Trial Outcomes & Findings for OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis (NCT NCT02054156)
NCT ID: NCT02054156
Last Updated: 2019-10-01
Results Overview
Time to a protocol-defined pulmonary exacerbation requiring oral, inhaled, or intravenous antibiotics, using a prespecified definition available in the study protocol.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
221 participants
Primary outcome timeframe
Over the 18-month study period
Results posted on
2019-10-01
Participant Flow
Participant milestones
| Measure |
Azithromycin
azithromycin and tobramycin solution for inhalation (TIS) Azithromycin 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
azithromycin: 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months
Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
|
Placebo
placebo and tobramycin solution for inhalation (TIS) Placebo 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
placebo: 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months
Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
|
|---|---|---|
|
Overall Study
STARTED
|
110
|
111
|
|
Overall Study
COMPLETED
|
35
|
30
|
|
Overall Study
NOT COMPLETED
|
75
|
81
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis
Baseline characteristics by cohort
| Measure |
Azithromycin
n=110 Participants
azithromycin and tobramycin solution for inhalation (TIS) Azithromycin 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
azithromycin: 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months
Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
|
Placebo
n=111 Participants
placebo and tobramycin solution for inhalation (TIS) Placebo 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
placebo: 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months
Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
|
Total
n=221 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.1 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
6.8 years
STANDARD_DEVIATION 5.0 • n=7 Participants
|
6.9 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
|
Age, Customized
Age Distribution · >= 6 months - 3 years
|
39 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Age, Customized
Age Distribution · > 3 years - 6 years
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Customized
Age Distribution · > 6 years - 12 years
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Age, Customized
Age Distribution · > 12 years
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
100 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic or Latino
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African-American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian or Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown/Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
110 participants
n=5 Participants
|
111 participants
n=7 Participants
|
221 participants
n=5 Participants
|
|
Cystic Fibrosis (CF) Genotype
F508 del Homozygous
|
59 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Cystic Fibrosis (CF) Genotype
F508 del Heterozygous
|
35 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Cystic Fibrosis (CF) Genotype
Other
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Cystic Fibrosis (CF) Genotype
Unidentified
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Cystic Fibrosis (CF) Genotype
Not Available
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Over the 18-month study periodTime to a protocol-defined pulmonary exacerbation requiring oral, inhaled, or intravenous antibiotics, using a prespecified definition available in the study protocol.
Outcome measures
| Measure |
Azithromycin
n=110 Participants
azithromycin and tobramycin solution for inhalation (TIS) Azithromycin 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
azithromycin: 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months
Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
|
Placebo
n=111 Participants
placebo and tobramycin solution for inhalation (TIS) Placebo 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
placebo: 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months
Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
|
|---|---|---|
|
Time to a Protocol-defined Pulmonary Exacerbation
|
1.350 years
Interval 0.898 to
Too few events occurred to estimate the upper confidence bound
|
0.758 years
Interval 0.572 to 0.969
|
SECONDARY outcome
Timeframe: Over the 18-month study periodTime to Pseudomonas aeruginosa (Pa) recurrence after the first quarter of treatment
Outcome measures
| Measure |
Azithromycin
n=103 Participants
azithromycin and tobramycin solution for inhalation (TIS) Azithromycin 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
azithromycin: 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months
Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
|
Placebo
n=97 Participants
placebo and tobramycin solution for inhalation (TIS) Placebo 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
placebo: 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months
Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
|
|---|---|---|
|
Time to Pseudomonas Aeruginosa (Pa) Recurrence
|
1.51 years
Interval 0.76 to
Too few events occurred to estimate the upper confidence bound
|
1.46 years
Interval 0.78 to
Too few events occurred to estimate the upper confidence bound
|
SECONDARY outcome
Timeframe: Over the 18-month study periodThe number and percentage of participants with at least one event over the 18-month study period.
Outcome measures
| Measure |
Azithromycin
n=110 Participants
azithromycin and tobramycin solution for inhalation (TIS) Azithromycin 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
azithromycin: 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months
Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
|
Placebo
n=111 Participants
placebo and tobramycin solution for inhalation (TIS) Placebo 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
placebo: 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months
Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
|
|---|---|---|
|
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Participants with AE
|
102 Participants
|
98 Participants
|
|
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Participants with SAE
|
25 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Over the 18-month study periodRate is defined as the number of events per participant follow-up month.
Outcome measures
| Measure |
Azithromycin
n=110 Participants
azithromycin and tobramycin solution for inhalation (TIS) Azithromycin 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
azithromycin: 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months
Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
|
Placebo
n=111 Participants
placebo and tobramycin solution for inhalation (TIS) Placebo 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
placebo: 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months
Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
|
|---|---|---|
|
Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of AEs per participant month
|
0.92 events per participant-month
|
1.06 events per participant-month
|
|
Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of SAEs per participant month
|
0.06 events per participant-month
|
0.05 events per participant-month
|
Adverse Events
Azithromycin
Serious events: 25 serious events
Other events: 99 other events
Deaths: 0 deaths
Placebo
Serious events: 28 serious events
Other events: 92 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Azithromycin
n=110 participants at risk
azithromycin and tobramycin solution for inhalation (TIS) Azithromycin 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
azithromycin: 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months
Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
|
Placebo
n=111 participants at risk
placebo and tobramycin solution for inhalation (TIS) Placebo 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
placebo: 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months
Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Gastrointestinal disorders
Constipation
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.90%
1/111 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Gastrointestinal disorders
Distal intestinal obstruction syndrome
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
2/110 • Number of events 2 • 18 months
|
0.00%
0/111 • 18 months
|
|
General disorders
Chest pain
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.90%
1/111 • Number of events 2 • 18 months
|
|
General disorders
Crepitations
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
General disorders
Decreased activity
|
0.00%
0/110 • 18 months
|
0.90%
1/111 • Number of events 1 • 18 months
|
|
General disorders
Exercise tolerance decreased
|
0.00%
0/110 • 18 months
|
0.90%
1/111 • Number of events 1 • 18 months
|
|
General disorders
Fatigue
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
General disorders
Pain
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
General disorders
Pyrexia
|
3.6%
4/110 • Number of events 4 • 18 months
|
0.00%
0/111 • 18 months
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/110 • 18 months
|
0.90%
1/111 • Number of events 1 • 18 months
|
|
Infections and infestations
Appendicitis
|
0.00%
0/110 • 18 months
|
0.90%
1/111 • Number of events 1 • 18 months
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/110 • 18 months
|
0.90%
1/111 • Number of events 1 • 18 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/110 • 18 months
|
0.90%
1/111 • Number of events 1 • 18 months
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Infections and infestations
Pseudomonas infection
|
2.7%
3/110 • Number of events 3 • 18 months
|
1.8%
2/111 • Number of events 3 • 18 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Investigations
Breath sounds abnormal
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Investigations
Electrocardiogram QT prolonged
|
1.8%
2/110 • Number of events 2 • 18 months
|
6.3%
7/111 • Number of events 8 • 18 months
|
|
Investigations
Forced expiratory volume decreased
|
0.91%
1/110 • Number of events 2 • 18 months
|
0.90%
1/111 • Number of events 1 • 18 months
|
|
Investigations
Fungal test positive
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Investigations
Neutrophil count decreased
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Investigations
Oxygen saturation decreased
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Investigations
Pseudomonas test positive
|
1.8%
2/110 • Number of events 2 • 18 months
|
0.00%
0/111 • 18 months
|
|
Investigations
Pulmonary function test decreased
|
5.5%
6/110 • Number of events 7 • 18 months
|
5.4%
6/111 • Number of events 6 • 18 months
|
|
Investigations
Respiratory syncytial virus test positive
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Investigations
Sputum abnormal
|
0.00%
0/110 • 18 months
|
0.90%
1/111 • Number of events 1 • 18 months
|
|
Investigations
White blood cell count decreased
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/110 • 18 months
|
0.90%
1/111 • Number of events 1 • 18 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Nervous system disorders
Headache
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Nervous system disorders
Sinus headache
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Renal and urinary disorders
Dysuria
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/110 • 18 months
|
0.90%
1/111 • Number of events 1 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/110 • 18 months
|
0.90%
1/111 • Number of events 1 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.90%
1/111 • Number of events 1 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.3%
8/110 • Number of events 11 • 18 months
|
10.8%
12/111 • Number of events 13 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.7%
3/110 • Number of events 4 • 18 months
|
1.8%
2/111 • Number of events 2 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/110 • 18 months
|
0.90%
1/111 • Number of events 1 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/110 • 18 months
|
0.90%
1/111 • Number of events 1 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/110 • 18 months
|
0.90%
1/111 • Number of events 1 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.91%
1/110 • Number of events 1 • 18 months
|
0.00%
0/111 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.91%
1/110 • Number of events 1 • 18 months
|
1.8%
2/111 • Number of events 2 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.8%
2/110 • Number of events 2 • 18 months
|
2.7%
3/111 • Number of events 3 • 18 months
|
Other adverse events
| Measure |
Azithromycin
n=110 participants at risk
azithromycin and tobramycin solution for inhalation (TIS) Azithromycin 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
azithromycin: 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months
Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
|
Placebo
n=111 participants at risk
placebo and tobramycin solution for inhalation (TIS) Placebo 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
placebo: 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months
Tobramycin solution for inhalation: 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
|
|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
6.4%
7/110 • Number of events 7 • 18 months
|
5.4%
6/111 • Number of events 8 • 18 months
|
|
Gastrointestinal disorders
Abdominal pain
|
14.5%
16/110 • Number of events 19 • 18 months
|
16.2%
18/111 • Number of events 21 • 18 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.4%
7/110 • Number of events 8 • 18 months
|
11.7%
13/111 • Number of events 23 • 18 months
|
|
Gastrointestinal disorders
Constipation
|
8.2%
9/110 • Number of events 13 • 18 months
|
11.7%
13/111 • Number of events 13 • 18 months
|
|
Gastrointestinal disorders
Diarrhoea
|
14.5%
16/110 • Number of events 28 • 18 months
|
12.6%
14/111 • Number of events 27 • 18 months
|
|
Gastrointestinal disorders
Nausea
|
3.6%
4/110 • Number of events 8 • 18 months
|
8.1%
9/111 • Number of events 9 • 18 months
|
|
Gastrointestinal disorders
Teething
|
6.4%
7/110 • Number of events 7 • 18 months
|
2.7%
3/111 • Number of events 5 • 18 months
|
|
Gastrointestinal disorders
Vomiting
|
24.5%
27/110 • Number of events 43 • 18 months
|
13.5%
15/111 • Number of events 19 • 18 months
|
|
General disorders
Fatigue
|
10.0%
11/110 • Number of events 14 • 18 months
|
6.3%
7/111 • Number of events 8 • 18 months
|
|
General disorders
Pyrexia
|
43.6%
48/110 • Number of events 94 • 18 months
|
31.5%
35/111 • Number of events 79 • 18 months
|
|
Infections and infestations
Ear infection
|
6.4%
7/110 • Number of events 13 • 18 months
|
4.5%
5/111 • Number of events 7 • 18 months
|
|
Infections and infestations
Otitis media
|
11.8%
13/110 • Number of events 19 • 18 months
|
7.2%
8/111 • Number of events 10 • 18 months
|
|
Infections and infestations
Pharyngitis streptococcal
|
3.6%
4/110 • Number of events 5 • 18 months
|
10.8%
12/111 • Number of events 19 • 18 months
|
|
Infections and infestations
Sinusitis
|
6.4%
7/110 • Number of events 10 • 18 months
|
6.3%
7/111 • Number of events 8 • 18 months
|
|
Infections and infestations
Upper respiratory tract infection
|
12.7%
14/110 • Number of events 20 • 18 months
|
13.5%
15/111 • Number of events 18 • 18 months
|
|
Investigations
Pulmonary function test decreased
|
5.5%
6/110 • Number of events 9 • 18 months
|
9.9%
11/111 • Number of events 13 • 18 months
|
|
Investigations
Weight decreased
|
2.7%
3/110 • Number of events 3 • 18 months
|
5.4%
6/111 • Number of events 6 • 18 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
11/110 • Number of events 20 • 18 months
|
14.4%
16/111 • Number of events 20 • 18 months
|
|
Nervous system disorders
Headache
|
20.9%
23/110 • Number of events 35 • 18 months
|
17.1%
19/111 • Number of events 44 • 18 months
|
|
Nervous system disorders
Lethargy
|
1.8%
2/110 • Number of events 2 • 18 months
|
5.4%
6/111 • Number of events 8 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
63.6%
70/110 • Number of events 185 • 18 months
|
66.7%
74/111 • Number of events 220 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.4%
7/110 • Number of events 10 • 18 months
|
1.8%
2/111 • Number of events 3 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.2%
9/110 • Number of events 10 • 18 months
|
9.0%
10/111 • Number of events 11 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.3%
8/110 • Number of events 8 • 18 months
|
5.4%
6/111 • Number of events 41 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
32.7%
36/110 • Number of events 54 • 18 months
|
28.8%
32/111 • Number of events 71 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
19.1%
21/110 • Number of events 26 • 18 months
|
13.5%
15/111 • Number of events 38 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.2%
9/110 • Number of events 11 • 18 months
|
4.5%
5/111 • Number of events 7 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
7.3%
8/110 • Number of events 18 • 18 months
|
14.4%
16/111 • Number of events 23 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
30.9%
34/110 • Number of events 81 • 18 months
|
32.4%
36/111 • Number of events 90 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
6.4%
7/110 • Number of events 9 • 18 months
|
5.4%
6/111 • Number of events 12 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
15.5%
17/110 • Number of events 26 • 18 months
|
13.5%
15/111 • Number of events 21 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
14.5%
16/110 • Number of events 22 • 18 months
|
11.7%
13/111 • Number of events 20 • 18 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.4%
7/110 • Number of events 8 • 18 months
|
7.2%
8/111 • Number of events 11 • 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place