Randomized, Controlled Study of CF Patients Between 3 Mon... | NCT01082367 | Trialant
NCT01082367
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Jul 15, 2016Estimated
Enrollment
50Actual
Phase
Phase 3
Conditions
Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients
Interventions
TOBI
Placebo
Countries
Canada
Egypt
France
Germany
Greece
Hungary
Italy
Romania
Russia
Switzerland
Protocol Section
Identification Module
NCT ID
NCT01082367
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CTBM100C2304
Secondary IDs
ID
Type
Description
Link
2009-016590-15
EudraCT Number
Brief Title
Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. Aeruginosa in Cystic Fibrosis Subjects Aged From 3 Months to Less Than 7 Years
Acronym
EARLY
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jun 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2010
Primary Completion Date
Jun 2015Actual
Completion Date
Jun 2015Actual
First Submitted Date
Mar 5, 2010
First Submission Date that Met QC Criteria
Mar 5, 2010
First Posted Date
Mar 8, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 22, 2015
Results First Submitted that Met QC Criteria
Mar 24, 2016
Results First Posted Date
Apr 27, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 6, 2016
Last Update Posted Date
Jul 15, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This study investigated the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.
Detailed Description
Not provided
Conditions Module
Conditions
Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients
Keywords
Tobramycin Inhalation solution
Cystic fibrosis
Lung disease
anti-bacterial agents
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
50Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
TOBI (tobramycin inhaled solution)/Placebo
Experimental
Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle).
Drug: TOBI
Drug: Placebo
Placebo/TOBI
Placebo Comparator
Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle).
Drug: TOBI
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
TOBI
Drug
TOBI (tobramycin inhaled solution)
Placebo/TOBI
TOBI (tobramycin inhaled solution)/Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle
Sputum/throat swab cultures were assessed.
Day 29
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Free From P. Aeruginosa 28 Days After Termination of the Second Treatment Cycle
Sputum/throat swab cultures were assessed.
Day 91
Percentage of Participants P Aeruginosa-free at Termination of the Double Blind Period
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of cystic fibrosis
Early lower respiratory tract infection with P. aeruginosa,
Exclusion Criteria:
Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
Administration of loop diuretics within 7 days prior to study drug administration.
Other protocol-defined inclusion/exclusion criteria may apply
Ratjen F, Moeller A, McKinney ML, Asherova I, Alon N, Maykut R, Angyalosi G; EARLY study group. Eradication of early P. aeruginosa infection in children <7 years of age with cystic fibrosis: The early study. J Cyst Fibros. 2019 Jan;18(1):78-85. doi: 10.1016/j.jcf.2018.04.002. Epub 2018 Apr 21.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
The cross-over was optional. At the end of the cross-over or OL phase, participants who were P.a positive terminated the study. P.a negative participants entered follow-up.
Recruitment Details
Participants were randomized 1:1 to TOBI or placebo. After 1 treatment cycle, participants who were P.a positive entered an OL phase. Participants who were P.a negative entered cross-over treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
TOBI (Tobramycin Inhaled Solution)/Placebo
Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
FG00026 subjects
FG00125 subjects
Stage 1:1st Treatment (tx) Cycle
FG00026 subjects
FG00125 subjects1 participant discontinued after cycle 1 due to an SAE
Stage 2:no tx
FG0000 subjects
FG0010 subjects
Entered OL TOBI
FG0004 subjects
FG00118 subjects
P.A-free,Day 29 w/ no Cross-over
FG0009 subjects
FG0010 subjects
Stage 3: Cross-over (co) tx
FG00013 subjects
FG0016 subjects
Stage 4:no tx for Patients Not in co
FG0000 subjects
FG0010 subjects
COMPLETED
FG00021 subjects
FG00112 subjects
NOT COMPLETED
FG0005 subjects
FG00113 subjects
Type
Comment
Reasons
Administrative problems
FG0000 subjects
FG0011 subjects
Lack of Efficacy
FG0005 subjects
FG00111 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
Follow-up (F-U) Period
Type
Comment
Milestone Data
STARTED
FG00019 subjects
FG00110 subjects
Treated in F-U
FG0005 subjects
FG0015 subjects
COMPLETED
FG00017 subjects
FG0019 subjects
NOT COMPLETED
FG0002 subjects
FG0011 subjects
Type
Comment
Reasons
Administrative problems
FG0001 subjects
FG0010 subjects
Abnormal lab values
FG0001 subjects
FG001
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
TOBI (Tobramycin Inhaled Solution)/Placebo
Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
BG001
Placebo/TOBI
Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00026
BG00125
BG00251
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG0002.9± 1.96
BG0012.7± 1.93
BG0022.8± 1.93
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00015
BG00117
BG002
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
Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle
Sputum/throat swab cultures were assessed.
Intent-to-treat (ITT): The ITT included all randomized participants who received at least dose of study treatment.
Posted
Number
Percentage of participants
Day 29
ID
Title
Description
OG000
TOBI (Tobramycin Inhaled Solution)/Placebo
Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
OG001
Placebo/TOBI
Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
Units
Counts
Participants
OG00026
OG00125
Title
Denominators
Categories
Title
Measurements
OG00084.6
OG00124.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
<0.001
Odds Ratio (OR)
21.55
2-Sided
95
4.67
99.52
No
Superiority or Other
Secondary
Percentage of Participants Free From P. Aeruginosa 28 Days After Termination of the Second Treatment Cycle
Sputum/throat swab cultures were assessed.
Cross-over participants from the ITT population were analyzed.
Posted
Number
Percentage of participants
Day 91
ID
Title
Description
OG000
TOBI (Tobramycin Inhaled Solution)/Placebo
Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
OG001
Placebo/TOBI
Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
Secondary
Percentage of Participants P Aeruginosa-free at Termination of the Double Blind Period
Sputum/throat swab cultures were assessed.
Participants from the ITT population, who were tested for microbiology, were included in the analysis.
Posted
Number
Percentage of participants
Day 91
ID
Title
Description
OG000
TOBI (Tobramycin Inhaled Solution)/Placebo
Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
OG001
Placebo/TOBI
Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
DB TOBI
DB TOBI
0
32
12
32
EG001
DB Placebo
DB Placebo
1
38
18
38
EG002
OL TOBI (Core)
OL TOBI (core)
0
22
10
22
EG003
Off-treatment (Core)
Off-treatment (core)
2
50
13
50
EG004
OL TOBI (Follow-up)
OL TOBI (follow-up)
0
10
2
10
EG005
Off-treatment (Follow-up)
Off-treatment (follow-up)
4
29
23
29
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG0030 affected50 at risk
EG0040 affected10 at risk
EG0051 affected29 at risk
Glucose-6-phosphate dehydrogenase deficiency
Congenital, familial and genetic disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Bacterial disease carrier
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Croup infectious
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Infective pulmonary exacerbation of cystic fibrosis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Laryngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Lower respiratory tract infection bacterial
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Pseudomonas infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Upper respiratory tract infection bacterial
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected38 at risk
EG0020 affected22 at risk
EG003
Stridor
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Hypertension
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Ear pain
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected38 at risk
EG0020 affected22 at risk
EG0030 affected50 at risk
EG0040 affected10 at risk
EG0050 affected29 at risk
Eye discharge
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected38 at risk
EG0020 affected22 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0021 affected22 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Faeces soft
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Oral mucosal eruption
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0021 affected22 at risk
EG003
Teething
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0013 affected38 at risk
EG0020 affected22 at risk
EG003
Asthenia
General disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Pyrexia
General disorders
MedDRA
Systematic Assessment
EG0002 affected32 at risk
EG0013 affected38 at risk
EG0022 affected22 at risk
EG003
Food allergy
Immune system disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Ear infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected38 at risk
EG0021 affected22 at risk
EG003
Eye infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected38 at risk
EG0020 affected22 at risk
EG003
Lobar pneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Lower respiratory tract infection bacterial
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0021 affected22 at risk
EG003
Lung infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected38 at risk
EG0021 affected22 at risk
EG003
Otitis media
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Perineal infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Pseudomonas infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected38 at risk
EG0021 affected22 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0013 affected38 at risk
EG0020 affected22 at risk
EG003
Rhinitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected38 at risk
EG0020 affected22 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0021 affected22 at risk
EG003
Varicella
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected38 at risk
EG0020 affected22 at risk
EG003
Foreign body
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Acinetobacter test positive
Investigations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0012 affected38 at risk
EG0020 affected22 at risk
EG003
Aspergillus test positive
Investigations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Pseudomonas test positive
Investigations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected38 at risk
EG0020 affected22 at risk
EG003
Streptococcus test positive
Investigations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0021 affected22 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected38 at risk
EG0020 affected22 at risk
EG003
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Lethargy
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0021 affected22 at risk
EG003
Bruxism
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Catarrh
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected38 at risk
EG0020 affected22 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0004 affected32 at risk
EG0016 affected38 at risk
EG0024 affected22 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Increased bronchial secretion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0021 affected22 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0021 affected22 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected38 at risk
EG0022 affected22 at risk
EG003
Snoring
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 affected32 at risk
EG0011 affected38 at risk
EG0020 affected22 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected38 at risk
EG0020 affected22 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Novartis
862-778-8300
ID
Term
D003550
Cystic Fibrosis
D008171
Lung Diseases
Ancestor Terms
ID
Term
D010182
Pancreatic Diseases
D004066
Digestive System Diseases
D012140
Respiratory Tract Diseases
D030342
Genetic Diseases, Inborn
D009358
Congenital, Hereditary, and Neonatal Diseases and Abnormalities