Trial Outcomes & Findings for A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects (NCT NCT02134353)
NCT ID: NCT02134353
Last Updated: 2020-10-28
Results Overview
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. Missing values due to withdrawal for reasons related to safety or efficacy were imputed using a baseline observation carried forward approach (BOCF).
COMPLETED
PHASE3
423 participants
26 weeks
2020-10-28
Participant Flow
Participant milestones
| Measure |
Experimental Arm A
Active treatment. Inhaled Mannitol
Inhaled mannitol: Inhaled mannitol 400 mg twice a day (BD) for 26 weeks
|
Arm B - Control
Arm B
Control (mannitol 50mg) twice a day (BD) for 26 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
209
|
214
|
|
Overall Study
COMPLETED
|
183
|
190
|
|
Overall Study
NOT COMPLETED
|
26
|
24
|
Reasons for withdrawal
| Measure |
Experimental Arm A
Active treatment. Inhaled Mannitol
Inhaled mannitol: Inhaled mannitol 400 mg twice a day (BD) for 26 weeks
|
Arm B - Control
Arm B
Control (mannitol 50mg) twice a day (BD) for 26 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
12
|
13
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Relocation
|
1
|
0
|
|
Overall Study
Other - Patient's Choice
|
0
|
1
|
Baseline Characteristics
A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects
Baseline characteristics by cohort
| Measure |
Experimental Arm A
n=209 Participants
Active treatment. Inhaled Mannitol
Inhaled mannitol: Inhaled mannitol 400 mg BD for 26 weeks
|
Arm B - Control
n=214 Participants
Arm B
Control BD (mannitol 50mg) for 26 weeks
|
Total
n=423 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Region of Enrollment
New Zealand
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Age, Continuous
|
26.8 years
STANDARD_DEVIATION 7.63 • n=5 Participants
|
28.6 years
STANDARD_DEVIATION 10.75 • n=7 Participants
|
27.7 years
STANDARD_DEVIATION 9.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
195 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
402 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
202 Participants
n=5 Participants
|
209 Participants
n=7 Participants
|
411 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=5 Participants
|
59 participants
n=7 Participants
|
116 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
31 participants
n=5 Participants
|
32 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
%Predicted FEV1 at Screening
>80% to <=90%
|
31 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
%Predicted FEV1 at Screening
>70% to <=80%
|
54 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
%Predicted FEV1 at Screening
>40% to <=70%
|
124 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
259 Participants
n=5 Participants
|
|
CFTR Mutation
Both deltaF508
|
55 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
CFTR Mutation
One deltaF508
|
91 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
CFTR Mutation
At least one other known mutation
|
28 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
CFTR Mutation
Both unknown
|
35 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Hospitalisations due to exacerbations in 12 months prior to screening
0
|
121 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
256 Participants
n=5 Participants
|
|
Hospitalisations due to exacerbations in 12 months prior to screening
1
|
57 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Hospitalisations due to exacerbations in 12 months prior to screening
2
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Hospitalisations due to exacerbations in 12 months prior to screening
3
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Hospitalisations due to exacerbations in 12 months prior to screening
4
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Hospitalisations due to exacerbations in 12 months prior to screening
>4
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Exacerbations treated with IV antibiotics in 12 months before screening
0
|
109 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
|
Exacerbations treated with IV antibiotics in 12 months before screening
1
|
58 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Exacerbations treated with IV antibiotics in 12 months before screening
2
|
28 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Exacerbations treated with IV antibiotics in 12 months before screening
3
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Exacerbations treated with IV antibiotics in 12 months before screening
4
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Exacerbations treated with IV antibiotics in 12 months before screening
>4
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 26 weeksThe 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. Missing values due to withdrawal for reasons related to safety or efficacy were imputed using a baseline observation carried forward approach (BOCF).
Outcome measures
| Measure |
Experimental Arm A
n=209 Participants
Active treatment. Inhaled Mannitol
Inhaled mannitol: Inhaled mannitol 400 mg BD for 26 weeks
|
Arm B - Control
n=214 Participants
Arm B
Control BD (mannitol 50mg) for 26 weeks
|
|---|---|---|
|
Mean Change in FEV1 (mL) From Baseline (Visit 1) Over the 26-week Treatment Period (to Visit 4).
|
63 mL
Interval 25.0 to 100.0
|
8 mL
Interval -27.0 to 44.0
|
SECONDARY outcome
Timeframe: 26 weeksTo determine whether inhaled mannitol (400 mg b.i.d.) is superior to control for improving lung function as measured by mean change from baseline forced vital capacity (FVC) (mL) over the 26-week treatment period in adult subjects with cystic fibrosis (CF). The mean absolute change from baseline FVC (mL) over 26 weeks 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 change from baseline averaged over the treatment period (ie the average of the changes at 6 weeks, 14 weeks and 26 weeks). Missing values due to withdrawal for reasons related to safety or efficacy were imputed using a baseline observation carried forward approach (BOCF).
Outcome measures
| Measure |
Experimental Arm A
n=209 Participants
Active treatment. Inhaled Mannitol
Inhaled mannitol: Inhaled mannitol 400 mg BD for 26 weeks
|
Arm B - Control
n=214 Participants
Arm B
Control BD (mannitol 50mg) for 26 weeks
|
|---|---|---|
|
Mean Change From Baseline FVC (mL) Over the 26-week Treatment Period
|
28 mL
Interval -14.0 to 70.0
|
-12 mL
Interval -53.0 to 29.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 26 weeksTo determine whether inhaled mannitol (400 mg b.i.d.) is superior to control in increasing the time to first protocol defined pulmonary exacerbation over the 26-week treatment period in adult subjects with CF. Protocol defined pulmonary exacerbations are those where 4 or more symptoms are recorded and are treated with IV antibiotics
Outcome measures
| Measure |
Experimental Arm A
n=209 Participants
Active treatment. Inhaled Mannitol
Inhaled mannitol: Inhaled mannitol 400 mg BD for 26 weeks
|
Arm B - Control
n=214 Participants
Arm B
Control BD (mannitol 50mg) for 26 weeks
|
|---|---|---|
|
Time to First Pulmonary Exacerbation Over the 26-week Treatment Period
|
NA days
Too few participants with protocol defined pulmonary exacerbations (PDPE), median time to first PDPE not reached
|
NA days
Too few participants with protocol defined pulmonary exacerbations (PDPE), median time to first PDPE not reached
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 26 weeksTo determine whether in adult subjects with CF, inhaled mannitol (400 mg b.i.d.) is superior to control for decreasing the number of days on antibiotics due to protocol defined pulmonary exacerbations. Overlapping antibiotics are counted separately.
Outcome measures
| Measure |
Experimental Arm A
n=209 Participants
Active treatment. Inhaled Mannitol
Inhaled mannitol: Inhaled mannitol 400 mg BD for 26 weeks
|
Arm B - Control
n=214 Participants
Arm B
Control BD (mannitol 50mg) for 26 weeks
|
|---|---|---|
|
Number of Days on Antibiotics (Oral, Inhaled or IV) Due to Pulmonary Exacerbation
|
8.1 days
Standard Deviation 31.25
|
5.5 days
Standard Deviation 17.94
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 26 weeksTo determine whether in adult subjects with CF, inhaled mannitol (400 mg b.i.d.) is superior to control for decreasing the number of days in hospital due to protocol defined pulmonary exacerbation.
Outcome measures
| Measure |
Experimental Arm A
n=209 Participants
Active treatment. Inhaled Mannitol
Inhaled mannitol: Inhaled mannitol 400 mg BD for 26 weeks
|
Arm B - Control
n=214 Participants
Arm B
Control BD (mannitol 50mg) for 26 weeks
|
|---|---|---|
|
Number of Days in Hospital Due to Pulmonary Exacerbation
0 days
|
192 Participants
|
199 Participants
|
|
Number of Days in Hospital Due to Pulmonary Exacerbation
1-7 days
|
1 Participants
|
4 Participants
|
|
Number of Days in Hospital Due to Pulmonary Exacerbation
8-14 days
|
4 Participants
|
6 Participants
|
|
Number of Days in Hospital Due to Pulmonary Exacerbation
15-21 days
|
5 Participants
|
3 Participants
|
|
Number of Days in Hospital Due to Pulmonary Exacerbation
22-28 days
|
3 Participants
|
2 Participants
|
|
Number of Days in Hospital Due to Pulmonary Exacerbation
>28 days
|
4 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 26 weeksTo determine whether inhaled mannitol (400 mg b.i.d.) decreases the rate of protocol defined pulmonary exacerbations over the 26-week treatment period compared to control in adult subjects with CF. Protocol defined pulmonary exacerbations defined by having 4 or more symptoms and treated with IV antibiotics.
Outcome measures
| Measure |
Experimental Arm A
n=209 Participants
Active treatment. Inhaled Mannitol
Inhaled mannitol: Inhaled mannitol 400 mg BD for 26 weeks
|
Arm B - Control
n=214 Participants
Arm B
Control BD (mannitol 50mg) for 26 weeks
|
|---|---|---|
|
Rate of Pulmonary Exacerbations Over the 26-week Treatment Period
0 protocol defined pulm exac
|
181 Participants
|
185 Participants
|
|
Rate of Pulmonary Exacerbations Over the 26-week Treatment Period
1 protocol defined pulm exac
|
24 Participants
|
29 Participants
|
|
Rate of Pulmonary Exacerbations Over the 26-week Treatment Period
2 protocol defined pulm exac
|
3 Participants
|
0 Participants
|
|
Rate of Pulmonary Exacerbations Over the 26-week Treatment Period
>2 protocol defined pulm exac
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 26 weeksTo determine whether in adult subjects with CF, inhaled mannitol (400 mg b.i.d.) is superior to control for decreasing incidence of protocol defined pulmonary exacerbations, where incidence is defined as the proportion of subjects with 1 or more exacerbation during the 26 week period.
Outcome measures
| Measure |
Experimental Arm A
n=209 Participants
Active treatment. Inhaled Mannitol
Inhaled mannitol: Inhaled mannitol 400 mg BD for 26 weeks
|
Arm B - Control
n=214 Participants
Arm B
Control BD (mannitol 50mg) for 26 weeks
|
|---|---|---|
|
The Incidence of Pulmonary Exacerbations
|
28 Participants
|
29 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 26 weeksTo determine whether in adult subjects with CF, inhaled mannitol (400 mg b.i.d.) is superior to control for improving ease of expectoration. The visual analogue scale (VAS) was 10cm. The position marked by the subject was converted into a score from 0 to 100 where 0 was the worst possible outcome and 100 was the best possible outcome. The VAS was completed at baseline, 6, 14 and 26 weeks. The mean absolute change from baseline over 26 weeks (ie the average of the changes at 6,14 and 26 weeks) is the outcome measure and will be compared between the two treatment groups with a REML based repeated measures approach. Least square means presented are for the change from baseline averaged over the treatment period (ie the average of the changes at 6 weeks, 14 weeks and 26 weeks). Missing values due to withdrawal for reasons related to safety or efficacy were imputed using a baseline observation carried forward approach (BOCF).
Outcome measures
| Measure |
Experimental Arm A
n=209 Participants
Active treatment. Inhaled Mannitol
Inhaled mannitol: Inhaled mannitol 400 mg BD for 26 weeks
|
Arm B - Control
n=214 Participants
Arm B
Control BD (mannitol 50mg) for 26 weeks
|
|---|---|---|
|
Mean Change From Baseline in Ease of Expectoration Measured Using a Visual Analogue Scale (VAS) Over 26 Weeks
|
0.795 cm
Interval 0.556 to 1.034
|
0.537 cm
Interval 0.306 to 0.767
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 26 weeksPopulation: Intent to Treat (ITT) - All patients randomised.
To determine whether in adult subjects with CF, inhaled mannitol (400 mg b.i.d.) is superior to control for improving respiratory symptoms measured by Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain. The CFQ-R respiratory domain score is a scale from 0 to 100. Higher scores are a more favourable response. The mean absolute change from baseline 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 change from baseline averaged over the treatment period (ie the average of the changes at 6 weeks, 14 weeks and 26 weeks). Missing values due to withdrawal for reasons related to safety or efficacy were imputed using a baseline observation carried forward approach (BOCF).
Outcome measures
| Measure |
Experimental Arm A
n=209 Participants
Active treatment. Inhaled Mannitol
Inhaled mannitol: Inhaled mannitol 400 mg BD for 26 weeks
|
Arm B - Control
n=214 Participants
Arm B
Control BD (mannitol 50mg) for 26 weeks
|
|---|---|---|
|
Change From Baseline Over 26 Weeks in CFQ-R Respiratory Domain Score
|
0.308 score on a scale
Interval -1.554 to 2.169
|
-0.562 score on a scale
Interval -2.357 to 1.234
|
POST_HOC outcome
Timeframe: 26 weeksThe mean absolute change from baseline FEF25-75 (mL/s) over weeks 6, 14 and 26 will be compared between the two treatment groups with a REML based repeated measures approach Least square means presented are for the change from baseline averaged over the treatment period (ie the average of the changes at 6 weeks, 14 weeks and 26 weeks). Missing values due to withdrawal for reasons related to safety or efficacy were imputed using a baseline observation carried forward approach (BOCF).
Outcome measures
| Measure |
Experimental Arm A
n=209 Participants
Active treatment. Inhaled Mannitol
Inhaled mannitol: Inhaled mannitol 400 mg BD for 26 weeks
|
Arm B - Control
n=214 Participants
Arm B
Control BD (mannitol 50mg) for 26 weeks
|
|---|---|---|
|
Absolute Change in Forced Expiratory Flow From 25% to 75% of Vital Capacity (FEF25-75) Over the 26-week Treatment Period.
|
109 mL/s
Interval 54.0 to 164.0
|
22 mL/s
Interval -32.0 to 75.0
|
Adverse Events
Experimental Arm A
Arm B - Control
Serious adverse events
| Measure |
Experimental Arm A
n=207 participants at risk
Active treatment. Inhaled Mannitol
Inhaled mannitol: Inhaled mannitol 400 mg BD for 26 weeks
Subjects randomised and treated.
|
Arm B - Control
n=213 participants at risk
Arm B
Control BD (mannitol 50mg) for 26 weeks
Subjects randomised and treated.
|
|---|---|---|
|
General disorders
Condition Aggravated
|
9.7%
20/207 • Number of events 25 • 26 weeks
|
7.0%
15/213 • Number of events 15 • 26 weeks
|
|
Infections and infestations
Lung Infection
|
0.48%
1/207 • Number of events 1 • 26 weeks
|
0.94%
2/213 • Number of events 2 • 26 weeks
|
|
Infections and infestations
Pneumonia
|
0.48%
1/207 • Number of events 1 • 26 weeks
|
0.94%
2/213 • Number of events 2 • 26 weeks
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/207 • 26 weeks
|
0.47%
1/213 • Number of events 1 • 26 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/207 • 26 weeks
|
0.47%
1/213 • Number of events 1 • 26 weeks
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.48%
1/207 • Number of events 1 • 26 weeks
|
0.00%
0/213 • 26 weeks
|
|
Infections and infestations
Lung infection pseudomonal
|
0.48%
1/207 • Number of events 1 • 26 weeks
|
0.00%
0/213 • 26 weeks
|
|
Infections and infestations
Meningitis bacterial
|
0.48%
1/207 • Number of events 1 • 26 weeks
|
0.00%
0/213 • 26 weeks
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/207 • 26 weeks
|
0.47%
1/213 • Number of events 1 • 26 weeks
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/207 • 26 weeks
|
0.47%
1/213 • Number of events 1 • 26 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/207 • 26 weeks
|
0.47%
1/213 • Number of events 1 • 26 weeks
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.48%
1/207 • Number of events 1 • 26 weeks
|
0.00%
0/213 • 26 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.48%
1/207 • Number of events 1 • 26 weeks
|
0.00%
0/213 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.48%
1/207 • Number of events 1 • 26 weeks
|
1.4%
3/213 • Number of events 3 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.48%
1/207 • Number of events 1 • 26 weeks
|
0.00%
0/213 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/207 • 26 weeks
|
0.47%
1/213 • Number of events 1 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/207 • 26 weeks
|
0.47%
1/213 • Number of events 1 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/207 • 26 weeks
|
0.47%
1/213 • Number of events 1 • 26 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.48%
1/207 • Number of events 1 • 26 weeks
|
0.94%
2/213 • Number of events 2 • 26 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.48%
1/207 • Number of events 1 • 26 weeks
|
0.47%
1/213 • Number of events 1 • 26 weeks
|
|
Gastrointestinal disorders
Distal intestinal obstruction syndrome
|
0.48%
1/207 • Number of events 1 • 26 weeks
|
0.00%
0/213 • 26 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/207 • 26 weeks
|
0.94%
2/213 • Number of events 2 • 26 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/207 • 26 weeks
|
0.47%
1/213 • Number of events 1 • 26 weeks
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/207 • 26 weeks
|
0.47%
1/213 • Number of events 1 • 26 weeks
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.48%
1/207 • Number of events 1 • 26 weeks
|
0.00%
0/213 • 26 weeks
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/207 • 26 weeks
|
0.47%
1/213 • Number of events 1 • 26 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.48%
1/207 • Number of events 1 • 26 weeks
|
0.00%
0/213 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/207 • 26 weeks
|
0.47%
1/213 • Number of events 1 • 26 weeks
|
Other adverse events
| Measure |
Experimental Arm A
n=207 participants at risk
Active treatment. Inhaled Mannitol
Inhaled mannitol: Inhaled mannitol 400 mg BD for 26 weeks
Subjects randomised and treated.
|
Arm B - Control
n=213 participants at risk
Arm B
Control BD (mannitol 50mg) for 26 weeks
Subjects randomised and treated.
|
|---|---|---|
|
General disorders
Condition Aggravated
|
27.1%
56/207 • Number of events 84 • 26 weeks
|
27.7%
59/213 • Number of events 75 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
23/207 • Number of events 25 • 26 weeks
|
9.9%
21/213 • Number of events 25 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
9.7%
20/207 • Number of events 27 • 26 weeks
|
9.4%
20/213 • Number of events 33 • 26 weeks
|
|
Nervous system disorders
Headache
|
5.8%
12/207 • Number of events 41 • 26 weeks
|
10.3%
22/213 • Number of events 47 • 26 weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.8%
14/207 • Number of events 17 • 26 weeks
|
5.2%
11/213 • Number of events 12 • 26 weeks
|
|
General disorders
Pyrexia
|
6.3%
13/207 • Number of events 18 • 26 weeks
|
3.8%
8/213 • Number of events 9 • 26 weeks
|
|
Infections and infestations
Nasopharyngitis
|
5.8%
12/207 • Number of events 17 • 26 weeks
|
4.7%
10/213 • Number of events 11 • 26 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place