		13/132 (9.85%)
Chest Pain ¹	6/136 (4.41%)		8/132 (6.06%)
Exercise Tolerance Decreased ¹	20/136 (14.71%)		24/132 (18.18%)
Fatigue ¹	23/136 (16.91%)		22/132 (16.67%)
Pain ¹	9/136 (6.62%)		4/132 (3.03%)
Pyrexia ¹	34/136 (25.00%)		36/132 (27.27%)
Investigations
Breath Sounds Abnormal ¹	7/136 (5.15%)		14/132 (10.61%)
Forced Expiratory Volume Decreased ¹	7/136 (5.15%)		5/132 (3.79%)
Pulmonary Function Test Decreased ¹	6/136 (4.41%)		15/132 (11.36%)
Metabolism and nutrition disorders
Decreased Appetite ¹	17/136 (12.50%)		17/132 (12.88%)
Musculoskeletal and connective tissue disorders
Arthalgia ¹	10/136 (7.35%)		2/132 (1.52%)
Back Pain ¹	7/136 (5.15%)		4/132 (3.03%)
Myalgia ¹	9/136 (6.62%)		6/132 (4.55%)
Nervous system disorders
Headache ¹	28/136 (20.59%)		27/132 (20.45%)
Respiratory, thoracic and mediastinal disorders
Cough ¹	92/136 (67.65%)		95/132 (71.97%)
Dysphonia ¹	5/136 (3.68%)		8/132 (6.06%)
Dyspnoea ¹	26/136 (19.12%)		28/132 (21.21%)
Haemoptysis ¹	30/136 (22.06%)		20/132 (15.15%)
Nasal Congestion ¹	29/136 (21.32%)		26/132 (19.70%)
Oropharyngeal Pain ¹	34/136 (25.00%)		37/132 (28.03%)
Productive Cough ¹	63/136 (46.32%)		67/132 (50.76%)
Rales ¹	29/136 (21.32%)		32/132 (24.24%)
Respiratory Tract Congestion ¹	15/136 (11.03%)		16/132 (12.12%)
Rhinitis ¹	4/136 (2.94%)		7/132 (5.30%)
Rhinorrhoea ¹	24/136 (17.65%)		33/132 (25.00%)
Sinus Congestion ¹	3/136 (2.21%)		8/132 (6.06%)
Wheezing ¹	13/136 (9.56%)		15/132 (11.36%)
1 Term from vocabulary, MedDRA (11.1)

Limitations and Caveats

[Not Specified]

More Information

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.

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

Layout table for Results Point of Contact information

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):

Assael BM, Pressler T, Bilton D, Fayon M, Fischer R, Chiron R, LaRosa M, Knoop C, McElvaney N, Lewis SA, Bresnik M, Montgomery AB, Oermann CM; AZLI Active Comparator Study Group. Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: a comparative efficacy trial. J Cyst Fibros. 2013 Mar;12(2):130-40. doi: 10.1016/j.jcf.2012.07.006. Epub 2012 Sep 15.

Layout table for additonal information

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

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