Trial Outcomes & Findings for Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis (NCT NCT00097773)
NCT ID: NCT00097773
Last Updated: 2014-02-28
Results Overview
The primary comparison is between the pooled culture-based group and the pooled cycled group. A secondary comparison is between the pooled ciprofloxacin group vs the pooled placebo group. Descriptive results are provided for the pooled treatment groups. Participants are represented once in the cycled and culture-based therapy columns, and once in the cipro and placebo columns.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
304 participants
Primary outcome timeframe
Measured over the 18 month study
Results posted on
2014-02-28
Participant Flow
Recruitment was conducted from December 2004 to June 2009 from 55 Cystic Fibrosis Foundation accredited clinical centers throughout the US
Participant milestones
| Measure |
Cycled TOBI and Oral Placebo
Tobramycin solution for inhalation (TOBI) and oral placebo for six consecutive quarterly cycles
|
Cycled TOBI and Oral Ciprofloxacin
Tobramycin solution for inhalation (TOBI) and oral ciprofloxacin for six consecutive quarterly cycles
|
Culture-Based TOBI and Oral Ciprofloxacin
Tobramycin solution for inhalation (TOBI) and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
|
Culture-Based TOBI and Oral Placebo
Tobramycin solution for inhalation (TOBI) and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
76
|
76
|
76
|
76
|
|
Overall Study
COMPLETED
|
68
|
68
|
68
|
73
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
8
|
3
|
Reasons for withdrawal
| Measure |
Cycled TOBI and Oral Placebo
Tobramycin solution for inhalation (TOBI) and oral placebo for six consecutive quarterly cycles
|
Cycled TOBI and Oral Ciprofloxacin
Tobramycin solution for inhalation (TOBI) and oral ciprofloxacin for six consecutive quarterly cycles
|
Culture-Based TOBI and Oral Ciprofloxacin
Tobramycin solution for inhalation (TOBI) and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
|
Culture-Based TOBI and Oral Placebo
Tobramycin solution for inhalation (TOBI) and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
0
|
1
|
|
Overall Study
Physician Decision
|
2
|
2
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
3
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
|
Overall Study
Other
|
1
|
0
|
2
|
0
|
Baseline Characteristics
Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis
Baseline characteristics by cohort
| Measure |
Cycled TIS w/Placebo
n=76 Participants
TOBI and oral placebo for six consecutive quarterly cycles
|
Cycled TIS w/Cipro
n=76 Participants
TOBI and oral ciprofloxacin for six consecutive quarterly cycles
|
Culture-Based TIS w/Placebo
n=76 Participants
TOBI and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
|
Culture-Based TIS w/Cipro
n=76 Participants
TOBI and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
76 Participants
n=93 Participants
|
76 Participants
n=4 Participants
|
76 Participants
n=27 Participants
|
76 Participants
n=483 Participants
|
304 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
5.8 years
STANDARD_DEVIATION 3.43 • n=93 Participants
|
5.9 years
STANDARD_DEVIATION 3.28 • n=4 Participants
|
6.0 years
STANDARD_DEVIATION 3.74 • n=27 Participants
|
5.0 years
STANDARD_DEVIATION 3.58 • n=483 Participants
|
5.7 years
STANDARD_DEVIATION 3.51 • n=36 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
37 Participants
n=483 Participants
|
154 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
39 Participants
n=483 Participants
|
150 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=93 Participants
|
76 participants
n=4 Participants
|
76 participants
n=27 Participants
|
76 participants
n=483 Participants
|
304 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Measured over the 18 month studyPopulation: Intent to treat
The primary comparison is between the pooled culture-based group and the pooled cycled group. A secondary comparison is between the pooled ciprofloxacin group vs the pooled placebo group. Descriptive results are provided for the pooled treatment groups. Participants are represented once in the cycled and culture-based therapy columns, and once in the cipro and placebo columns.
Outcome measures
| Measure |
Cycled TIS
n=152 Participants
Pooled Cycled tobramycin solution for inhalation (TIS) therapy group
|
Culture-Based TIS
n=152 Participants
Pooled Culture-Based TIS therapy group
|
Oral Ciprofloxacin
n=152 Participants
Pooled oral cipro group
|
Oral Placebo
n=152 Participants
Pooled oral placebo group
|
|---|---|---|---|---|
|
Number of Participants With a Pulmonary Exacerbation Requiring IV Antibiotics or Hospitalization
|
24 number of participants
|
26 number of participants
|
29 number of participants
|
21 number of participants
|
SECONDARY outcome
Timeframe: Week 10 (after initial treatment course for Pa) through Month 18Population: Intent to treat
Proportion of participants with a Pa positive culture compared between (1) the pooled cycled therapy group (n=152) and pooled culture-based therapy group (n=152), and (2) between the pooled oral placebo (n=152)and pooled cipro groups (n=152). Participants are included once in the cycled and culture-based columns, and once in the oral cipro and placebo columns
Outcome measures
| Measure |
Cycled TIS
n=152 Participants
Pooled Cycled tobramycin solution for inhalation (TIS) therapy group
|
Culture-Based TIS
n=152 Participants
Pooled Culture-Based TIS therapy group
|
Oral Ciprofloxacin
n=152 Participants
Pooled oral cipro group
|
Oral Placebo
n=152 Participants
Pooled oral placebo group
|
|---|---|---|---|---|
|
Proportion of Participants With a Pa Positive Culture
2 Pa positive cultures
|
9 Participants
|
18 Participants
|
13 Participants
|
14 Participants
|
|
Proportion of Participants With a Pa Positive Culture
No Pa positive cultures
|
109 Participants
|
85 Participants
|
97 Participants
|
97 Participants
|
|
Proportion of Participants With a Pa Positive Culture
1 Pa positive culture
|
17 Participants
|
38 Participants
|
22 Participants
|
33 Participants
|
|
Proportion of Participants With a Pa Positive Culture
3 or more Pa positive cultures
|
13 Participants
|
9 Participants
|
14 Participants
|
8 Participants
|
|
Proportion of Participants With a Pa Positive Culture
Missing
|
4 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured over the 18 month time periodPopulation: Intent to treat
The primary comparison is between the pooled culture-based group and the pooled cycled group. No interactions with ciprofloxacin were identified. A secondary comparison is between the pooled ciprofloxacin group vs the pooled placebo group. Descriptive results are provided for the pooled treatment groups. Participants are represented once in the cycled and culture-based therapy columns, and once in the cipro and placebo columns.
Outcome measures
| Measure |
Cycled TIS
n=152 Participants
Pooled Cycled tobramycin solution for inhalation (TIS) therapy group
|
Culture-Based TIS
n=152 Participants
Pooled Culture-Based TIS therapy group
|
Oral Ciprofloxacin
n=152 Participants
Pooled oral cipro group
|
Oral Placebo
n=152 Participants
Pooled oral placebo group
|
|---|---|---|---|---|
|
Number of Participants With a Pulmonary Exacerbation Requiring Oral, Inhaled, or Oral Antibiotics
|
70 participants
|
81 participants
|
83 participants
|
68 participants
|
Adverse Events
Cycled TIS w/Placebo
Serious events: 18 serious events
Other events: 65 other events
Deaths: 0 deaths
Cycled TIS w/Cipro
Serious events: 21 serious events
Other events: 67 other events
Deaths: 0 deaths
Culture-Based TIS w/Placebo
Serious events: 17 serious events
Other events: 65 other events
Deaths: 0 deaths
Culture-Based TIS w/Cipro
Serious events: 27 serious events
Other events: 73 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cycled TIS w/Placebo
n=76 participants at risk
TOBI and oral placebo for six consecutive quarterly cycles
|
Cycled TIS w/Cipro
n=76 participants at risk
TOBI and oral ciprofloxacin for six consecutive quarterly cycles
|
Culture-Based TIS w/Placebo
n=76 participants at risk
TOBI and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (PA)
|
Culture-Based TIS w/Cipro
n=76 participants at risk
TOBI and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for PA
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Discomfort
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.6%
2/76 • Number of events 2 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
2.6%
2/76 • Number of events 2 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Gastrointestinal disorders
Colitis
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
3.9%
3/76 • Number of events 6 • Randomization through Month 18
|
|
Gastrointestinal disorders
Distal Intestinal Obstruction Syndrome
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
|
Gastrointestinal disorders
Pancreatitis
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
|
General disorders
Chest Pain
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
General disorders
Fatigue
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
General disorders
Pyrexia
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 2 • Randomization through Month 18
|
2.6%
2/76 • Number of events 2 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Infections and infestations
Acute Sinusitis
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
|
Infections and infestations
Lobar Pneumonia
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
2.6%
2/76 • Number of events 2 • Randomization through Month 18
|
|
Infections and infestations
Pneumonia
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
|
Infections and infestations
Pseudomonas Infection
|
2.6%
2/76 • Number of events 2 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Infections and infestations
Streptococcal Infection
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
|
Injury, poisoning and procedural complications
Skull Fracture
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Investigations
Blood Urine Present
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Investigations
Body Temperature Increased
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Investigations
Breath Sounds Abnormal
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Investigations
Bronchoscopy
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Investigations
Forced Expiratory Volume Decreased
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Investigations
Pulmonary Function Test Decreased
|
3.9%
3/76 • Number of events 3 • Randomization through Month 18
|
2.6%
2/76 • Number of events 3 • Randomization through Month 18
|
1.3%
1/76 • Number of events 2 • Randomization through Month 18
|
2.6%
2/76 • Number of events 3 • Randomization through Month 18
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
|
Metabolism and nutrition disorders
Failure to Thrive
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
2.6%
2/76 • Number of events 3 • Randomization through Month 18
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Nervous system disorders
Convulsion
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.9%
3/76 • Number of events 4 • Randomization through Month 18
|
6.6%
5/76 • Number of events 9 • Randomization through Month 18
|
2.6%
2/76 • Number of events 2 • Randomization through Month 18
|
6.6%
5/76 • Number of events 7 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Oedema
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Polyps
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/76 • Randomization through Month 18
|
2.6%
2/76 • Number of events 2 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
2.6%
2/76 • Number of events 2 • Randomization through Month 18
|
1.3%
1/76 • Number of events 2 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Skin and subcutaneous tissue disorders
Erythema Nodosum
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Surgical and medical procedures
Adenotonsillectomy
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Surgical and medical procedures
Central Venous Catheterisation
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Surgical and medical procedures
Gastrointestinal Tube Insertion
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
|
Surgical and medical procedures
Gastrostomy Tube Insertion
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
|
Surgical and medical procedures
Nasal Polypectomy
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Surgical and medical procedures
Polypectomy
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Surgical and medical procedures
Sinus Operation
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
2.6%
2/76 • Number of events 2 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
|
Surgical and medical procedures
Tonsillectomy
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
|
Surgical and medical procedures
Vesicoureteral Reflux Surgery
|
0.00%
0/76 • Randomization through Month 18
|
1.3%
1/76 • Number of events 1 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
Other adverse events
| Measure |
Cycled TIS w/Placebo
n=76 participants at risk
TOBI and oral placebo for six consecutive quarterly cycles
|
Cycled TIS w/Cipro
n=76 participants at risk
TOBI and oral ciprofloxacin for six consecutive quarterly cycles
|
Culture-Based TIS w/Placebo
n=76 participants at risk
TOBI and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (PA)
|
Culture-Based TIS w/Cipro
n=76 participants at risk
TOBI and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for PA
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.5%
8/76 • Number of events 9 • Randomization through Month 18
|
9.2%
7/76 • Number of events 8 • Randomization through Month 18
|
15.8%
12/76 • Number of events 20 • Randomization through Month 18
|
10.5%
8/76 • Number of events 11 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
57.9%
44/76 • Number of events 88 • Randomization through Month 18
|
50.0%
38/76 • Number of events 68 • Randomization through Month 18
|
52.6%
40/76 • Number of events 85 • Randomization through Month 18
|
63.2%
48/76 • Number of events 98 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discomfort
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Mucosal Disorder
|
7.9%
6/76 • Number of events 8 • Randomization through Month 18
|
9.2%
7/76 • Number of events 9 • Randomization through Month 18
|
13.2%
10/76 • Number of events 12 • Randomization through Month 18
|
7.9%
6/76 • Number of events 6 • Randomization through Month 18
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
15.8%
12/76 • Number of events 13 • Randomization through Month 18
|
10.5%
8/76 • Number of events 8 • Randomization through Month 18
|
17.1%
13/76 • Number of events 14 • Randomization through Month 18
|
14.5%
11/76 • Number of events 12 • Randomization through Month 18
|
|
Ear and labyrinth disorders
Ear Pain
|
10.5%
8/76 • Number of events 13 • Randomization through Month 18
|
11.8%
9/76 • Number of events 11 • Randomization through Month 18
|
14.5%
11/76 • Number of events 18 • Randomization through Month 18
|
22.4%
17/76 • Number of events 19 • Randomization through Month 18
|
|
Ear and labyrinth disorders
Middle Ear Effusion
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
7.9%
6/76 • Number of events 8 • Randomization through Month 18
|
|
Ear and labyrinth disorders
Tympanic Membrane Disorder
|
7.9%
6/76 • Number of events 6 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/76 • Randomization through Month 18
|
7.9%
6/76 • Number of events 6 • Randomization through Month 18
|
13.2%
10/76 • Number of events 10 • Randomization through Month 18
|
5.3%
4/76 • Number of events 5 • Randomization through Month 18
|
|
Eye disorders
Eye Discharge
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 8 • Randomization through Month 18
|
|
Eye disorders
Ocular Hyperaemia
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 5 • Randomization through Month 18
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
9.2%
7/76 • Number of events 8 • Randomization through Month 18
|
6.6%
5/76 • Number of events 8 • Randomization through Month 18
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Gastrointestinal disorders
Abdominal Distension
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
5.3%
4/76 • Number of events 7 • Randomization through Month 18
|
|
Gastrointestinal disorders
Abdominal Pain
|
22.4%
17/76 • Number of events 20 • Randomization through Month 18
|
15.8%
12/76 • Number of events 15 • Randomization through Month 18
|
21.1%
16/76 • Number of events 21 • Randomization through Month 18
|
15.8%
12/76 • Number of events 15 • Randomization through Month 18
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
18.4%
14/76 • Number of events 22 • Randomization through Month 18
|
23.7%
18/76 • Number of events 34 • Randomization through Month 18
|
19.7%
15/76 • Number of events 35 • Randomization through Month 18
|
22.4%
17/76 • Number of events 30 • Randomization through Month 18
|
|
Gastrointestinal disorders
Constipation
|
7.9%
6/76 • Number of events 8 • Randomization through Month 18
|
11.8%
9/76 • Number of events 15 • Randomization through Month 18
|
17.1%
13/76 • Number of events 14 • Randomization through Month 18
|
14.5%
11/76 • Number of events 13 • Randomization through Month 18
|
|
Gastrointestinal disorders
Diarrhoea
|
19.7%
15/76 • Number of events 24 • Randomization through Month 18
|
28.9%
22/76 • Number of events 40 • Randomization through Month 18
|
28.9%
22/76 • Number of events 24 • Randomization through Month 18
|
34.2%
26/76 • Number of events 49 • Randomization through Month 18
|
|
Gastrointestinal disorders
Flatulence
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Gastrointestinal disorders
Frequent Bowel Movements
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
6.6%
5/76 • Number of events 6 • Randomization through Month 18
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
6.6%
5/76 • Number of events 5 • Randomization through Month 18
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/76 • Randomization through Month 18
|
15.8%
12/76 • Number of events 21 • Randomization through Month 18
|
7.9%
6/76 • Number of events 7 • Randomization through Month 18
|
9.2%
7/76 • Number of events 11 • Randomization through Month 18
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 6 • Randomization through Month 18
|
|
Gastrointestinal disorders
Post-Tussive Vomiting
|
6.6%
5/76 • Number of events 5 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Gastrointestinal disorders
Steatorrhoea
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 5 • Randomization through Month 18
|
|
Gastrointestinal disorders
Teething
|
5.3%
4/76 • Number of events 5 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
6.6%
5/76 • Number of events 5 • Randomization through Month 18
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 6 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Gastrointestinal disorders
Vomiting
|
38.2%
29/76 • Number of events 52 • Randomization through Month 18
|
39.5%
30/76 • Number of events 52 • Randomization through Month 18
|
46.1%
35/76 • Number of events 49 • Randomization through Month 18
|
48.7%
37/76 • Number of events 70 • Randomization through Month 18
|
|
General disorders
Asthenia
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
General disorders
Chest Pain
|
7.9%
6/76 • Number of events 8 • Randomization through Month 18
|
9.2%
7/76 • Number of events 8 • Randomization through Month 18
|
7.9%
6/76 • Number of events 8 • Randomization through Month 18
|
14.5%
11/76 • Number of events 15 • Randomization through Month 18
|
|
General disorders
Chills
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 5 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
General disorders
Crepitations
|
0.00%
0/76 • Randomization through Month 18
|
6.6%
5/76 • Number of events 6 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
|
General disorders
Exercise Tolerance Decreased
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
7.9%
6/76 • Number of events 7 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
General disorders
Fatigue
|
14.5%
11/76 • Number of events 19 • Randomization through Month 18
|
9.2%
7/76 • Number of events 9 • Randomization through Month 18
|
17.1%
13/76 • Number of events 21 • Randomization through Month 18
|
13.2%
10/76 • Number of events 14 • Randomization through Month 18
|
|
General disorders
Irritability
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
5.3%
4/76 • Number of events 5 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
10.5%
8/76 • Number of events 11 • Randomization through Month 18
|
|
General disorders
Pain
|
6.6%
5/76 • Number of events 6 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
General disorders
Pyrexia
|
60.5%
46/76 • Number of events 85 • Randomization through Month 18
|
59.2%
45/76 • Number of events 107 • Randomization through Month 18
|
75.0%
57/76 • Number of events 138 • Randomization through Month 18
|
75.0%
57/76 • Number of events 129 • Randomization through Month 18
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Infections and infestations
Conjunctivitis Infective
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 5 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Infections and infestations
Ear Infection
|
6.6%
5/76 • Number of events 6 • Randomization through Month 18
|
15.8%
12/76 • Number of events 17 • Randomization through Month 18
|
10.5%
8/76 • Number of events 8 • Randomization through Month 18
|
22.4%
17/76 • Number of events 25 • Randomization through Month 18
|
|
Infections and infestations
Influenza
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
4/76 • Number of events 6 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 6 • Randomization through Month 18
|
|
Infections and infestations
Otitis Media
|
22.4%
17/76 • Number of events 24 • Randomization through Month 18
|
9.2%
7/76 • Number of events 7 • Randomization through Month 18
|
27.6%
21/76 • Number of events 33 • Randomization through Month 18
|
19.7%
15/76 • Number of events 23 • Randomization through Month 18
|
|
Infections and infestations
Pharyngitis Streptococcal
|
9.2%
7/76 • Number of events 10 • Randomization through Month 18
|
11.8%
9/76 • Number of events 11 • Randomization through Month 18
|
7.9%
6/76 • Number of events 9 • Randomization through Month 18
|
14.5%
11/76 • Number of events 16 • Randomization through Month 18
|
|
Infections and infestations
Rhinitis
|
9.2%
7/76 • Number of events 10 • Randomization through Month 18
|
13.2%
10/76 • Number of events 12 • Randomization through Month 18
|
13.2%
10/76 • Number of events 11 • Randomization through Month 18
|
7.9%
6/76 • Number of events 11 • Randomization through Month 18
|
|
Infections and infestations
Sinusitis
|
17.1%
13/76 • Number of events 20 • Randomization through Month 18
|
17.1%
13/76 • Number of events 15 • Randomization through Month 18
|
14.5%
11/76 • Number of events 16 • Randomization through Month 18
|
28.9%
22/76 • Number of events 25 • Randomization through Month 18
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/76 • Randomization through Month 18
|
6.6%
5/76 • Number of events 6 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
6.6%
5/76 • Number of events 5 • Randomization through Month 18
|
6.6%
5/76 • Number of events 5 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Injury, poisoning and procedural complications
Contusion
|
6.6%
5/76 • Number of events 5 • Randomization through Month 18
|
6.6%
5/76 • Number of events 8 • Randomization through Month 18
|
5.3%
4/76 • Number of events 5 • Randomization through Month 18
|
7.9%
6/76 • Number of events 8 • Randomization through Month 18
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.3%
4/76 • Number of events 5 • Randomization through Month 18
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
9.2%
7/76 • Number of events 7 • Randomization through Month 18
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/76 • Randomization through Month 18
|
6.6%
5/76 • Number of events 6 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Investigations
Breath Sounds Abnormal
|
11.8%
9/76 • Number of events 13 • Randomization through Month 18
|
13.2%
10/76 • Number of events 15 • Randomization through Month 18
|
13.2%
10/76 • Number of events 13 • Randomization through Month 18
|
10.5%
8/76 • Number of events 8 • Randomization through Month 18
|
|
Investigations
Chest X-Ray Abnormal
|
10.5%
8/76 • Number of events 8 • Randomization through Month 18
|
9.2%
7/76 • Number of events 9 • Randomization through Month 18
|
11.8%
9/76 • Number of events 9 • Randomization through Month 18
|
10.5%
8/76 • Number of events 9 • Randomization through Month 18
|
|
Investigations
Forced Expiratory Volume Decreased
|
14.5%
11/76 • Number of events 16 • Randomization through Month 18
|
15.8%
12/76 • Number of events 15 • Randomization through Month 18
|
11.8%
9/76 • Number of events 10 • Randomization through Month 18
|
11.8%
9/76 • Number of events 11 • Randomization through Month 18
|
|
Investigations
Increased Anteroposterior Chest Diameter
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
6.6%
5/76 • Number of events 5 • Randomization through Month 18
|
5.3%
4/76 • Number of events 5 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Investigations
Methicillin-Resistant Staphylococcal Aureus Test Positive
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
|
Investigations
Pulmonary Function Test Decreased
|
5.3%
4/76 • Number of events 5 • Randomization through Month 18
|
6.6%
5/76 • Number of events 6 • Randomization through Month 18
|
6.6%
5/76 • Number of events 5 • Randomization through Month 18
|
11.8%
9/76 • Number of events 14 • Randomization through Month 18
|
|
Investigations
Respiratory Rate Increased
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
|
Investigations
Sputum Abnormal
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Investigations
Weight Decreased
|
9.2%
7/76 • Number of events 9 • Randomization through Month 18
|
13.2%
10/76 • Number of events 12 • Randomization through Month 18
|
7.9%
6/76 • Number of events 6 • Randomization through Month 18
|
18.4%
14/76 • Number of events 17 • Randomization through Month 18
|
|
Investigations
White Blood Cell Count Increased
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
6.6%
5/76 • Number of events 5 • Randomization through Month 18
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
22.4%
17/76 • Number of events 27 • Randomization through Month 18
|
11.8%
9/76 • Number of events 10 • Randomization through Month 18
|
11.8%
9/76 • Number of events 9 • Randomization through Month 18
|
26.3%
20/76 • Number of events 30 • Randomization through Month 18
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.4%
14/76 • Number of events 17 • Randomization through Month 18
|
18.4%
14/76 • Number of events 25 • Randomization through Month 18
|
18.4%
14/76 • Number of events 18 • Randomization through Month 18
|
15.8%
12/76 • Number of events 14 • Randomization through Month 18
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/76 • Randomization through Month 18
|
9.2%
7/76 • Number of events 8 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
6.6%
5/76 • Number of events 7 • Randomization through Month 18
|
|
Musculoskeletal and connective tissue disorders
Clubbing
|
9.2%
7/76 • Number of events 7 • Randomization through Month 18
|
19.7%
15/76 • Number of events 16 • Randomization through Month 18
|
9.2%
7/76 • Number of events 8 • Randomization through Month 18
|
10.5%
8/76 • Number of events 9 • Randomization through Month 18
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
6.6%
5/76 • Number of events 6 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 7 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
7.9%
6/76 • Number of events 6 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/76 • Randomization through Month 18
|
10.5%
8/76 • Number of events 8 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
9.2%
7/76 • Number of events 8 • Randomization through Month 18
|
19.7%
15/76 • Number of events 27 • Randomization through Month 18
|
13.2%
10/76 • Number of events 16 • Randomization through Month 18
|
15.8%
12/76 • Number of events 14 • Randomization through Month 18
|
|
Nervous system disorders
Dizziness
|
0.00%
0/76 • Randomization through Month 18
|
6.6%
5/76 • Number of events 7 • Randomization through Month 18
|
7.9%
6/76 • Number of events 6 • Randomization through Month 18
|
5.3%
4/76 • Number of events 7 • Randomization through Month 18
|
|
Nervous system disorders
Headache
|
50.0%
38/76 • Number of events 72 • Randomization through Month 18
|
36.8%
28/76 • Number of events 69 • Randomization through Month 18
|
31.6%
24/76 • Number of events 47 • Randomization through Month 18
|
40.8%
31/76 • Number of events 75 • Randomization through Month 18
|
|
Nervous system disorders
Lethargy
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
7.9%
6/76 • Number of events 7 • Randomization through Month 18
|
|
Psychiatric disorders
Decreased Activity
|
13.2%
10/76 • Number of events 11 • Randomization through Month 18
|
6.6%
5/76 • Number of events 5 • Randomization through Month 18
|
6.6%
5/76 • Number of events 5 • Randomization through Month 18
|
9.2%
7/76 • Number of events 7 • Randomization through Month 18
|
|
Renal and urinary disorders
Dysuria
|
5.3%
4/76 • Number of events 5 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
6.6%
5/76 • Number of events 5 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Wall Thickening
|
6.6%
5/76 • Number of events 5 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
81.6%
62/76 • Number of events 202 • Randomization through Month 18
|
82.9%
63/76 • Number of events 240 • Randomization through Month 18
|
85.5%
65/76 • Number of events 224 • Randomization through Month 18
|
93.4%
71/76 • Number of events 282 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
14.5%
11/76 • Number of events 16 • Randomization through Month 18
|
21.1%
16/76 • Number of events 28 • Randomization through Month 18
|
15.8%
12/76 • Number of events 26 • Randomization through Month 18
|
19.7%
15/76 • Number of events 22 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.6%
5/76 • Number of events 6 • Randomization through Month 18
|
10.5%
8/76 • Number of events 9 • Randomization through Month 18
|
17.1%
13/76 • Number of events 19 • Randomization through Month 18
|
9.2%
7/76 • Number of events 9 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Oedema
|
10.5%
8/76 • Number of events 10 • Randomization through Month 18
|
10.5%
8/76 • Number of events 9 • Randomization through Month 18
|
11.8%
9/76 • Number of events 11 • Randomization through Month 18
|
15.8%
12/76 • Number of events 13 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Polyps
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
10.5%
8/76 • Number of events 9 • Randomization through Month 18
|
11.8%
9/76 • Number of events 10 • Randomization through Month 18
|
9.2%
7/76 • Number of events 7 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
25.0%
19/76 • Number of events 31 • Randomization through Month 18
|
34.2%
26/76 • Number of events 51 • Randomization through Month 18
|
31.6%
24/76 • Number of events 36 • Randomization through Month 18
|
36.8%
28/76 • Number of events 59 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Erythema
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
6.6%
5/76 • Number of events 5 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
6.6%
5/76 • Number of events 5 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
22.4%
17/76 • Number of events 23 • Randomization through Month 18
|
30.3%
23/76 • Number of events 40 • Randomization through Month 18
|
28.9%
22/76 • Number of events 38 • Randomization through Month 18
|
36.8%
28/76 • Number of events 48 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
13.2%
10/76 • Number of events 11 • Randomization through Month 18
|
17.1%
13/76 • Number of events 19 • Randomization through Month 18
|
14.5%
11/76 • Number of events 16 • Randomization through Month 18
|
15.8%
12/76 • Number of events 16 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
9.2%
7/76 • Number of events 8 • Randomization through Month 18
|
22.4%
17/76 • Number of events 32 • Randomization through Month 18
|
17.1%
13/76 • Number of events 15 • Randomization through Month 18
|
17.1%
13/76 • Number of events 18 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
53.9%
41/76 • Number of events 100 • Randomization through Month 18
|
63.2%
48/76 • Number of events 123 • Randomization through Month 18
|
61.8%
47/76 • Number of events 119 • Randomization through Month 18
|
65.8%
50/76 • Number of events 139 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
7.9%
6/76 • Number of events 6 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
6.6%
5/76 • Number of events 7 • Randomization through Month 18
|
7.9%
6/76 • Number of events 6 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
6.6%
5/76 • Number of events 6 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
6.6%
5/76 • Number of events 7 • Randomization through Month 18
|
7.9%
6/76 • Number of events 6 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
6.6%
5/76 • Number of events 6 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Sputum Discolored
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 8 • Randomization through Month 18
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar Hypertrophy
|
11.8%
9/76 • Number of events 9 • Randomization through Month 18
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
9.2%
7/76 • Number of events 7 • Randomization through Month 18
|
6.6%
5/76 • Number of events 6 • Randomization through Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
23.7%
18/76 • Number of events 24 • Randomization through Month 18
|
19.7%
15/76 • Number of events 24 • Randomization through Month 18
|
15.8%
12/76 • Number of events 16 • Randomization through Month 18
|
22.4%
17/76 • Number of events 22 • Randomization through Month 18
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
6.6%
5/76 • Number of events 5 • Randomization through Month 18
|
|
Skin and subcutaneous tissue disorders
Dermatitis Diaper
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
13.2%
10/76 • Number of events 18 • Randomization through Month 18
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.3%
4/76 • Number of events 4 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
5.3%
4/76 • Number of events 7 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.5%
11/76 • Number of events 15 • Randomization through Month 18
|
17.1%
13/76 • Number of events 18 • Randomization through Month 18
|
21.1%
16/76 • Number of events 21 • Randomization through Month 18
|
21.1%
16/76 • Number of events 19 • Randomization through Month 18
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.3%
4/76 • Number of events 5 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
|
Surgical and medical procedures
Sinus Operation
|
0.00%
0/76 • Randomization through Month 18
|
9.2%
7/76 • Number of events 7 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
0.00%
0/76 • Randomization through Month 18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place