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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000398-11 | EudraCT Number |
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The primary objective of this study is to evaluate the safety and efficacy of a CAT regimen with aztreonam for inhalation solution (AZLI) and tobramycin inhalation solution (TIS) in adult and pediatric subjects with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection. Participants will be enrolled in a 28 day TIS run-in phase, and will be eligible for randomization in the comparative phase if they have not received non-study oral antibiotics for a respiratory event, or IV or inhaled antibiotics for any indication between Visits 2 and 3, have not developed a condition requiring hospitalization or other change in clinical status which, in the opinion of the investigator would preclude their ability to continue in the study, and have demonstrated at least 50% TIS compliance. Participants enrolled in the comparative phase will be randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI or placebo for 28 days followed by TIS for 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZLI | Active Comparator | Participants will be randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI for 28 days followed by TIS for 28 days. |
|
| Placebo | Placebo Comparator | Participants will be randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZLI | Drug | Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily combined with diluent administered using an eFlow nebulizer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Protocol-defined Exacerbations (PDE) From Baseline Through Week 24 | PDEs were characterized by a change or worsening from baseline of 1 or more documented signs or symptoms (decreased exercise tolerance, increased cough, increased sputum or chest congestion, decreased appetite, or other signs or symptoms) associated with the use of non-study IV or inhaled antibiotics and be verified by a blinded independent adjudication committee. | Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Average Actual Change From Baseline in FEV1 % Predicted Across All Courses of AZLI/Placebo Treatment (Weeks 4, 12 and 20) | 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. The adjusted mean is from a mixed-effect model repeated measures (MMRM) analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Bresnik, MD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Phoenix Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27233377 | Derived | Flume PA, Clancy JP, Retsch-Bogart GZ, Tullis DE, Bresnik M, Derchak PA, Lewis SA, Ramsey BW. Continuous alternating inhaled antibiotics for chronic pseudomonal infection in cystic fibrosis. J Cyst Fibros. 2016 Nov;15(6):809-815. doi: 10.1016/j.jcf.2016.05.001. Epub 2016 May 24. |
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Following enrollment, participants received tobramycin inhalation solution (TIS) in the TIS Run-In Phase, and if still eligible were randomized 1 to 1 to receive aztreonam for inhalation solution (AZLI) or placebo to match AZLI alternating with TIS in the Comparative Phase.
Participants were enrolled at study sites in the United States. The first participant was screened on 13 December 2012. The last study visit occurred on 15 January 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | TIS Run-In Treatment Group | Enrolled participants received 28 days of TIS (300 mg 2 times daily) during the run-in phase. |
| FG001 | AZLI | Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Run-in Phase |
|
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| Placebo to match AZLI | Drug | Placebo to match AZLI 3 times daily combined with diluent administered using an eFlow nebulizer |
|
| Tobramycin inhalation solution | Drug | Tobramycin inhalation solution (TIS) 300 mg 2 times daily using a PARI® LC Plus nebulizer and DeVilbiss Pulmo-Aide® air compressor |
|
|
| Comparative Phase: Baseline and Weeks 4, 12 and 20 |
| Percentage of Participants Who Used Non-study IV or Inhaled Antibiotics for PDEs | Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days) |
| Time to First Protocol-defined Pulmonary Exacerbation | The time to first protocol-defined pulmonary exacerbation was calculated using the Kaplan-Meier method. | Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days) |
| Rate of Hospitalizations for a Respiratory Event | The rate of hospitalizations for a respiratory event per participant year was calculated using negative binomial regression analysis. | Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days) |
| Average Change From Baseline in the CFQ-R Respiratory Symptom Scale (RSS) Score Across All Courses of AZLI/Placebo Treatment (Weeks 4, 12 and 20) | Respiratory symptoms (eg, coughing, congestion, wheezing) were assessed with the Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS). The range of scores (units) was 0 to 100 with higher scores indicating fewer symptoms. The adjusted mean is from a mixed-effect model repeated measures (MMRM) analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction. | Comparative Phase: Baseline and Weeks 4, 12 and 20 |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| University of California - San Diego | La Jolla | California | 92093 | United States |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| Kaiser Permanente Medical Center | Oakland | California | 94611 | United States |
| National Jewish Health | Denver | Colorado | 80206 | United States |
| Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Central Florida Pulmonary Group | Altamonte Springs | Florida | 32701 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| South Broward Hospital dba Memorial Healthcare System | Hollywood | Florida | 33021 | United States |
| Nemours Children's Clinic - Jacksonville | Jacksonville | Florida | 32207 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Nemours Children's Clinic - Orlando | Orlando | Florida | 32801 | United States |
| Arnold Palmer Hospital for Children | Orlando | Florida | 32806 | United States |
| Nemour's Children's Clinic | Pensacola | Florida | 32504 | United States |
| All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Emory Cystic Fibrosis Center | Atlanta | Georgia | 30084 | United States |
| Georgia Health | Augusta | Georgia | 30912 | United States |
| St. Lukes Medical Center | Boise | Idaho | 37012 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Chicago CF Care Specialists NFP dba Cystic Fibrosis Institure | Glenview | Illinois | 60025 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Maine Medical Center | Portland | Maine | 38103 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Harper University Hospital | Detroit | Michigan | 48201 | United States |
| Spectrum Health - Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| St. Louis University - Cardinal Glennon Children's Hospital | St Louis | Missouri | 63104 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Children's Lung Specialists | Las Vegas | Nevada | 89107 | United States |
| Dartmouth Hitchcock Specialty Care Clinic | Bedford | New Hampshire | 03110 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07962 | United States |
| UNM Clinical and Translational Center | Albuquerque | New Mexico | 87131 | United States |
| Albany Medical College | Albany | New York | 12208 | United States |
| Long Island Jewish Medical Center - Adult CF & Bronchiectasis Center | New Hyde Park | New York | 11042 | United States |
| Gunnar Esiason Adult CF and Lung Program | New York | New York | 10032 | United States |
| SUNY Upstate University | Syracuse | New York | 13210 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Akron Children's Hospital | Akron | Ohio | 44308 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| UC Health - University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| The Toledo Hospital/Toledo Children's Hospital CF Center | Toledo | Ohio | 43606 | United States |
| OU Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Santiago Reyes, MD | Oklahoma City | Oklahoma | 73112 | United States |
| Geisinger Clinic | Danville | Pennsylvania | 17822 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | 19107 | United States |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| East Tennessee Children's Hospital | Knoxville | Tennessee | 37916 | United States |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | United States |
| Children's Foundation Research Institute/UTHSC | Memphis | Tennessee | 28103 | United States |
| Vanderbilt Children's Hospital | Nashville | Tennessee | 37232 | United States |
| Austin Children's Chest Associates | Austin | Texas | 78723 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| Alamo Clinical Research Associates | San Antonio | Texas | 78212 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| Vermont Lung Center at the University of Vermont | Colchester | Vermont | 05446 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Children's Hospital of the King's Daughters | Norfolk | Virginia | 23510 | United States |
| VCU Children's Hospital | Richmond | Virginia | 23298 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53201 | United States |
| FG002 | Placebo | Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Comparative Phase |
|
|
Intent-to-Treat (ITT) Analysis Set: all randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AZLI | Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days. |
| BG001 | Placebo | Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days. |
| 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 |
| ||||||||||||||||
| FEV1 % predicted at Day 1 | Forced expiratory volume (FEV)1 is defined as the maximal volume of air that can be exhaled in 1 second. FEV1 % predicted is defined as FEV1 of the participant divided by the average FEV1 in the population for any person of similar age, sex, race, and body composition. | Mean | Standard Deviation | percentage of FEV1 % predicted |
| ||||||||||||||
| CFQ-R Respiratory Score at Day 1 | Respiratory symptoms (eg, coughing, congestion, wheezing) were assessed with the Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS). The range of scores (units) was 0 to 100 with higher scores indicating fewer symptoms. | Mean | Standard Deviation | units on a scale |
|
| 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 | Rate of Protocol-defined Exacerbations (PDE) From Baseline Through Week 24 | PDEs were characterized by a change or worsening from baseline of 1 or more documented signs or symptoms (decreased exercise tolerance, increased cough, increased sputum or chest congestion, decreased appetite, or other signs or symptoms) associated with the use of non-study IV or inhaled antibiotics and be verified by a blinded independent adjudication committee. | Intent-to-Treat (ITT) Analysis Set: all randomized participants | Posted | Number | PDEs per participant year | Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Actual Change From Baseline in FEV1 % Predicted Across All Courses of AZLI/Placebo Treatment (Weeks 4, 12 and 20) | 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. The adjusted mean is from a mixed-effect model repeated measures (MMRM) analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction. | Participants in the ITT Analysis Set with available data were analyzed. | Posted | Mean | Standard Error | percentage of FEV1 % predicted | Comparative Phase: Baseline and Weeks 4, 12 and 20 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Used Non-study IV or Inhaled Antibiotics for PDEs | ITT Analysis Set | Posted | Number | percentage of participants | Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Protocol-defined Pulmonary Exacerbation | The time to first protocol-defined pulmonary exacerbation was calculated using the Kaplan-Meier method. | ITT Analysis Set | Posted | Median | 95% Confidence Interval | days | Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Hospitalizations for a Respiratory Event | The rate of hospitalizations for a respiratory event per participant year was calculated using negative binomial regression analysis. | ITT Analysis Set | Posted | Number | hospitalizations per participant year | Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Change From Baseline in the CFQ-R Respiratory Symptom Scale (RSS) Score Across All Courses of AZLI/Placebo Treatment (Weeks 4, 12 and 20) | Respiratory symptoms (eg, coughing, congestion, wheezing) were assessed with the Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS). The range of scores (units) was 0 to 100 with higher scores indicating fewer symptoms. The adjusted mean is from a mixed-effect model repeated measures (MMRM) analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction. | Participants in the ITT Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Comparative Phase: Baseline and Weeks 4, 12 and 20 |
|
TIS Run-In Treatment Group: up to 28 days (plus 30 days if not continuing to the comparative phase). Comparative phase: from first dose of AZLI or Placebo through 30 days after last dose (average 155.4 days).
Safety analysis set: participants who were enrolled and received at least 1 dose of study drug
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TIS Run-In Treatment Group | Enrolled participants received 28 days of TIS (300 mg 2 times daily) during the run-in phase. | 4 | 107 | 27 | 107 | ||
| EG001 | AZLI | Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days. | 21 | 42 | 38 | 42 | ||
| EG002 | Placebo | Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days. | 24 | 46 | 44 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiopulmonary failure | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Blindness unilateral | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Infective exacerbation of bronchiectasis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Postoperative respiratory failure | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Exercise tolerance decreased | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Forced expiratory volume decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Pulmonary function test decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Increased viscosity of bronchial secretion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Sputum increased | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.0) | 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 | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D001398 | Aztreonam |
| ID | Term |
|---|---|
| D008997 | Monobactams |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Pregnancy |
|
| Adverse event, serious fatal |
|
| Withdrew consent |
|
| Protocol-specified criteria for withdraw |
|
| 13 - 17 years |
|
| ≥ 18 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White |
|
| Other |
|
| Participants |
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|