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The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
Patients with CF often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by a bacteria called 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 aztreonam for inhalation solution (AZLI), an investigational formulation of the antibiotic administered using the eFlow® Electronic Nebulizer by PARI GmbH, in CF patients with PA.
In this study, participants were screened for eligibility at Visit 1 (Day -42) and returned to the center for Visit 2 after a 14-day evaluation period. At Visit 2 (Day -28), participants began a 28-day course of open-label Tobramycin Inhalation Solution (TIS). At Visit 3 (Day 0), following completion of the 28-day course of TIS, participants began randomized, blinded treatment with either AZLI twice a day (BID) or three times a day (TID) or placebo BID or TID, and continued treatment for a total of 28 days, with a clinic visit at Day 14 (Visit 4) and at the end of treatment (Visit 5 [Day 28]). Participants returned for visits every 2 weeks for 8 weeks after the end of the blinded treatment (Visits 6 to 9 [Days 42 to 84]).
Two hundred and forty-seven participants were treated in the TIS phase of this study. Two hundred and eleven subjects completed the TIS phase and were treated in the placebo-controlled phase with study drug (AZLI or placebo).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (pooled two times a day [BID]/three times a day [TID]) | Placebo Comparator |
| |
| AZLI (pooled two times a day [BID]/three times a day [TID]) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZLI 75 mg two times a day (BID)/three times a day (TID) | Drug |
| ||
| Placebo two times a day (BID)/three times a day (TID) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics | The primary endpoint was time to need for a course of inhaled or IV antipseudomonal antibiotics with documented physician assessment of need for antibiotics. Antipseudomonal Antibiotic need was documented based on the presence of at least one of the following four symptoms predictive of pulmonary exacerbation: decreased exercise tolerance, increased cough, increased sputum / chest congestion, decreased appetite, or other. | Day 0 to Day 84 (end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score | The CFQ-R was administered at Day -28, baseline, Day 14, Day 28, and Day 84 (end of study). The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores [units]: 0-100; higher scores indicate fewer symptoms). | Day 0 to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Other Pathogens | Sputum samples were collected at all visits for quantitative and qualitative culture for Staphylococcus aureus, Burkholderia cepacia, Stenotrophomonas maltophilia, and Achromobacter xylosoxidans. Number of participants with other pathogens at baseline and at the end of treatment (28 days) are reported. | Day 0 and Day 28 |
Inclusion Criteria:
CF as diagnosed by:
PA present in expectorated sputum or throat swab culture at Screening.
Participants must have received three or more courses of TIS within the previous 12 months.
Participants on chronic azithromycin must have had no change in regimen in the previous 3 months and must have had a need for TIS and/or additional antipseudomonal therapy since initiation of azithromycin.
Forced expiratory volume in 1 second (FEV1) between (and including) 25% and 75% predicted at Screening.
Ability to perform reproducible pulmonary function tests.
Arterial oxygen saturation (SaO2) greater than or equal to 90% on room air at Screening.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen McCoy, MD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | United States | |||
| University of Arkansas for Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19447923 | Derived | Quittner AL, Modi AC, Wainwright C, Otto K, Kirihara J, Montgomery AB. Determination of the minimal clinically important difference scores for the Cystic Fibrosis Questionnaire-Revised respiratory symptom scale in two populations of patients with cystic fibrosis and chronic Pseudomonas aeruginosa airway infection. Chest. 2009 Jun;135(6):1610-1618. doi: 10.1378/chest.08-1190. Epub 2009 May 15. | |
| 18658109 |
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Subjects were randomized in 1:1:2:2 ratio to placebo twice a day (BID) or three times a day (TID) and AZLI BID or TID, respectively. A total of 211 subjects were included in the ITT analyses: 38 placebo BID, 38 placebo TID, 69 AZLI BID, and 66 AZLI TID. All analyses were conducted on pooled placebo (n = 76) versus pooled AZLI (n = 135) groups.
Participants were enrolled at 56 sites in the United States. Date of first enrollment was 24 February 2005, and date of last participant follow-up was 07 September 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (Pooled BID/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 twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| Percent Change in Forced Expiratory Volume in 1 Second (FEV1) (L) | Spirometry was performed at each visit. FEV1 was recorded according to American Thoracic Society (ATS) guidelines. FEV1(L) is the measurement of the volume of air (expressed in liters) exhaled in 1 second. The percent change in this parameter from Day 0 to Day 28 was determined for each treatment group. | Day 0 to Day 28 |
| Number of Hospitalization Days | Details of all hospitalizations, including the dates of admission and discharge, were recorded on the electronic case report form (eCRF). | Day 0 to Day 84 |
| 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 |
| Minimum Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL) | The aztreonam susceptibility of PA isolates from sputum samples (collected at all visits) was assessed. 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 to Day 28 |
| Little Rock |
| Arkansas |
| United States |
| University of California, San Diego | La Jolla | California | United States |
| Children's Hospital Los Angeles | Los Angeles | California | United States |
| Kaiser Permanente Medical Care Program | Oakland | California | United States |
| Children's Hospital, Orange Co. | Orange | California | United States |
| Stanford University Hospital and Medical Center | Palo Alto | California | United States |
| UC Davis Medical Center | Sacramento | California | United States |
| Children's Hospital | Denver | Colorado | United States |
| Connecticut Children's Medical Center | Hartford | Connecticut | United States |
| University of Florida Health Sciences Center | Gainesville | Florida | United States |
| Nemours Children's Clinic, Jacksonville | Jacksonville | Florida | United States |
| University of Miami School of Medicine | Miami | Florida | United States |
| Nemours Children's Clinic | Orlando | Florida | United States |
| Pediatric Pulmonary Associates, Florida | St. Petersburg | Florida | United States |
| Emory Healthcare | Atlanta | Georgia | United States |
| Medical College of Georgia | Augusta | Georgia | United States |
| Children's Memorial Hospital/Northwestern University | Chicago | Illinois | United States |
| Chicago Children's Asthma Respiratory and Exercise Specialists | Glenview | Illinois | United States |
| Loyola University Medical Center | Maywood | Illinois | United States |
| North Suburban Pulmonary / Critical Care Consultants | Niles | Illinois | United States |
| Indiana University | Indianapolis | Indiana | United States |
| University of Kansas Medical Center | Kansas City | Kansas | United States |
| Maine Medical Center | Portland | Maine | United States |
| Children's Hospital, Boston | Boston | Massachusetts | United States |
| Floating Hospital for Children | Boston | Massachusetts | United States |
| Massachusetts General Hospital | Boston | Massachusetts | United States |
| University of Michigan | Ann Arbor | Michigan | United States |
| Children's Hospital of Michigan/Wayne State University | Detroit | Michigan | United States |
| University of Minnesota | Minneapolis | Minnesota | United States |
| Children's Lung Specialists, Ltd. | Las Vegas | Nevada | United States |
| Morristown Memorial Hospital | Morristown | New Jersey | United States |
| Albany Medical College | Albany | New York | United States |
| Long Island College Hospital | Brooklyn | New York | United States |
| Children's Hospital of Buffalo | Buffalo | New York | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | United States |
| Columbia University Medical Center | New York | New York | United States |
| State University of New York Stony Brook | Stony Brook | New York | United States |
| Children's Hospital of Westchester Medical Center/New York Medical College | Valhalla | New York | United States |
| Akron Children's Hospital | Akron | Ohio | United States |
| Columbus Children's Hospital, Ohio State University | Columbus | Ohio | United States |
| Children's Medical Center | Dayton | Ohio | United States |
| Dr. Santiago Reyes | Oklahoma City | Oklahoma | United States |
| Oregon Health & Science University | Portland | Oregon | United States |
| Penn State University Hershey Medical Center | Hershey | Pennsylvania | United States |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | United States |
| St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | United States |
| Children's Hospital of Pittsburg | Pittsburgh | Pennsylvania | United States |
| Rhode Island Hospital | Providence | Rhode Island | United States |
| Medical University of South Carolina | Charleston | South Carolina | United States |
| Pediatric Pulmonary Associates, South Carolina | Columbia | South Carolina | United States |
| Baylor College of Medicine | Houston | Texas | United States |
| Alamo Clinical Research Associates | San Antonio | Texas | United States |
| Pediatric Pulmonary Center | Richmond | Virginia | United States |
| Children's Hospital and Regional Medical Center | Seattle | Washington | United States |
| West Virginia University | Morgantown | West Virginia | United States |
| Derived |
| McCoy KS, Quittner AL, Oermann CM, Gibson RL, Retsch-Bogart GZ, Montgomery AB. Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. Am J Respir Crit Care Med. 2008 Nov 1;178(9):921-8. doi: 10.1164/rccm.200712-1804OC. Epub 2008 Jul 24. |
| FG001 |
| AZLI (Pooled BID/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 BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (Pooled BID/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 twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups. |
| BG001 | AZLI (Pooled BID/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 BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups. |
| 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 |
|
| 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 | Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics | The primary endpoint was time to need for a course of inhaled or IV antipseudomonal antibiotics with documented physician assessment of need for antibiotics. Antipseudomonal Antibiotic need was documented based on the presence of at least one of the following four symptoms predictive of pulmonary exacerbation: decreased exercise tolerance, increased cough, increased sputum / chest congestion, decreased appetite, or other. | Analysis based on intents to treat (ITT) population (all participants randomized to treatment who received at least part of one dose of study drug). | Posted | Mar 2010 | Median | 95% Confidence Interval | Days | Day 0 to Day 84 (end of study) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score | The CFQ-R was administered at Day -28, baseline, Day 14, Day 28, and Day 84 (end of study). The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores [units]: 0-100; higher scores indicate fewer symptoms). | Analysis based on ITT population (all participants randomized to tx who received at least part of one dose of study drug). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to AE or study drug intolerance. For all other missing data, LOCF method was used. | Posted | Mar 2010 | Least Squares Mean | Standard Error | Units on a scale | Day 0 to Day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Forced Expiratory Volume in 1 Second (FEV1) (L) | Spirometry was performed at each visit. FEV1 was recorded according to American Thoracic Society (ATS) guidelines. FEV1(L) is the measurement of the volume of air (expressed in liters) exhaled in 1 second. The percent change in this parameter from Day 0 to Day 28 was determined for each treatment group. | Analysis based on ITT population (all participants who received at least part of one dose of study drug). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF imputation method was used. | Posted | Mar 2010 | Least Squares Mean | Standard Error | Percent change in FEV1 (L) | Day 0 to Day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Hospitalization Days | Details of all hospitalizations, including the dates of admission and discharge, were recorded on the electronic case report form (eCRF). | Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). No imputation methods were used for the analysis. | Posted | Mar 2010 | Mean | Standard Deviation | Days | Day 0 to Day 84 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 one dose of study drug). 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Other Pathogens | Sputum samples were collected at all visits for quantitative and qualitative culture for Staphylococcus aureus, Burkholderia cepacia, Stenotrophomonas maltophilia, and Achromobacter xylosoxidans. Number of participants with other pathogens at baseline and at the end of treatment (28 days) are reported. | Analysis based on ITT population (all participants who received at least part of one dose of study drug). No imputation methods were used for the analysis. | Posted | Mar 2010 | Number | Participants | Day 0 and Day 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Minimum Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL) | The aztreonam susceptibility of PA isolates from sputum samples (collected at all visits) was assessed. 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 who received at least part of one dose of study drug). No imputation methods were used for the analysis. | Posted | Mar 2010 | Number | μg/mL | Day 0 to Day 28 |
|
AEs that first occurred or worsened after the first dose of study drug through 30 days after the last dose (Day 0 to Day 56) 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 treatment period of study, whether or not event was considered related to study participation or procedures. Participants were only counted once within an SOC and preferred term.
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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 | Placebo (Pooled BID/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 twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups. | 3 | 76 | 65 | 76 | ||
| EG001 | AZLI (Pooled BID/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 BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups. | 13 | 135 | 121 | 135 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain lower | Gastrointestinal disorders | MedDra 8.0 |
| ||
| Chest X-ray abnormal | Investigations | 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 |
| ||
| Exercise tolerance decreased | General disorders | MedDra 8.0 |
| ||
| Fatigue | General disorders | MedDra 8.0 |
| ||
| Forced expiratory volume decreased | Investigations | MedDra 8.0 |
| ||
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDra 8.0 |
| ||
| Intestinal obstruction | Gastrointestinal disorders | MedDra 8.0 |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | MedDra 8.0 |
| ||
| Neurological symptoms | Nervous system disorders | MedDra 8.0 |
| ||
| Non-cardiac chest 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 |
| ||
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDra 8.0 |
| ||
| Spinal cord injury | Injury, poisoning and procedural complications | MedDra 8.0 |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDra 8.0 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDra 8.0 |
| ||
| Abdominal pain upper | Gastrointestinal disorders | MedDra 8.0 |
| ||
| Blood glucose increased | Investigations | 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 |
| ||
| Decreased appetite | Metabolism and nutrition disorders | MedDra 8.0 |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDra 8.0 |
| ||
| Dysphonia | 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 |
| ||
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDra 8.0 |
| ||
| Exercise tolerance decreased | General disorders | MedDra 8.0 |
| ||
| Fatigue | General disorders | MedDra 8.0 |
| ||
| Forced expiratory volume decreased | Respiratory, thoracic and mediastinal 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 |
| ||
| Nausea | Gastrointestinal 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 |
| ||
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDra 8.0 |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDra 8.0 |
| ||
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDra 8.0 |
| ||
| Sinus headache | Respiratory, thoracic and mediastinal disorders | MedDra 8.0 |
| ||
| Vomiting | Gastrointestinal disorders | MedDra 8.0 |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDra 8.0 |
|
The study was designed such that participants were discontinued from study participation upon meeting the primary endpoint (time to need for inhaled or IV antipseudomonal antibiotics).
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 |
|
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| Participants |
|
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|
|
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| Units | Counts |
|---|---|
| Participants |
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