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Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis (AIR-BX1)

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ClinicalTrials.gov Identifier: NCT01313624
Recruitment Status : Completed
First Posted : March 14, 2011
Results First Posted : April 16, 2014
Last Update Posted : April 16, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Bronchiectasis
Interventions Drug: AZLI
Drug: Placebo
Enrollment 266
Recruitment Details Subjects were enrolled in a total of 57 study sites in the United States, Canada, and Australia. The first participant was screened on 25 April 2011. The last participant observation was on 04 June 2013.
Pre-assignment Details 348 participants were screened and 266 were randomized and treated, and comprise the Safety Analysis Set and the Intent-to-Treat (ITT) Analysis Set.
Arm/Group Title AZLI-AZLI Placebo-AZLI
Hide Arm/Group Description Participants were randomized to receive blinded Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up. Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
Period Title: Double-Blind Phase
Started 134 132
Completed 96 122
Not Completed 38 10
Reason Not Completed
Adverse Event             27             4
Withdrawal by Subject             9             4
Lost to Follow-up             0             2
Physician Decision             1             0
Lack of Efficacy             1             0
Period Title: Open-Label Phase
Started 96 122
Completed 92 109
Not Completed 4 13
Reason Not Completed
Adverse Event             1             10
Withdrawal by Subject             2             2
Lost to Follow-up             1             1
Arm/Group Title AZLI-AZLI Placebo-AZLI Total
Hide Arm/Group Description Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up. Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up. Total of all reporting groups
Overall Number of Baseline Participants 134 132 266
Hide Baseline Analysis Population Description
ITT Analysis Set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 134 participants 132 participants 266 participants
64.2  (12.92) 64.9  (12.11) 64.6  (12.51)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants 132 participants 266 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
53
  39.6%
54
  40.9%
107
  40.2%
>=65 years
81
  60.4%
78
  59.1%
159
  59.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants 132 participants 266 participants
Female
84
  62.7%
97
  73.5%
181
  68.0%
Male
50
  37.3%
35
  26.5%
85
  32.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants 132 participants 266 participants
Hispanic or Latino
12
   9.0%
11
   8.3%
23
   8.6%
Not Hispanic or Latino
121
  90.3%
121
  91.7%
242
  91.0%
Unknown or Not Reported
1
   0.7%
0
   0.0%
1
   0.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 134 participants 132 participants 266 participants
White 121 119 240
African-American 3 6 9
Asian 5 3 8
American Indian or Alaska Native 1 0 1
Other 4 3 7
Not Permitted 0 1 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 134 participants 132 participants 266 participants
United States 86 79 165
Canada 17 11 28
Australia 31 42 73
QOL-B Respiratory Symptom Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 134 participants 132 participants 266 participants
55.0  (19.32) 55.5  (19.26) 55.2  (19.26)
[1]
Measure Description: The Quality of Life Questionnaire-Bronchiectasis (QOL-B) overall score was scaled from 0-100 with higher scores representing better quality of life.
1.Primary Outcome
Title Change in QOL-B Respiratory Symptoms Score at Day 28
Hide Description The mean (SD) change in the Respiratory Symptoms score on the Quality of Life Questionnaire-Bronchiectasis (QOL-B) was measured from baseline to the end of Course 1 (Day 28). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.
Time Frame Baseline to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with scores at both baseline and Day 28 were analyzed.
Arm/Group Title AZLI-AZLI Placebo-AZLI
Hide Arm/Group Description:
Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
Overall Number of Participants Analyzed 117 124
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.4  (21.37) 5.7  (13.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZLI-AZLI, Placebo-AZLI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments P-value was based on T-test from mixed-effect model repeated measures (MMRM).
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares mean
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
-3.1 to 4.7
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in QOL-B Respiratory Symptoms Score at Day 84
Hide Description The mean (SD) change in the Respiratory Symptoms score on the QOL-B was measured from baseline to the end of Course 2 (Day 84). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.
Time Frame Baseline to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with scores at both baseline and Day 84 were analyzed.
Arm/Group Title AZLI-AZLI Placebo-AZLI
Hide Arm/Group Description:
Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
Overall Number of Participants Analyzed 108 122
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.4  (21.67) 4.7  (17.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZLI-AZLI, Placebo-AZLI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments P-value was based on T-test from mixed-effect model repeated measures (MMRM).
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares mean
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
-3.0 to 5.6
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time to Protocol-Defined Exacerbation (PDE)
Hide Description

Protocol-defined exacerbation was defined as an acute worsening of respiratory disease that triggered the initiation of a non-study antibiotic meeting at least 3 major criteria, or 2 major and at least 2 minor criteria.

  • Major Criteria: increased sputum production; increased discoloration of sputum; increased dyspnea; increased cough
  • Minor Criteria: fever (> 38º C) measured during clinic visit; increased malaise or fatigue; forced expiratory volume in 1 second (FEV1) (L) or forced vital capacity (FVC) decreased > 10% from baseline; new or increased hemoptysis
Time Frame Baseline to Day 112
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title AZLI-AZLI Placebo-AZLI
Hide Arm/Group Description:
Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
Overall Number of Participants Analyzed 134 132
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
120 [2] 
(117.0 to NA)
[1]
At least 50% of participants must have had a PDE in order to compute the median days to PDE. Fewer than 50% of participants in this group had a PDE, so median days to PDE could not be computed.
[2]
The 95% upper confidence interval (CI) could not be estimated due to an insufficient number of PDE events.
Time Frame Baseline up to 30 days after the last dose of study drug.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AZLI-AZLI (Double-Blind) Placebo-AZLI (Double-Blind) AZLI-AZLI (Open-Label) Placebo-AZLI (Open-Label)
Hide Arm/Group Description Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up. Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind placebo; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up. Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up. Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
All-Cause Mortality
AZLI-AZLI (Double-Blind) Placebo-AZLI (Double-Blind) AZLI-AZLI (Open-Label) Placebo-AZLI (Open-Label)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AZLI-AZLI (Double-Blind) Placebo-AZLI (Double-Blind) AZLI-AZLI (Open-Label) Placebo-AZLI (Open-Label)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   28/134 (20.90%)   13/132 (9.85%)   9/96 (9.38%)   18/122 (14.75%) 
Cardiac disorders         
Atrial fibrillation  1  1/134 (0.75%)  1/132 (0.76%)  0/96 (0.00%)  2/122 (1.64%) 
Tachycardia  1  1/134 (0.75%)  0/132 (0.00%)  0/96 (0.00%)  1/122 (0.82%) 
Cardiac arrest  1  0/134 (0.00%)  1/132 (0.76%)  0/96 (0.00%)  0/122 (0.00%) 
Coronary artery disease  1  0/134 (0.00%)  0/132 (0.00%)  0/96 (0.00%)  1/122 (0.82%) 
Gastrointestinal disorders         
Gastrointestinal ulcer haemorrhage  1  1/134 (0.75%)  0/132 (0.00%)  0/96 (0.00%)  0/122 (0.00%) 
Small intestinal obstruction  1  0/134 (0.00%)  0/132 (0.00%)  1/96 (1.04%)  0/122 (0.00%) 
Abdominal pain  1  0/134 (0.00%)  0/132 (0.00%)  0/96 (0.00%)  1/122 (0.82%) 
General disorders         
Pyrexia  1  2/134 (1.49%)  0/132 (0.00%)  0/96 (0.00%)  0/122 (0.00%) 
Gait disturbance  1  0/134 (0.00%)  1/132 (0.76%)  0/96 (0.00%)  0/122 (0.00%) 
Systemic inflammatory response syndrome  1  0/134 (0.00%)  0/132 (0.00%)  1/96 (1.04%)  0/122 (0.00%) 
Non-cardiac chest pain  1  0/134 (0.00%)  0/132 (0.00%)  0/96 (0.00%)  1/122 (0.82%) 
Immune system disorders         
Hypersensitivity  1  1/134 (0.75%)  0/132 (0.00%)  0/96 (0.00%)  0/122 (0.00%) 
Drug hypersensitivity  1  1/134 (0.75%)  0/132 (0.00%)  0/96 (0.00%)  0/122 (0.00%) 
Type IV hypersensitivity reaction  1  0/134 (0.00%)  0/132 (0.00%)  0/96 (0.00%)  1/122 (0.82%) 
Infections and infestations         
Infective exacerbation of bronchiectasis  1  5/134 (3.73%)  4/132 (3.03%)  5/96 (5.21%)  7/122 (5.74%) 
Pneumonia  1  5/134 (3.73%)  1/132 (0.76%)  2/96 (2.08%)  6/122 (4.92%) 
Bronchitis  1  0/134 (0.00%)  1/132 (0.76%)  0/96 (0.00%)  0/122 (0.00%) 
Bronchopneumonia  1  0/134 (0.00%)  1/132 (0.76%)  0/96 (0.00%)  0/122 (0.00%) 
Lung infection pseudomonal  1  1/134 (0.75%)  0/132 (0.00%)  0/96 (0.00%)  0/122 (0.00%) 
Infected skin ulcer  1  0/134 (0.00%)  1/132 (0.76%)  0/96 (0.00%)  0/122 (0.00%) 
Sinusitis  1  1/134 (0.75%)  0/132 (0.00%)  0/96 (0.00%)  0/122 (0.00%) 
Urinary tract infection  1  1/134 (0.75%)  0/132 (0.00%)  0/96 (0.00%)  0/122 (0.00%) 
Acute sinusitis  1  0/134 (0.00%)  0/132 (0.00%)  1/96 (1.04%)  0/122 (0.00%) 
Injury, poisoning and procedural complications         
Femur fracture  1  0/134 (0.00%)  1/132 (0.76%)  0/96 (0.00%)  0/122 (0.00%) 
Femoral neck fracture  1  0/134 (0.00%)  0/132 (0.00%)  0/96 (0.00%)  1/122 (0.82%) 
Investigations         
Electrocardiogram abnormal  1  0/134 (0.00%)  1/132 (0.76%)  0/96 (0.00%)  0/122 (0.00%) 
Metabolism and nutrition disorders         
Dehydration  1  2/134 (1.49%)  0/132 (0.00%)  0/96 (0.00%)  0/122 (0.00%) 
Diabetic ketoacidosis  1  1/134 (0.75%)  0/132 (0.00%)  0/96 (0.00%)  0/122 (0.00%) 
Musculoskeletal and connective tissue disorders         
Intervertebral disc degeneration  1  1/134 (0.75%)  0/132 (0.00%)  0/96 (0.00%)  0/122 (0.00%) 
Intervertebral disc protrusion  1  0/134 (0.00%)  1/132 (0.76%)  0/96 (0.00%)  0/122 (0.00%) 
Back pain  1  1/134 (0.75%)  0/132 (0.00%)  0/96 (0.00%)  0/122 (0.00%) 
Nervous system disorders         
Orthostatic intolerance  1  1/134 (0.75%)  0/132 (0.00%)  0/96 (0.00%)  0/122 (0.00%) 
Haemorrhage intracranial  1  0/134 (0.00%)  1/132 (0.76%)  0/96 (0.00%)  0/122 (0.00%) 
Memory impairment  1  0/134 (0.00%)  1/132 (0.76%)  0/96 (0.00%)  0/122 (0.00%) 
Cognitive disorder  1  0/134 (0.00%)  1/132 (0.76%)  0/96 (0.00%)  0/122 (0.00%) 
Dizziness  1  0/134 (0.00%)  1/132 (0.76%)  0/96 (0.00%)  0/122 (0.00%) 
Transient ischaemic attack  1  0/134 (0.00%)  1/132 (0.76%)  0/96 (0.00%)  0/122 (0.00%) 
Renal and urinary disorders         
Renal failure acute  1  0/134 (0.00%)  0/132 (0.00%)  0/96 (0.00%)  2/122 (1.64%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  3/134 (2.24%)  1/132 (0.76%)  0/96 (0.00%)  0/122 (0.00%) 
Bronchospasm  1  3/134 (2.24%)  0/132 (0.00%)  1/96 (1.04%)  0/122 (0.00%) 
Asthma  1  2/134 (1.49%)  0/132 (0.00%)  0/96 (0.00%)  0/122 (0.00%) 
Dyspnoea  1  2/134 (1.49%)  1/132 (0.76%)  0/96 (0.00%)  0/122 (0.00%) 
Cough  1  1/134 (0.75%)  0/132 (0.00%)  0/96 (0.00%)  0/122 (0.00%) 
Haemoptysis  1  1/134 (0.75%)  0/132 (0.00%)  0/96 (0.00%)  0/122 (0.00%) 
Sputum increased  1  1/134 (0.75%)  0/132 (0.00%)  0/96 (0.00%)  0/122 (0.00%) 
Lung disorder  1  1/134 (0.75%)  1/132 (0.76%)  1/96 (1.04%)  0/122 (0.00%) 
Hypoxia  1  1/134 (0.75%)  0/132 (0.00%)  0/96 (0.00%)  0/122 (0.00%) 
Pulmonary oedema  1  1/134 (0.75%)  0/132 (0.00%)  0/96 (0.00%)  0/122 (0.00%) 
Acute respiratory failure  1  1/134 (0.75%)  0/132 (0.00%)  0/96 (0.00%)  1/122 (0.82%) 
Skin and subcutaneous tissue disorders         
Dermatitis  1  1/134 (0.75%)  0/132 (0.00%)  0/96 (0.00%)  0/122 (0.00%) 
Vascular disorders         
Deep vein thrombosis  1  0/134 (0.00%)  0/132 (0.00%)  0/96 (0.00%)  1/122 (0.82%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AZLI-AZLI (Double-Blind) Placebo-AZLI (Double-Blind) AZLI-AZLI (Open-Label) Placebo-AZLI (Open-Label)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   116/134 (86.57%)   102/132 (77.27%)   54/96 (56.25%)   76/122 (62.30%) 
Gastrointestinal disorders         
Nausea  1  13/134 (9.70%)  11/132 (8.33%)  0/96 (0.00%)  0/122 (0.00%) 
Vomiting  1  7/134 (5.22%)  6/132 (4.55%)  0/96 (0.00%)  0/122 (0.00%) 
Diarrhoea  1  10/134 (7.46%)  12/132 (9.09%)  0/96 (0.00%)  0/122 (0.00%) 
General disorders         
Fatigue  1  56/134 (41.79%)  29/132 (21.97%)  22/96 (22.92%)  19/122 (15.57%) 
Malaise  1  11/134 (8.21%)  14/132 (10.61%)  5/96 (5.21%)  5/122 (4.10%) 
Pyrexia  1  32/134 (23.88%)  16/132 (12.12%)  7/96 (7.29%)  12/122 (9.84%) 
Non-cardiac chest pain  1  20/134 (14.93%)  14/132 (10.61%)  6/96 (6.25%)  8/122 (6.56%) 
Chills  1  18/134 (13.43%)  6/132 (4.55%)  6/96 (6.25%)  3/122 (2.46%) 
Oedema peripheral  1  7/134 (5.22%)  6/132 (4.55%)  0/96 (0.00%)  0/122 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1  8/134 (5.97%)  5/132 (3.79%)  0/96 (0.00%)  0/122 (0.00%) 
Nervous system disorders         
Headache  1  21/134 (15.67%)  23/132 (17.42%)  5/96 (5.21%)  7/122 (5.74%) 
Sinus headache  1  8/134 (5.97%)  2/132 (1.52%)  0/96 (0.00%)  0/122 (0.00%) 
Dizziness  1  10/134 (7.46%)  6/132 (4.55%)  0/96 (0.00%)  0/122 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  69/134 (51.49%)  57/132 (43.18%)  35/96 (36.46%)  50/122 (40.98%) 
Sputum Increased  1  62/134 (46.27%)  48/132 (36.36%)  29/96 (30.21%)  36/122 (29.51%) 
Sputum discoloured  1  42/134 (31.34%)  33/132 (25.00%)  24/96 (25.00%)  26/122 (21.31%) 
Haemoptysis  1  8/134 (5.97%)  12/132 (9.09%)  5/96 (5.21%)  9/122 (7.38%) 
Dyspnoea  1  73/134 (54.48%)  47/132 (35.61%)  31/96 (32.29%)  47/122 (38.52%) 
Oropharyngeal pain  1  14/134 (10.45%)  17/132 (12.88%)  4/96 (4.17%)  7/122 (5.74%) 
Rhinorrhoea  1  6/134 (4.48%)  7/132 (5.30%)  0/96 (0.00%)  0/122 (0.00%) 
Dysphonia  1  4/134 (2.99%)  7/132 (5.30%)  0/96 (0.00%)  0/122 (0.00%) 
Wheezing  1  21/134 (15.67%)  14/132 (10.61%)  6/96 (6.25%)  13/122 (10.66%) 
Nasal congestion  1  10/134 (7.46%)  7/132 (5.30%)  0/96 (0.00%)  0/122 (0.00%) 
Respiratory tract congestion  1  14/134 (10.45%)  3/132 (2.27%)  6/96 (6.25%)  5/122 (4.10%) 
Sinus congestion  1  7/134 (5.22%)  7/132 (5.30%)  0/96 (0.00%)  0/122 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
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 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
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Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
EMail: ClinicalTrialDisclosures@gilead.com
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01313624     History of Changes
Other Study ID Numbers: GS-US-219-0101
First Submitted: March 10, 2011
First Posted: March 14, 2011
Results First Submitted: March 7, 2014
Results First Posted: April 16, 2014
Last Update Posted: April 16, 2014