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Trial Outcomes & Findings for Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years (NCT NCT01082367)

NCT ID: NCT01082367

Last Updated: 2016-07-15

Results Overview

Sputum/throat swab cultures were assessed.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

50 participants

Primary outcome timeframe

Day 29

Results posted on

2016-07-15

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure
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.
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.
Double-blind Period
STARTED
26
25
Double-blind Period
Stage 1:1st Treatment (tx) Cycle
26
25
Double-blind Period
Stage 2:no tx
0
0
Double-blind Period
Entered OL TOBI
4
18
Double-blind Period
P.A-free,Day 29 w/ no Cross-over
9
0
Double-blind Period
Stage 3: Cross-over (co) tx
13
6
Double-blind Period
Stage 4:no tx for Patients Not in co
0
0
Double-blind Period
COMPLETED
21
12
Double-blind Period
NOT COMPLETED
5
13
Follow-up (F-U) Period
STARTED
19
10
Follow-up (F-U) Period
Treated in F-U
5
5
Follow-up (F-U) Period
COMPLETED
17
9
Follow-up (F-U) Period
NOT COMPLETED
2
1

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
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.
Double-blind Period
Administrative problems
0
1
Double-blind Period
Lack of Efficacy
5
11
Double-blind Period
Adverse Event
0
1
Follow-up (F-U) Period
Administrative problems
1
0
Follow-up (F-U) Period
Abnormal lab values
1
0
Follow-up (F-U) Period
Adverse Event
0
1

Baseline Characteristics

Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
TOBI (Tobramycin Inhaled Solution)/Placebo
n=26 Participants
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.
Placebo/TOBI
n=25 Participants
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.
Total
n=51 Participants
Total of all reporting groups
Age, Continuous
2.9 Years
STANDARD_DEVIATION 1.96 • n=5 Participants
2.7 Years
STANDARD_DEVIATION 1.93 • n=7 Participants
2.8 Years
STANDARD_DEVIATION 1.93 • n=5 Participants
Sex: Female, Male
Female
15 Participants
n=5 Participants
17 Participants
n=7 Participants
32 Participants
n=5 Participants
Sex: Female, Male
Male
11 Participants
n=5 Participants
8 Participants
n=7 Participants
19 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Day 29

Population: Intent-to-treat (ITT): The ITT included all randomized participants who received at least dose of study treatment.

Sputum/throat swab cultures were assessed.

Outcome measures

Outcome measures
Measure
TOBI (Tobramycin Inhaled Solution)/Placebo
n=26 Participants
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.
Placebo/TOBI
n=25 Participants
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.
Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle
84.6 Percentage of participants
24.0 Percentage of participants

SECONDARY outcome

Timeframe: Day 91

Population: Cross-over participants from the ITT population were analyzed.

Sputum/throat swab cultures were assessed.

Outcome measures

Outcome measures
Measure
TOBI (Tobramycin Inhaled Solution)/Placebo
n=13 Participants
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.
Placebo/TOBI
n=6 Participants
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.
Percentage of Participants Free From P. Aeruginosa 28 Days After Termination of the Second Treatment Cycle
92.3 Percentage of participants
83.3 Percentage of participants

SECONDARY outcome

Timeframe: Day 91

Population: Participants from the ITT population, who were tested for microbiology, were included in the analysis.

Sputum/throat swab cultures were assessed.

Outcome measures

Outcome measures
Measure
TOBI (Tobramycin Inhaled Solution)/Placebo
n=25 Participants
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.
Placebo/TOBI
n=22 Participants
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.
Percentage of Participants P Aeruginosa-free at Termination of the Double Blind Period
76.0 Percentage of participants
47.8 Percentage of participants

Adverse Events

DB TOBI

Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths

DB Placebo

Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths

OL TOBI (Core)

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

Off-treatment (Core)

Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths

OL TOBI (Follow-up)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Off-treatment (Follow-up)

Serious events: 4 serious events
Other events: 23 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
DB TOBI
n=32 participants at risk
DB TOBI
DB Placebo
n=38 participants at risk
DB Placebo
OL TOBI (Core)
n=22 participants at risk
OL TOBI (core)
Off-treatment (Core)
n=50 participants at risk
Off-treatment (core)
OL TOBI (Follow-up)
n=10 participants at risk
OL TOBI (follow-up)
Off-treatment (Follow-up)
n=29 participants at risk
Off-treatment (follow-up)
Blood and lymphatic system disorders
Haemolytic anaemia
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Congenital, familial and genetic disorders
Glucose-6-phosphate dehydrogenase deficiency
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Infections and infestations
Bacterial disease carrier
0.00%
0/32
0.00%
0/38
0.00%
0/22
2.0%
1/50
0.00%
0/10
0.00%
0/29
Infections and infestations
Bronchopneumonia
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Infections and infestations
Croup infectious
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Infections and infestations
Laryngitis
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Infections and infestations
Lower respiratory tract infection bacterial
0.00%
0/32
0.00%
0/38
0.00%
0/22
2.0%
1/50
0.00%
0/10
0.00%
0/29
Infections and infestations
Pseudomonas infection
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Infections and infestations
Staphylococcal infection
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Infections and infestations
Upper respiratory tract infection bacterial
0.00%
0/32
2.6%
1/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
0.00%
0/29
Respiratory, thoracic and mediastinal disorders
Stridor
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Vascular disorders
Hypertension
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29

Other adverse events

Other adverse events
Measure
DB TOBI
n=32 participants at risk
DB TOBI
DB Placebo
n=38 participants at risk
DB Placebo
OL TOBI (Core)
n=22 participants at risk
OL TOBI (core)
Off-treatment (Core)
n=50 participants at risk
Off-treatment (core)
OL TOBI (Follow-up)
n=10 participants at risk
OL TOBI (follow-up)
Off-treatment (Follow-up)
n=29 participants at risk
Off-treatment (follow-up)
Ear and labyrinth disorders
Ear pain
3.1%
1/32
2.6%
1/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
0.00%
0/29
Eye disorders
Eye discharge
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Gastrointestinal disorders
Abdominal distension
0.00%
0/32
2.6%
1/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Gastrointestinal disorders
Abdominal pain
0.00%
0/32
0.00%
0/38
4.5%
1/22
0.00%
0/50
0.00%
0/10
17.2%
5/29
Gastrointestinal disorders
Constipation
0.00%
0/32
0.00%
0/38
0.00%
0/22
2.0%
1/50
0.00%
0/10
13.8%
4/29
Gastrointestinal disorders
Diarrhoea
3.1%
1/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Gastrointestinal disorders
Faeces soft
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
6.9%
2/29
Gastrointestinal disorders
Oral mucosal eruption
0.00%
0/32
0.00%
0/38
4.5%
1/22
0.00%
0/50
0.00%
0/10
0.00%
0/29
Gastrointestinal disorders
Teething
6.2%
2/32
0.00%
0/38
0.00%
0/22
2.0%
1/50
0.00%
0/10
0.00%
0/29
Gastrointestinal disorders
Toothache
3.1%
1/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
0.00%
0/29
Gastrointestinal disorders
Vomiting
0.00%
0/32
7.9%
3/38
0.00%
0/22
2.0%
1/50
0.00%
0/10
13.8%
4/29
General disorders
Asthenia
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
General disorders
Pyrexia
6.2%
2/32
7.9%
3/38
9.1%
2/22
10.0%
5/50
0.00%
0/10
34.5%
10/29
Immune system disorders
Food allergy
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Immune system disorders
Seasonal allergy
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Infections and infestations
Bronchitis
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
6.9%
2/29
Infections and infestations
Conjunctivitis
3.1%
1/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
0.00%
0/29
Infections and infestations
Ear infection
0.00%
0/32
2.6%
1/38
4.5%
1/22
2.0%
1/50
0.00%
0/10
13.8%
4/29
Infections and infestations
Eye infection
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Infections and infestations
Gastroenteritis
0.00%
0/32
2.6%
1/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Infections and infestations
Lobar pneumonia
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Infections and infestations
Lower respiratory tract infection bacterial
0.00%
0/32
0.00%
0/38
4.5%
1/22
0.00%
0/50
0.00%
0/10
0.00%
0/29
Infections and infestations
Lung infection
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Infections and infestations
Nasopharyngitis
0.00%
0/32
2.6%
1/38
4.5%
1/22
0.00%
0/50
0.00%
0/10
17.2%
5/29
Infections and infestations
Otitis media
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Infections and infestations
Perineal infection
3.1%
1/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
0.00%
0/29
Infections and infestations
Pharyngitis
0.00%
0/32
0.00%
0/38
0.00%
0/22
2.0%
1/50
0.00%
0/10
3.4%
1/29
Infections and infestations
Pseudomonas infection
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Infections and infestations
Respiratory tract infection
3.1%
1/32
0.00%
0/38
4.5%
1/22
0.00%
0/50
0.00%
0/10
6.9%
2/29
Infections and infestations
Respiratory tract infection viral
0.00%
0/32
7.9%
3/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
0.00%
0/29
Infections and infestations
Rhinitis
0.00%
0/32
2.6%
1/38
0.00%
0/22
4.0%
2/50
0.00%
0/10
0.00%
0/29
Infections and infestations
Staphylococcal infection
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Infections and infestations
Tonsillitis
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Infections and infestations
Urinary tract infection
0.00%
0/32
0.00%
0/38
4.5%
1/22
0.00%
0/50
0.00%
0/10
0.00%
0/29
Infections and infestations
Varicella
0.00%
0/32
2.6%
1/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Injury, poisoning and procedural complications
Foreign body
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Injury, poisoning and procedural complications
Upper limb fracture
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Investigations
Acinetobacter test positive
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Investigations
Alanine aminotransferase increased
0.00%
0/32
5.3%
2/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
0.00%
0/29
Investigations
Aspergillus test positive
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Investigations
Pseudomonas test positive
0.00%
0/32
2.6%
1/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
6.9%
2/29
Investigations
Streptococcus test positive
0.00%
0/32
0.00%
0/38
4.5%
1/22
0.00%
0/50
0.00%
0/10
0.00%
0/29
Metabolism and nutrition disorders
Decreased appetite
3.1%
1/32
2.6%
1/38
0.00%
0/22
2.0%
1/50
0.00%
0/10
0.00%
0/29
Nervous system disorders
Headache
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Nervous system disorders
Lethargy
0.00%
0/32
0.00%
0/38
4.5%
1/22
0.00%
0/50
0.00%
0/10
0.00%
0/29
Psychiatric disorders
Bruxism
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Psychiatric disorders
Restlessness
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Respiratory, thoracic and mediastinal disorders
Bronchospasm
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Respiratory, thoracic and mediastinal disorders
Catarrh
0.00%
0/32
2.6%
1/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
6.9%
2/29
Respiratory, thoracic and mediastinal disorders
Cough
12.5%
4/32
15.8%
6/38
18.2%
4/22
6.0%
3/50
10.0%
1/10
41.4%
12/29
Respiratory, thoracic and mediastinal disorders
Dysphonia
3.1%
1/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
0.00%
0/29
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
6.9%
2/29
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
0.00%
0/32
0.00%
0/38
4.5%
1/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/32
0.00%
0/38
0.00%
0/22
2.0%
1/50
10.0%
1/10
10.3%
3/29
Respiratory, thoracic and mediastinal disorders
Nasal dryness
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/32
0.00%
0/38
4.5%
1/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
3.1%
1/32
2.6%
1/38
9.1%
2/22
8.0%
4/50
0.00%
0/10
24.1%
7/29
Respiratory, thoracic and mediastinal disorders
Snoring
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Respiratory, thoracic and mediastinal disorders
Wheezing
3.1%
1/32
0.00%
0/38
0.00%
0/22
2.0%
1/50
10.0%
1/10
3.4%
1/29
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
3.4%
1/29
Skin and subcutaneous tissue disorders
Rash
3.1%
1/32
2.6%
1/38
0.00%
0/22
2.0%
1/50
0.00%
0/10
3.4%
1/29
Skin and subcutaneous tissue disorders
Rash generalised
3.1%
1/32
0.00%
0/38
0.00%
0/22
0.00%
0/50
0.00%
0/10
0.00%
0/29

Additional Information

Study Director

Novartis

Phone: 862-778-8300

Results disclosure agreements

  • Principal investigator is a sponsor employee 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.
  • Publication restrictions are in place

Restriction type: OTHER