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The purpose of this research study was to determine if an experimental drug called Aztreonam for Inhalation Solution (AZLI) was safe and effective to treat Burkholderia lung infections in patients with cystic fibrosis (CF).
Spirometry was used to assess pulmonary function, and the revised Cystic Fibrosis Questionnaire (CFQ-R) was used to assess quality of life. The CFQ-R is a validated, patient-reported outcome tool used to measure health-related quality of life for children and adults with CF.
The study consisted of a 24-week randomized phase, and a 24-week open-label phase. Primary and secondary efficacy analyses were conducted for the 24-week randomized phase only. Safety data were collected for both the randomized and open-label phases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZLI | Experimental | Participants were randomized to receive AZLI for up to 24 weeks and may have continued to receive AZLI during the open-label phase for up to an additional 24 weeks. |
|
| Placebo | Placebo Comparator | Participants were randomized to receive placebo to match AZLI for up to 24 weeks and may have switched to AZLI during the open-label phase for up to 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZLI | Drug | Aztreonam for inhalation solution (AZLI; 75 mg aztreonam/52.5 mg lysine monohydrate) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer. |
| Measure | Description | Time Frame |
|---|---|---|
| AUCave of Relative Change in FEV1 % Predicted From Baseline to Week 24 | The relative change (AUCave) in FEV1 % predicted from baseline to Week 24 was analyzed. FEV1 % predicted is defined as FEV1 % of the patient divided by the average FEV1 % in the population for any person of similar age, sex and body composition. AUCave is the calculated area under the curve corrected for baseline and adjusted by the number of days on study through Week 24. | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Systemic and/or Inhaled Antibiotic Courses for Respiratory Events | The total number of systemic and/or inhaled antibiotic courses for respiratory events from baseline to Week 24 was analyzed. A single antibiotic course may represent the use of multiple antibiotics. | Baseline to Week 24 |
| AUCave of Change in CFQ-R RSS Scores From Baseline to Week 24 |
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Inclusion Criteria:
Male or female ≥ 6 years of age
Subjects with CF as diagnosed by one of the following:
Chronic infection with Burkholderia spp. defined by:
Concomitant aerosolized antibiotic treatment: subjects receiving intermittent (alternating month on/month off) aerosolized antibiotic treatment were eligible, but must have been at least 1 week into their off-treatment cycle at the time of baseline assessment. Subjects receiving continuous aerosolized antibiotic treatment were eligible without restriction on their aerosolized antibiotic treatment.
Chest radiograph, computed tomography (CT), or magnetic resonance imaging (MRI) (most recent, obtained within 90 days of screening) without significant acute findings (eg, infiltrates [lobar or diffuse interstitial], pleural effusion, pneumothorax), and no significant intercurrent illness; chronic, stable findings (eg, chronic scarring or atelectasis) were allowed.
Subjects (and parent/guardian as required) must have been able to provide written informed consent/assent prior to any study-related procedures,
Ability to perform reproducible pulmonary function tests
Sexually active females of childbearing potential must have agreed to use a highly effective method of contraception during heterosexual intercourse throughout the study period and for 30 days following discontinuation of study drug. A highly effective method of birth control was defined as a method that would result in a low failure rate (ie, less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), or a vasectomized partner.
Exclusion Criteria:
Administration of any investigational drug or use of any investigational device within 28 days of randomization/baseline and within six half-lives of the investigational drug (whichever is longer)
Administration of AZLI treatment within the 28 days prior to randomization/baseline
Known local or systemic hypersensitivity to monobactam antibiotics
History of lung transplantation
Abnormal renal or hepatic function results at most recent test within the previous 90 days, defined as:
Known portal hypertension or complications of CF hepatopathy
Positive urine pregnancy test (confirmed by serum pregnancy test) at screening; all women of childbearing potential were tested
Any female of childbearing potential who was lactating or not practicing a highly effective method of birth control as defined in the protocol
Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would have interfered with subject treatment, assessment or compliance with the protocol
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| Name | Affiliation | Role |
|---|---|---|
| Mark Bresnik, MD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | 36608 | United States | |||
102 participants were screened and 101 were randomized. Of those participants randomized, 100 received at least one dose of study drug, and comprise the Safety Analysis Set and the Full Analysis Set.
Participants were enrolled at 34 sites in the United States and 1 site in Canada. The first participant was screened on 22 February 2010. The last participant observation was on 28 December 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZLI | Aztreonam for inhalation solution (AZLI; 75 mg aztreonam/52.5 mg lysine monohydrate) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer. After the 24-week randomized phase, participants continued to receive AZLI during the open-label phase. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 24-Week Randomized Phase |
|
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| Placebo | Drug | Placebo to match AZLI (lactose and sodium chloride) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer. |
|
The change (AUCave) in CFQ-R RSS scores from baseline to Week 24 was analyzed. The range of scores (units) within the RSS domain is 0 to 100 with higher scores indicating fewer symptoms. |
| Baseline to Week 24 |
| AUCave of Relative Change From Baseline to Week 24 in FEV1 | The relative change (AUCave) from baseline to Week 24 in mean (SE) FEV1 was analyzed. FEV1 is defined as the maximal volume of air that can be exhaled in 1 second. | Baseline to Week 24 |
| AUCave of Relative Change From Baseline to Week 24 in FVC | The relative change (AUCave) from baseline to Week 24 in mean (SE) FVC was analyzed. FVC is defined as the volume of air that can forcibly be blown out after taking a full breath. | Baseline to Week 24 |
| AUCave of Relative Change From Baseline to Week 24 in FEF25-75 | The relative change (AUCave) from baseline to Week 24 in mean (SE) FEF25-75 was analyzed. FEF25-75 is defined as the forced expiratory flow from 25% to 75% of the FVC. | Baseline to Week 24 |
| AUCave of the Change From Baseline to Week 24 in Physical Functioning Score as Assessed by the CFQ-R | The change (AUCave) from baseline to Week 24 in the physical functioning score as assessed by the CFQ-R was analyzed. The range of scores (units) in the CFQ-R physical functioning domain is 0 to 100 with higher scores indicating better QOL. | Baseline to Week 24 |
| AUCave of the Change From Baseline to Week 24 in Weight Score as Assessed by the CFQ-R | The change (AUCave) from baseline to Week 24 in the weight score as assessed by the CFQ-R was analyzed. The range of scores (units) in the CFQ-R weight domain is 0 to 100 with higher scores indicating better QOL. | Baseline to Week 24 |
| AUCave of the Change From Baseline to Week 24 in Treatment Burden Score as Assessed by the CFQ-R | The change (AUCave) from baseline to Week 24 in the treatment burden score as assessed by the CFQ-R was analyzed. The range of scores (units) in the CFQ-R treatment burden domain is 0 to 100 with higher scores indicating better QOL. | Baseline to Week 24 |
| Change in BMI From Baseline to Week 24 | The change in BMI from baseline to Week 24 was analyzed. | Baseline to Week 24 |
| Change in Burkholderia Spp. CFU in Sputum From Baseline to Week 24 | The change in Burkholderia spp. CFU in sputum from baseline to Week 24 was analyzed. | Baseline to Week 24 |
| Percentage of Days Participants Used Antibiotics | The percentage of days participants used antibiotics from baseline to Week 24 was analyzed. Antibiotics ongoing at baseline or started on or after first dose date were included in the analysis. A single antibiotic course could represent the use of multiple antibiotics. Days of antibiotic use included unique days. | Baseline to Week 24 |
| Percent of Days Hospitalized | The percentage of days hospitalized from baseline to Week 24 was analyzed. | Baseline to Week 24 |
| Percentage of Missed School or Work Days | The percentage of days participants missed school or work from baseline to Week 24 was analyzed. | Baseline to Week 24 |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| Little Rock | Arkansas | 72205 | United States |
| Denver | Colorado | 80206 | United States |
| Hartford | Connecticut | 06102 | United States |
| Wilmington | Delaware | 19803 | United States |
| Jacksonville | Florida | 32207 | United States |
| Miami | Florida | 33136 | United States |
| Tampa | Florida | 33606 | United States |
| Glenview | Illinois | 60025 | United States |
| Boston | Massachusetts | 02115 | United States |
| Worcester | Massachusetts | 01605 | United States |
| Detroit | Michigan | 48201 | United States |
| Minneapolis | Minnesota | 55455 | United States |
| St Louis | Missouri | 63110 | United States |
| Las Vegas | Nevada | 89107 | United States |
| Morristown | New Jersey | 07962 | United States |
| New Brunswick | New Jersey | 08903 | United States |
| Albuquerque | New Mexico | 87131 | United States |
| New Hyde Park | New York | 11040 | United States |
| Chapel Hill | North Carolina | 27599 | United States |
| Akron | Ohio | 44308 | United States |
| Columbus | Ohio | 43205 | United States |
| Toledo | Ohio | 43606 | United States |
| Oklahoma City | Oklahoma | 73112 | United States |
| Portland | Oregon | 97239 | United States |
| Hershey | Pennsylvania | 17033 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Pittsburgh | Pennsylvania | 15201 | United States |
| Charleston | South Carolina | 29425 | United States |
| Columbia | South Carolina | 29203 | United States |
| Richmond | Virginia | 23298 | United States |
| Morgantown | West Virginia | 26506 | United States |
| Milwaukee | Wisconsin | 53201 | United States |
| Toronto | Ontario | M5B 1W8 | Canada |
| Placebo |
Placebo to match AZLI (lactose and sodium chloride) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer. After the 24-week randomized phase, participants switched to AZLI during the open-label phase. |
| Randomized and Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| 24-Week Open-Label Phase |
|
|
Full Analysis Set: participants were randomized and received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | AZLI | Aztreonam for inhalation solution (AZLI; 75 mg aztreonam/52.5 mg lysine monohydrate) was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer. |
| BG001 | Placebo | Placebo to match AZLI (lactose and sodium chloride) was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Forced expiratory volume in 1 second (FEV1) percent predicted | FEV1 % predicted is defined as FEV1 % of the patient divided by the average FEV1 % in the population for any person of similar age, sex and body composition. | Mean | Standard Deviation | percentage of FEV1 % predicted |
| ||||||||||||||
| FEV1 | FEV1 is defined as the maximal volume of air that can be exhaled in 1 second. | Mean | Standard Deviation | liters |
| ||||||||||||||
| Forced vital capacity (FVC) | FVC is defined as the volume of air that can forcibly be blown out after taking a full breath. | Mean | Standard Deviation | liters |
| ||||||||||||||
| Forced expiratory flow 25% to 75% (FEF25-75) | FEF25-75 is defined as the forced expiratory flow from 25% to 75% of the FVC. | Mean | Standard Deviation | liters per second |
| ||||||||||||||
| Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score | Respiratory symptoms (e.g., coughing, congestion, wheezing) were assessed with the CFQ-R Respiratory Symptoms Scale (RSS). The range of scores (units) is 0 to 100 with higher scores indicating fewer symptoms. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Burkholderia spp colony-forming units (CFU) in sputum | Participants in the Full Analysis Set with evaluable assessments for Burkholderia spp. CFU in sputum at baseline were analyzed, which included 30 in the AZLI group, 32 in the placebo group, and 62 total. | Mean | Standard Deviation | log_10 CFU per gram |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUCave of Relative Change in FEV1 % Predicted From Baseline to Week 24 | The relative change (AUCave) in FEV1 % predicted from baseline to Week 24 was analyzed. FEV1 % predicted is defined as FEV1 % of the patient divided by the average FEV1 % in the population for any person of similar age, sex and body composition. AUCave is the calculated area under the curve corrected for baseline and adjusted by the number of days on study through Week 24. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | percent change in FEV1% predicted | Baseline to Week 24 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Number of Systemic and/or Inhaled Antibiotic Courses for Respiratory Events | The total number of systemic and/or inhaled antibiotic courses for respiratory events from baseline to Week 24 was analyzed. A single antibiotic course may represent the use of multiple antibiotics. | Full Analysis Set | Posted | Number | antibiotic treatment courses | Baseline to Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUCave of Change in CFQ-R RSS Scores From Baseline to Week 24 | The change (AUCave) in CFQ-R RSS scores from baseline to Week 24 was analyzed. The range of scores (units) within the RSS domain is 0 to 100 with higher scores indicating fewer symptoms. | Participants in the Full Analysis Set with available change data were analyzed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUCave of Relative Change From Baseline to Week 24 in FEV1 | The relative change (AUCave) from baseline to Week 24 in mean (SE) FEV1 was analyzed. FEV1 is defined as the maximal volume of air that can be exhaled in 1 second. | Participants in the Full Analysis Set with available change data were analyzed. | Posted | Least Squares Mean | Standard Error | percent change in FEV1 (liters) | Baseline to Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUCave of Relative Change From Baseline to Week 24 in FVC | The relative change (AUCave) from baseline to Week 24 in mean (SE) FVC was analyzed. FVC is defined as the volume of air that can forcibly be blown out after taking a full breath. | Participants in the Full Analysis Set with available change data were analyzed. | Posted | Least Squares Mean | Standard Error | percent change in FVC (liters) | Baseline to Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUCave of Relative Change From Baseline to Week 24 in FEF25-75 | The relative change (AUCave) from baseline to Week 24 in mean (SE) FEF25-75 was analyzed. FEF25-75 is defined as the forced expiratory flow from 25% to 75% of the FVC. | Participants in the Full Analysis Set with available change data were analyzed. | Posted | Least Squares Mean | Standard Error | percent change in FEF25-75 (liters/sec) | Baseline to Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUCave of the Change From Baseline to Week 24 in Physical Functioning Score as Assessed by the CFQ-R | The change (AUCave) from baseline to Week 24 in the physical functioning score as assessed by the CFQ-R was analyzed. The range of scores (units) in the CFQ-R physical functioning domain is 0 to 100 with higher scores indicating better QOL. | Participants in the Full Analysis Set with available change data were analyzed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUCave of the Change From Baseline to Week 24 in Weight Score as Assessed by the CFQ-R | The change (AUCave) from baseline to Week 24 in the weight score as assessed by the CFQ-R was analyzed. The range of scores (units) in the CFQ-R weight domain is 0 to 100 with higher scores indicating better QOL. | Participants in the Full Analysis Set with available change data were analyzed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUCave of the Change From Baseline to Week 24 in Treatment Burden Score as Assessed by the CFQ-R | The change (AUCave) from baseline to Week 24 in the treatment burden score as assessed by the CFQ-R was analyzed. The range of scores (units) in the CFQ-R treatment burden domain is 0 to 100 with higher scores indicating better QOL. | Participants in the Full Analysis Set with available change data were analyzed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in BMI From Baseline to Week 24 | The change in BMI from baseline to Week 24 was analyzed. | Participants in the Full Analysis Set with available change data were analyzed. | Posted | Least Squares Mean | Standard Error | kg/m^2 | Baseline to Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Burkholderia Spp. CFU in Sputum From Baseline to Week 24 | The change in Burkholderia spp. CFU in sputum from baseline to Week 24 was analyzed. | Participants in the Full Analysis Set with available change data were analyzed. | Posted | Least Squares Mean | Standard Error | log_10 CFU per gram of sputum | Baseline to Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Days Participants Used Antibiotics | The percentage of days participants used antibiotics from baseline to Week 24 was analyzed. Antibiotics ongoing at baseline or started on or after first dose date were included in the analysis. A single antibiotic course could represent the use of multiple antibiotics. Days of antibiotic use included unique days. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | percentage of days | Baseline to Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Days Hospitalized | The percentage of days hospitalized from baseline to Week 24 was analyzed. | Full Analysis Set | Posted | Mean | Standard Deviation | percentage of days | Baseline to Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Missed School or Work Days | The percentage of days participants missed school or work from baseline to Week 24 was analyzed. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | percentage of days | Baseline to Week 24 |
|
|
Baseline to Week 24
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZLI | For the reporting of Adverse Events, this group includes participants who were randomized to receive AZLI at baseline, and were analyzed from Baseline to Week 24. | 17 | 48 | 46 | 48 | ||
| EG001 | Placebo | For the reporting of Adverse Events, this group includes participants who were randomized to receive placebo at baseline, and were analyzed from Baseline to Week 24. | 21 | 52 | 46 | 52 | ||
| EG002 | AZLI/AZLI | For the reporting of Adverse Events, this group includes participants who were randomized to receive AZLI at baseline and continued to receive an up to an additional 24 weeks of AZLI treatment during the open-label phase, and were analyzed from Week 24 to Week 48. | 19 | 39 | 39 | 39 | ||
| EG003 | Placebo/AZLI | For the reporting of Adverse Events, this group includes participants who were randomized to receive placebo at baseline and switched AZLI for up to 24 weeks of treatment during the open-label phase, and were analyzed from Week 24 to Week 48. | 24 | 45 | 44 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Infective pulmonary exacerbation of cycstic fibrosis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Arthritis reactive | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cholethiasis | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Pulmonary function test decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haematspermia | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Exercise tolerance decreased | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Forced expiratory volume decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Increased viscosity of bronchial secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Paranasal sinus hypersectretion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pulmonary function test decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Rhinorrheoa | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Sputum increased | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Upper airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Painful respiration | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Post-tussive vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Breath sounds abmormal | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Vitamin D decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
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:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences, Inc. | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D019121 | Burkholderia Infections |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| Withdrawal by Subject |
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| Subject noncompliance |
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| Unable to clean device (hospitalization) |
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| Pulmonologist/participant decision |
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| > 12 to < 18 years |
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| ≥ 18 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| White |
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| Other |
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| Canada |
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| No |
| Superiority or Other |
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