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The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
CF patients often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by a bacteria called Pseudomonas aeruginosa (PA). Treatment with antibiotics can stop or slow down the growth of the bacteria. The antibiotics may be given by mouth, intravenously (IV), or by inhalation as a mist. The purpose of this study was to evaluate the safety and efficacy of AZLI, an investigational formulation of the antibiotic aztreonam and administered TID using the PARI eFlow® electronic nebulizer, in CF patients with PA.
In this study, participant eligibility was assessed at a screening visit 7 to 14 days prior to the baseline visit (Day 0). Those participants who continued to meet eligibility criteria at Day 0 were randomized and began a 28-day course of blinded study treatment (AZLI TID or placebo TID). Participants returned for clinic visits at Day 14, an end of treatment visit at Day 28, and a follow-up visit 14 days after the last dose of study drug (Day 42).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo three times a day (TID) | Placebo Comparator |
| |
| AZLI 75 mg three times a day (TID) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZLI 75 mg three times a day (TID) | Drug |
| ||
| Placebo three times a day (TID) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CFQ-R Respiratory Symptoms Scale (RSS) Score | The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R respiratory symptoms scale (RSS; range of scores: 0-100; higher scores indicate fewer symptoms). | Day 0 to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CFQ-R RSS Score | The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms). | Day 0 to Day 14 |
| Change in CFQ-R RSS Score |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Other Pathogens Present | Sputum samples were collected at all visits for quantitative and qualitative culture for Staphylococcus aureus, Burkholderia cepacia, Stenotrophomonas maltophilia, Achromobacter xylosoxidans. | Day 0 to Day 28 |
| Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL) |
Inclusion Criteria:
Documentation of CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
PA present in expectorated sputum or throat swab culture at Screening.
FEV1 between (and including) 25% and 75% predicted at Screening.
Negative pregnancy test at Screening.
Ability to perform reproducible pulmonary function tests.
Arterial oxygen saturation (SaO2) greater than or equal to 90% on room air at Screening.
Ability to provide written informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Montgomery, MD | Corus Pharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | United States | |||
| Pediatric Breathing Disorders Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19420195 | Derived | Retsch-Bogart GZ, Quittner AL, Gibson RL, Oermann CM, McCoy KS, Montgomery AB, Cooper PJ. Efficacy and safety of inhaled aztreonam lysine for airway pseudomonas in cystic fibrosis. Chest. 2009 May;135(5):1223-1232. doi: 10.1378/chest.08-1421. |
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Planned study size was 140 participants to be randomized in a 1:1 ratio to AZLI or placebo TID, with 166 actually randomized (83 AZLI, 83 placebo). However, two participants did not receive a dose of drug, and one participant randomized to receive AZLI received placebo in error. Thus, 80 participants received AZLI and 84 received placebo.
Phase 3, double-blind, multicenter, multinational, randomized, placebo-controlled trial evaluating AZLI in patients with CF and PA. Participants were enrolled at 53 sites total: 40 in United States, 5 in Canada, 7 in Australia, and 1 in New Zealand. Date of first enrollment was 10 Jun 2005, and date of last participant follow-up was 3 Apr 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo TID | Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer. |
| FG001 | 75 mg AZLI TID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms). |
| Day 0 to Day 42 |
| Percent Change in FEV1 (L) | Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. The percent change from baseline in forced expiratory volume (liters) in one second (FEV1) was determined at Day 28. | Day 0 to Day 28 |
| Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum | Sputum samples were collected at all participant visits of the study for analysis of microbiology endpoints. Sputum samples were processed for qualitative and quantitative culture of PA (each morphotype). Due to the skewness of the distribution of CFU data, the data were transformed using the base 10 logarithm, in an attempt to normalize the data and allow for parametric tests, before calculating changes. To account for zero values, 1 was added to each CFU measurement before being transformed. Any CFU data values where PA was not isolated from a valid culture were set to zero. | Day 0 to Day 28 |
| Number of Participants Receiving Intravenous (IV) or Inhaled Antipseudomonal Antibiotics Other Than Trial Drug | Use of IV and inhaled antipseudomonal antibiotics was compiled from data recorded on the Concomitant Medications eCRF. | Day 0 to Day 42 |
| Number of Participants Hospitalized at Least Once Between Day 0 and Day 42 | Details of all hospitalizations, including the dates of admission and discharge, were recorded on the SAE eCRF. | Day 0 to Day 42 |
PA isolates from sputum samples (collected at all visits) were assessed for their susceptibility to aztreonam. MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism). MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism). MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis. |
| Day 0 |
| Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL) | PA isolates from sputum samples (collected at all visits) were assessed for their susceptibility to aztreonam. MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism). MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism). MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis. | Day 28 |
| Anchorage |
| Alaska |
| United States |
| Phoenix Children's Hospital | Phoenix | Arizona | United States |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States |
| Miller Children's Hospital | Long Beach | California | United States |
| Children's Hospital, Los Angeles | Los Angeles | California | United States |
| Children's Hospital of Orange County | Orange | California | United States |
| Capital Allergy and Respiratory Disease Center | Sacramento | California | United States |
| Yale New Haven Hospital | New Haven | Connecticut | United States |
| University of Florida Health Sciences Center | Gainesville | Florida | United States |
| Nemours Children's Clinic, Orlando | Orlando | Florida | United States |
| Medical College of Georgia | Augusta | Georgia | United States |
| Children's Memorial Hospital / Northwestern University | Chicago | Illinois | United States |
| Riley Hospital for Children | Indianapolis | Indiana | United States |
| University of Iowa | Iowa City | Iowa | United States |
| Via Christi - St. Francis Regional Medical Center | Wichita | Kansas | United States |
| Tulane University Health Sciences Center | New Orleans | Louisiana | United States |
| Louisiana State University Health Sciences Center | Shreveport | Louisiana | United States |
| Central Maine Pulmonary Associates | Auburn | Maine | United States |
| University of Michigan | Ann Arbor | Michigan | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | United States |
| University of Missouri | Columbia | Missouri | United States |
| St. Louis University | St Louis | Missouri | United States |
| Children's Lung Specialists | Las Vegas | Nevada | United States |
| St. Barnabas Healthcare System | Livingston | New Jersey | United States |
| Albany Medical College | Albany | New York | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | United States |
| SUNY Upstate Medical University | Syracuse | New York | United States |
| University of North Carolina | Chapel Hill | North Carolina | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | United States |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | United States |
| Pediatric Pulmonary Associates, South Carolina | Columbia | South Carolina | United States |
| Baylor Martha Foster Lung Care Center | Dallas | Texas | United States |
| Alamo Clinical Research Associates | San Antonio | Texas | United States |
| University of Utah | Salt Lake City | Utah | United States |
| Naval Medical Center | Portsmouth | Virginia | United States |
| Pediatric Pulmonary Center/Virginia Commonwealth University | Richmond | Virginia | United States |
| University of Washington Medical Center | Seattle | Washington | United States |
| University of Wisconsin | Madison | Wisconsin | United States |
| Children's Hospital at Westmead | Westmead | New South Wales | Australia |
| Westmead Hospital | Westmead | New South Wales | Australia |
| Royal Children's Hospital | Herston | Queensland | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | Australia |
| Alfred Hospital | Prahran | Victoria | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | Australia |
| Princess Margaret Hospital for Children | Perth | Western Australia | Australia |
| Capital Health and the Governors of the University of Alberta | Edmonton | Alberta | Canada |
| St. Paul's Hospital | Vancouver | British Columbia | Canada |
| Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | Canada |
| Brian Lyttle Professional Corporation | London | Ontario | Canada |
| Centre Hospitalier de l'Universite de Montreal (CHUM) | Montreal | Quebec | Canada |
| Auckland District Health Board | Auckland | New Zealand |
AZLI (75 mg/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 using the investigational nebulizer. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo TID | Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer. |
| BG001 | 75 mg AZLI TID | AZLI (75 mg/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 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Disease severity based on forced expiratory volume in 1 second (FEV1) % predicted | 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 subjects with FEV1 greater than 50% and less than or equal to 50% of the predicted value based on age, gender, and height at screening. | Number | participants |
|
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change in CFQ-R RSS Score | The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms). | ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used. | Posted | Mar 2010 | Least Squares Mean | Standard Error | units on a scale | Day 0 to Day 14 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in CFQ-R RSS Score | The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms). | ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used. | Posted | Mar 2010 | Least Squares Mean | Standard Error | units on a scale | Day 0 to Day 42 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Other Pathogens Present | Sputum samples were collected at all visits for quantitative and qualitative culture for Staphylococcus aureus, Burkholderia cepacia, Stenotrophomonas maltophilia, Achromobacter xylosoxidans. | Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis. | Posted | Mar 2010 | Number | participants | Day 0 to Day 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL) | PA isolates from sputum samples (collected at all visits) were assessed for their susceptibility to aztreonam. MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism). MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism). MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis. | Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis. | Posted | Mar 2010 | Number | μg/mL | Day 0 | PA isolates | Participants |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in FEV1 (L) | Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. The percent change from baseline in forced expiratory volume (liters) in one second (FEV1) was determined at Day 28. | ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used. | Posted | Mar 2010 | Least Squares Mean | Standard Error | Percent change in FEV1 (L) | Day 0 to Day 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum | Sputum samples were collected at all participant visits of the study for analysis of microbiology endpoints. Sputum samples were processed for qualitative and quantitative culture of PA (each morphotype). Due to the skewness of the distribution of CFU data, the data were transformed using the base 10 logarithm, in an attempt to normalize the data and allow for parametric tests, before calculating changes. To account for zero values, 1 was added to each CFU measurement before being transformed. Any CFU data values where PA was not isolated from a valid culture were set to zero. | Analysis based on ITT population (all participants randomized to treatment who received at least part of 1 dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis. | Posted | Mar 2010 | Least Squares Mean | Standard Error | Log10 PA CFUs/gram of sputum | Day 0 to Day 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Receiving Intravenous (IV) or Inhaled Antipseudomonal Antibiotics Other Than Trial Drug | Use of IV and inhaled antipseudomonal antibiotics was compiled from data recorded on the Concomitant Medications eCRF. | Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. | Posted | Mar 2010 | Number | participants | Day 0 to Day 42 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change in CFQ-R Respiratory Symptoms Scale (RSS) Score | The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R respiratory symptoms scale (RSS; range of scores: 0-100; higher scores indicate fewer symptoms). | ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used. | Posted | Mar 2010 | Least Squares Mean | Standard Error | units on a scale | Day 0 to Day 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Hospitalized at Least Once Between Day 0 and Day 42 | Details of all hospitalizations, including the dates of admission and discharge, were recorded on the SAE eCRF. | Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis. | Posted | Mar 2010 | Number | participants | Day 0 to Day 42 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL) | PA isolates from sputum samples (collected at all visits) were assessed for their susceptibility to aztreonam. MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism). MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism). MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis. | Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis. | Posted | Mar 2010 | Number | μg/mL | Day 28 | PA isolates | Participants |
|
AEs that first occurred or worsened after the first dose of study drug through 30 days after the last dose are summarized.
An AE was any physical or clinical worsening in symptoms or disease (including clinically significant change in lab values) experienced by participant at any time during the study, whether or not the event was considered related to study participation or study procedures.
Participants were only counted once within an SOC and preferred term.
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 | Placebo TID | Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer. | 12 | 84 | 67 | 84 | ||
| EG001 | 75 mg AZLI TID | AZLI (75 mg/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 using the investigational nebulizer. | 5 | 80 | 63 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA 8.0 |
| ||
| Blood glucose increased | Investigations | MedDRA 8.0 |
| ||
| Breath sounds decreased | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| C-reactive protein increased | Investigations | MedDRA 8.0 |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Crackles lung | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 8.0 |
| ||
| Dehydration | Metabolism and nutrition disorders | MedDRA 8.0 |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Dyspnoea exacerbated | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 8.0 |
| ||
| Exercise tolerance decreased | General disorders | MedDRA 8.0 |
| ||
| Fatigue | General disorders | MedDRA 8.0 |
| ||
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 8.0 |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Intercostal retraction | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 8.0 |
| ||
| Malnutrition | Metabolism and nutrition disorders | MedDRA 8.0 |
| ||
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 8.0 |
| ||
| Nausea | Gastrointestinal disorders | MedDRA 8.0 |
| ||
| Non-cardiac chest pain | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Oedema peripheral | General disorders | MedDRA 8.0 |
| ||
| Oxygen saturation decreased | Investigations | MedDRA 8.0 |
| ||
| Pain | General disorders | MedDRA 8.0 |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 8.0 |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Pulmonary function test decreased | Investigations | MedDRA 8.0 |
| ||
| Pyrexia | General disorders | MedDRA 8.0 |
| ||
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 8.0 |
| ||
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Thrombosis | Vascular disorders | MedDRA 8.0 |
| ||
| Umbilical hernia | Gastrointestinal disorders | MedDRA 8.0 |
| ||
| Weight decreased | Investigations | MedDRA 8.0 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 8.0 |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 8.0 |
| ||
| Chest discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Crackles lung | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Dyspnoea exacerbated | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Fatigue | General disorders | MedDRA 8.0 |
| ||
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Headache | Nervous system disorders | MedDRA 8.0 |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Pulmonary function test decreased | Investigations | MedDRA 8.0 |
| ||
| Pyrexia | General disorders | MedDRA 8.0 |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 |
|
Institution and investigator may publish or present the results of the trial generated there with prior written consent of Gilead; or 2 years after the trial has ended at all institutions. Proposed publications/target venue must go to Gilead 30 days (manuscripts) or 15 days (abstracts/presentations) prior. Any Gilead confidential information in the document(s) must be deleted, or if requested publication delayed for up to 45 days to permit Gilead to obtain intellectual property protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Bresnik, MD, Director, Clinical Research | Gilead Sciences, Inc. | (650) 522-5934 | mark.bresnik@gilead.com |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D011552 | Pseudomonas 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
| >=65 years |
|
| Male |
|
| Australia |
|
| Disease severity: FEV1 <= 50% predicted |
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