Trial Outcomes & Findings for Long Term Administration of Inhaled Mannitol in Cystic Fibrosis (NCT NCT00630812)
NCT ID: NCT00630812
Last Updated: 2020-10-09
Results Overview
Change from baseline in forced expiratory volume at one second (FEV1) averaged over 26 weeks (measured at 6,14 and 26 weeks) The mean absolute change from baseline FEV1 (mL) over 26 weeks (measured at week 6, 14 and 26) will be compared between the two treatment groups with a REML (restricted maximum likelihood) based repeated measures approach.Least square means presented are for the average change over the 6, 14, and 26 week visits.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
318 participants
Primary outcome timeframe
26 weeks
Results posted on
2020-10-09
Participant Flow
Patients underwent a mannitol tolerance test (MTT) to gauge tolerance to a test dose of mannitol. 318 patients were then randomised - only 305 of the randomised patients went on to receive a dose of study medication. Patients who did not start medication (13) were not included in the modified ITT population (mITT)
Participant milestones
| Measure |
Mannitol 400mg
active treatment
inhaled mannitol: 400 mg twice a day (BD) for 26 + 26 weeks
|
Control
Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
|
|---|---|---|
|
Randomisation to First Dose
STARTED
|
192
|
126
|
|
Randomisation to First Dose
COMPLETED
|
184
|
121
|
|
Randomisation to First Dose
NOT COMPLETED
|
8
|
5
|
|
Double Blind Treatment Period
STARTED
|
184
|
121
|
|
Double Blind Treatment Period
COMPLETED
|
153
|
107
|
|
Double Blind Treatment Period
NOT COMPLETED
|
31
|
14
|
Reasons for withdrawal
| Measure |
Mannitol 400mg
active treatment
inhaled mannitol: 400 mg twice a day (BD) for 26 + 26 weeks
|
Control
Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
|
|---|---|---|
|
Randomisation to First Dose
Adverse Event
|
1
|
1
|
|
Randomisation to First Dose
Withdrawal by Subject
|
2
|
3
|
|
Randomisation to First Dose
Lost to Follow-up
|
1
|
0
|
|
Randomisation to First Dose
Protocol Violation
|
4
|
1
|
|
Double Blind Treatment Period
Adverse Event
|
13
|
5
|
|
Double Blind Treatment Period
Lost to Follow-up
|
1
|
0
|
|
Double Blind Treatment Period
Physician Decision
|
2
|
1
|
|
Double Blind Treatment Period
Protocol Violation
|
1
|
0
|
|
Double Blind Treatment Period
Withdrawal by Subject
|
13
|
7
|
|
Double Blind Treatment Period
Wanted to take drug in non-protocol way
|
1
|
0
|
|
Double Blind Treatment Period
Non-compliance
|
0
|
1
|
Baseline Characteristics
Long Term Administration of Inhaled Mannitol in Cystic Fibrosis
Baseline characteristics by cohort
| Measure |
Mannitol 400mg
n=184 Participants
active treatment
inhaled mannitol: 400 mg BD for 26 + 26 weeks
|
Control
n=121 Participants
Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
|
Total
n=305 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Hospitalisations in year prior to study participation
3 hospitalisations
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Hospitalisations in year prior to study participation
>3 hospitalisations
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
91 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
93 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
182 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
301 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
48 participants
n=5 Participants
|
32 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
10 participants
n=5 Participants
|
6 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
85 participants
n=5 Participants
|
54 participants
n=7 Participants
|
139 participants
n=5 Participants
|
|
Region of Enrollment
France
|
14 participants
n=5 Participants
|
9 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
14 participants
n=5 Participants
|
9 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Hospitalisations in year prior to study participation
0 hospitalisations
|
114 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Hospitalisations in year prior to study participation
1 hospitalisation
|
41 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Hospitalisations in year prior to study participation
2 hospitalisations
|
21 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Pulmonary exacerbations in year prior to study participation
0 exacerbations
|
104 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Pulmonary exacerbations in year prior to study participation
1 exacerbation
|
45 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Pulmonary exacerbations in year prior to study participation
2 exacerbations
|
26 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Pulmonary exacerbations in year prior to study participation
3 exacerbations
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Pulmonary exacerbations in year prior to study participation
>3 exacerbations
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
CF mutation
Both deltaF508
|
77 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
CF mutation
One deltaF508
|
57 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
CF mutation
At least one other known mutation
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
CF mutation
Both unknown
|
35 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: mITT (modified intent to treat) - patients randomised and treated with at least one dose of study medication)
Change from baseline in forced expiratory volume at one second (FEV1) averaged over 26 weeks (measured at 6,14 and 26 weeks) The mean absolute change from baseline FEV1 (mL) over 26 weeks (measured at week 6, 14 and 26) will be compared between the two treatment groups with a REML (restricted maximum likelihood) based repeated measures approach.Least square means presented are for the average change over the 6, 14, and 26 week visits.
Outcome measures
| Measure |
Mannitol 400mg
n=184 Participants
active treatment
inhaled mannitol: 400 mg BD for 26 + 26 weeks
|
Control
n=121 Participants
Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
|
|---|---|---|
|
Change in Absolute FEV1 From Baseline Over 26 Weeks
|
106.53 mL
Interval 62.43 to 150.62
|
52.38 mL
Interval 2.09 to 102.68
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Note these are subset of dornase users - effect in dornase users was estimated using a model fitted using data from all patients
In the subset of dornase users, the mean absolute change from baseline FEV1 (mL) averaged over 26 weeks (measured at week 6, 14 and 26) will be compared between the two treatment groups with a REML (restricted maximum likelihood) based repeated measures approach. Least square means presented are for the average change over the 6, 14, and 26 week visits. Change from baseline over 26 weeks (measured at 6,14, 26 weeks) in subset of dornase users
Outcome measures
| Measure |
Mannitol 400mg
n=137 Participants
active treatment
inhaled mannitol: 400 mg BD for 26 + 26 weeks
|
Control
n=92 Participants
Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
|
|---|---|---|
|
Change in FEV1 From Baseline Over 26 Weeks - Dornase Users
|
78.60 mL
Interval 27.64 to 129.56
|
35.11 mL
Interval -20.99 to 91.21
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: mITT (randomised and treated)
Exacerbations treated with IV antibiotics and with at least 4 signs and symptoms according to Fuchs criteria (1994). Summary table presents the number with 0, 1,2 and 3 PDPEs during the 26 week treatment period.
Outcome measures
| Measure |
Mannitol 400mg
n=184 Participants
active treatment
inhaled mannitol: 400 mg BD for 26 + 26 weeks
|
Control
n=121 Participants
Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
|
|---|---|---|
|
Rate of Protocol Defined Pulmonary Exacerbations (PDPE)
With 1 PDPE
|
21 Participants
|
18 Participants
|
|
Rate of Protocol Defined Pulmonary Exacerbations (PDPE)
With 2 PDPE
|
6 Participants
|
4 Participants
|
|
Rate of Protocol Defined Pulmonary Exacerbations (PDPE)
With 3 PDPE
|
1 Participants
|
1 Participants
|
|
Rate of Protocol Defined Pulmonary Exacerbations (PDPE)
No PDPEs
|
156 Participants
|
98 Participants
|
SECONDARY outcome
Timeframe: 26 weeksThe number of hospitalisations is summarised and then the rate per person is analysed.
Outcome measures
| Measure |
Mannitol 400mg
n=184 Participants
active treatment
inhaled mannitol: 400 mg BD for 26 + 26 weeks
|
Control
n=121 Participants
Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
|
|---|---|---|
|
Hospitalisations Associated With Protocol Defined Pulmonary Exacerbations (PDPEs)
0 hospitalisations
|
162 Participants
|
102 Participants
|
|
Hospitalisations Associated With Protocol Defined Pulmonary Exacerbations (PDPEs)
1 hospitalisation
|
18 Participants
|
14 Participants
|
|
Hospitalisations Associated With Protocol Defined Pulmonary Exacerbations (PDPEs)
2 hospitalisations
|
3 Participants
|
5 Participants
|
|
Hospitalisations Associated With Protocol Defined Pulmonary Exacerbations (PDPEs)
3 hospitalisations
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 26 weeksNumber of courses per person in the 26 week period is summarised and then the rate per person analysed.
Outcome measures
| Measure |
Mannitol 400mg
n=184 Participants
active treatment
inhaled mannitol: 400 mg BD for 26 + 26 weeks
|
Control
n=121 Participants
Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
|
|---|---|---|
|
Antibiotic Use Associated With PDPEs
0 courses
|
156 Participants
|
98 Participants
|
|
Antibiotic Use Associated With PDPEs
1 course
|
22 Participants
|
19 Participants
|
|
Antibiotic Use Associated With PDPEs
2 courses
|
5 Participants
|
2 Participants
|
|
Antibiotic Use Associated With PDPEs
3 courses
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Baseline Observation carried forward (BOCF) implemented for those with missing values at visit 4
Change from baseline at 26 weeks in FEV1 percent predicted with BOCF for those with missing values at week 26
Outcome measures
| Measure |
Mannitol 400mg
n=184 Participants
active treatment
inhaled mannitol: 400 mg BD for 26 + 26 weeks
|
Control
n=121 Participants
Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
|
|---|---|---|
|
Absolute Change in FEV1 Percent Predicted at 26 Weeks
|
3.14 % of predicted
Interval 1.49 to 4.78
|
0.72 % of predicted
Interval -1.18 to 2.62
|
SECONDARY outcome
Timeframe: 26 weeksChange from baseline in forced vital capacity (FVC) across 26 weeks (measured at 6,14 and 26 weeks)
Outcome measures
| Measure |
Mannitol 400mg
n=184 Participants
active treatment
inhaled mannitol: 400 mg BD for 26 + 26 weeks
|
Control
n=121 Participants
Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
|
|---|---|---|
|
Change in FVC (mL) Across 26 Weeks
|
136.33 mL
Interval 88.54 to 184.11
|
64.98 mL
Interval 10.58 to 119.37
|
SECONDARY outcome
Timeframe: 26 weeksChange from baseline in forced expiratory flow at 25-75% of forced vital capacity (FEF25-75) (mL/s) averaged over 26 weeks (measured at 6,14 and 26 weeks) The mean absolute change from baseline over 26 weeks (measured at week 6, 14 and 26) was compared between the two treatment groups with a REML (restricted maximum likelihood) based repeated measures approach. Least square means presented are for the average change over the 6, 14, and 26 week visits.
Outcome measures
| Measure |
Mannitol 400mg
n=184 Participants
active treatment
inhaled mannitol: 400 mg BD for 26 + 26 weeks
|
Control
n=121 Participants
Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
|
|---|---|---|
|
Change From Baseline FEF25-75 (mL/s) Over 26 Weeks
|
84.65 mL/s
Interval 6.66 to 162.63
|
50.31 mL/s
Interval -38.24 to 138.86
|
SECONDARY outcome
Timeframe: up to 30 mins after first dose of trial treatmentPopulation: Patients randomised and treated who have sputum weight results available.
Sputum was collected during and for 30 minutes following the administration of the first dose of study treatment.
Outcome measures
| Measure |
Mannitol 400mg
n=180 Participants
active treatment
inhaled mannitol: 400 mg BD for 26 + 26 weeks
|
Control
n=114 Participants
Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
|
|---|---|---|
|
Sputum Weight at Baseline in Response to First Dose of Treatment
|
4.9 g
Standard Deviation 6.18
|
3.5 g
Standard Deviation 4.40
|
Adverse Events
Mannitol 400mg
Serious events: 31 serious events
Other events: 165 other events
Deaths: 0 deaths
Control
Serious events: 30 serious events
Other events: 106 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Mannitol 400mg
n=184 participants at risk
active treatment
inhaled mannitol: 400 mg BD for 26 + 26 weeks
|
Control
n=121 participants at risk
Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
|
|---|---|---|
|
General disorders
Condition Aggravated
|
14.7%
27/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
16.5%
20/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.1%
2/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
0.00%
0/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic Crisis
|
0.00%
0/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
0.83%
1/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.00%
0/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
0.83%
1/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
0.83%
1/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Infections and infestations
Bronchopneumonia
|
0.54%
1/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
0.00%
0/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
2.5%
3/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
0.83%
1/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Infections and infestations
Appendicitis
|
0.00%
0/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
0.83%
1/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Infections and infestations
Pneumonia
|
0.00%
0/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
0.83%
1/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
0.83%
1/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
0.83%
1/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Gastrointestinal disorders
Pancreatitis
|
0.54%
1/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
0.00%
0/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Gastrointestinal disorders
Distal intestinal obstruction syndrome
|
0.00%
0/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
0.83%
1/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
0.83%
1/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Gastrointestinal disorders
Pancreatis acute
|
0.00%
0/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
0.83%
1/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
0.83%
1/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Hepatobiliary disorders
Cholecystitis
|
0.54%
1/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
0.00%
0/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.54%
1/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
0.00%
0/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
Other adverse events
| Measure |
Mannitol 400mg
n=184 participants at risk
active treatment
inhaled mannitol: 400 mg BD for 26 + 26 weeks
|
Control
n=121 participants at risk
Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
|
|---|---|---|
|
General disorders
Condition Aggravated
|
31.0%
57/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
33.9%
41/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.2%
28/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
13.2%
16/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Nervous system disorders
Headache
|
14.1%
26/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
18.2%
22/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
10.3%
19/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
10.7%
13/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
General disorders
Pyrexia
|
9.2%
17/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
10.7%
13/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Gastrointestinal disorders
Abdominal pain
|
7.6%
14/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
6.6%
8/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.0%
11/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
2.5%
3/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
11/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
5.0%
6/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
10/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
9.1%
11/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Infections and infestations
Sinusitis
|
4.3%
8/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
5.8%
7/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.3%
6/184 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
5.8%
7/121 • 26 weeks
Safety information reported is for the 26 week double blind period only
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place