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Long Term Administration of Inhaled Mannitol in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT00630812
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : October 9, 2020
Last Update Posted : October 9, 2020
Sponsor:
Collaborators:
ethica Clinical Research Inc.
Europe: KasaConsult bvba, Hoegaarden, Belgium
Argentina: Resolution Latin America; Buenos Aires, Argentina
Information provided by (Responsible Party):
Pharmaxis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cystic Fibrosis
Interventions Drug: inhaled mannitol
Drug: Placebo comparator
Enrollment 318
Recruitment Details  
Pre-assignment Details 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)
Arm/Group Title Mannitol 400mg Control
Hide Arm/Group Description

active treatment

inhaled mannitol: 400 mg twice a day (BD) for 26 + 26 weeks

Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
Period Title: Randomisation to First Dose
Started 192 126
Completed 184 121
Not Completed 8 5
Reason Not Completed
Adverse Event             1             1
Withdrawal by Subject             2             3
Lost to Follow-up             1             0
Protocol Violation             4             1
Period Title: Double Blind Treatment Period
Started [1] 184 121
Completed 153 107
Not Completed 31 14
Reason Not Completed
Adverse Event             13             5
Lost to Follow-up             1             0
Physician Decision             2             1
Protocol Violation             1             0
Withdrawal by Subject             13             7
Wanted to take drug in non-protocol way             1             0
Non-compliance             0             1
[1]
Randomised and received first dose (mITT population). Patients not starting treatment are excluded
Arm/Group Title Mannitol 400mg Control Total
Hide Arm/Group Description

active treatment

inhaled mannitol: 400 mg BD for 26 + 26 weeks

Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase Total of all reporting groups
Overall Number of Baseline Participants 184 121 305
Hide Baseline Analysis Population Description
Randomised and Treated (mITT)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 184 participants 121 participants 305 participants
<=18 years
91
  49.5%
63
  52.1%
154
  50.5%
Between 18 and 65 years
93
  50.5%
58
  47.9%
151
  49.5%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 184 participants 121 participants 305 participants
Female
90
  48.9%
58
  47.9%
148
  48.5%
Male
94
  51.1%
63
  52.1%
157
  51.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 184 participants 121 participants 305 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   1.1%
2
   1.7%
4
   1.3%
White
182
  98.9%
119
  98.3%
301
  98.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 184 participants 121 participants 305 participants
Canada 11 9 20
Argentina 48 32 80
Netherlands 2 2 4
Belgium 10 6 16
United States 85 54 139
France 14 9 23
Germany 14 9 23
Hospitalisations in year prior to study participation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 184 participants 121 participants 305 participants
0 hospitalisations
114
  62.0%
76
  62.8%
190
  62.3%
1 hospitalisation
41
  22.3%
30
  24.8%
71
  23.3%
2 hospitalisations
21
  11.4%
9
   7.4%
30
   9.8%
3 hospitalisations
4
   2.2%
4
   3.3%
8
   2.6%
>3 hospitalisations
4
   2.2%
2
   1.7%
6
   2.0%
Pulmonary exacerbations in year prior to study participation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 184 participants 121 participants 305 participants
0 exacerbations
104
  56.5%
74
  61.2%
178
  58.4%
1 exacerbation
45
  24.5%
28
  23.1%
73
  23.9%
2 exacerbations
26
  14.1%
14
  11.6%
40
  13.1%
3 exacerbations
4
   2.2%
3
   2.5%
7
   2.3%
>3 exacerbations
5
   2.7%
2
   1.7%
7
   2.3%
CF mutation   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 184 participants 121 participants 305 participants
Both deltaF508
77
  41.8%
45
  37.2%
122
  40.0%
One deltaF508
57
  31.0%
52
  43.0%
109
  35.7%
At least one other known mutation
15
   8.2%
5
   4.1%
20
   6.6%
Both unknown
35
  19.0%
19
  15.7%
54
  17.7%
[1]
Measure Description: Cystic Fibrosis (CF) mutation
1.Primary Outcome
Title Change in Absolute FEV1 From Baseline Over 26 Weeks
Hide Description 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.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
mITT (modified intent to treat) - patients randomised and treated with at least one dose of study medication)
Arm/Group Title Mannitol 400mg Control
Hide Arm/Group Description:

active treatment

inhaled mannitol: 400 mg BD for 26 + 26 weeks

Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
Overall Number of Participants Analyzed 184 121
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mL
106.53
(62.43 to 150.62)
52.38
(2.09 to 102.68)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mannitol 400mg, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.059
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 54.14
Confidence Interval (2-Sided) 95%
-1.97 to 110.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mannitol 400mg, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments Response defined as change of >=100mL at week 26
Method Regression, Logistic
Comments 45.7% response on Mannitol 400mg, 35.5% on Control
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.69
Confidence Interval (2-Sided) 95%
1.02 to 2.80
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in FEV1 From Baseline Over 26 Weeks - Dornase Users
Hide Description

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

Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Note these are subset of dornase users - effect in dornase users was estimated using a model fitted using data from all patients
Arm/Group Title Mannitol 400mg Control
Hide Arm/Group Description:

active treatment

inhaled mannitol: 400 mg BD for 26 + 26 weeks

Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
Overall Number of Participants Analyzed 137 92
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mL
78.60
(27.64 to 129.56)
35.11
(-20.99 to 91.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mannitol 400mg, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.177
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 43.49
Confidence Interval (2-Sided) 95%
-19.8 to 106.78
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Rate of Protocol Defined Pulmonary Exacerbations (PDPE)
Hide Description 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.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
mITT (randomised and treated)
Arm/Group Title Mannitol 400mg Control
Hide Arm/Group Description:

active treatment

inhaled mannitol: 400 mg BD for 26 + 26 weeks

Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
Overall Number of Participants Analyzed 184 121
Measure Type: Count of Participants
Unit of Measure: Participants
With 1 PDPE
21
  11.4%
18
  14.9%
With 2 PDPE
6
   3.3%
4
   3.3%
With 3 PDPE
1
   0.5%
1
   0.8%
No PDPEs
156
  84.8%
98
  81.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mannitol 400mg, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.520
Comments [Not Specified]
Method Poisson regression
Comments Offset of the natural logarithm of follow-up time
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.51 to 1.41
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Hospitalisations Associated With Protocol Defined Pulmonary Exacerbations (PDPEs)
Hide Description The number of hospitalisations is summarised and then the rate per person is analysed.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mannitol 400mg Control
Hide Arm/Group Description:

active treatment

inhaled mannitol: 400 mg BD for 26 + 26 weeks

Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
Overall Number of Participants Analyzed 184 121
Measure Type: Count of Participants
Unit of Measure: Participants
0 hospitalisations
162
  88.0%
102
  84.3%
1 hospitalisation
18
   9.8%
14
  11.6%
2 hospitalisations
3
   1.6%
5
   4.1%
3 hospitalisations
1
   0.5%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mannitol 400mg, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.328
Comments [Not Specified]
Method Poisson regression
Comments Offset of the natural logarithm of follow-up time
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.42 to 1.33
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Antibiotic Use Associated With PDPEs
Hide Description Number of courses per person in the 26 week period is summarised and then the rate per person analysed.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mannitol 400mg Control
Hide Arm/Group Description:

active treatment

inhaled mannitol: 400 mg BD for 26 + 26 weeks

Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
Overall Number of Participants Analyzed 184 121
Measure Type: Count of Participants
Unit of Measure: Participants
0 courses
156
  84.8%
98
  81.0%
1 course
22
  12.0%
19
  15.7%
2 courses
5
   2.7%
2
   1.7%
3 courses
1
   0.5%
2
   1.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mannitol 400mg, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.368
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.69 to 1.15
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Absolute Change in FEV1 Percent Predicted at 26 Weeks
Hide Description Change from baseline at 26 weeks in FEV1 percent predicted with BOCF for those with missing values at week 26
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Baseline Observation carried forward (BOCF) implemented for those with missing values at visit 4
Arm/Group Title Mannitol 400mg Control
Hide Arm/Group Description:

active treatment

inhaled mannitol: 400 mg BD for 26 + 26 weeks

Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
Overall Number of Participants Analyzed 184 121
Least Squares Mean (95% Confidence Interval)
Unit of Measure: % of predicted
3.14
(1.49 to 4.78)
0.72
(-1.18 to 2.62)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mannitol 400mg, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.42
Confidence Interval (2-Sided) 95%
0.33 to 4.51
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in FVC (mL) Across 26 Weeks
Hide Description Change from baseline in forced vital capacity (FVC) across 26 weeks (measured at 6,14 and 26 weeks)
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mannitol 400mg Control
Hide Arm/Group Description:

active treatment

inhaled mannitol: 400 mg BD for 26 + 26 weeks

Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
Overall Number of Participants Analyzed 184 121
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mL
136.33
(88.54 to 184.11)
64.98
(10.58 to 119.37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mannitol 400mg, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 71.35
Confidence Interval (2-Sided) 95%
10.57 to 132.13
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline FEF25-75 (mL/s) Over 26 Weeks
Hide Description Change 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.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mannitol 400mg Control
Hide Arm/Group Description:

active treatment

inhaled mannitol: 400 mg BD for 26 + 26 weeks

Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
Overall Number of Participants Analyzed 184 121
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mL/s
84.65
(6.66 to 162.63)
50.31
(-38.24 to 138.86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mannitol 400mg, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 34.34
Confidence Interval (2-Sided) 95%
-63.47 to 132.14
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Sputum Weight at Baseline in Response to First Dose of Treatment
Hide Description Sputum was collected during and for 30 minutes following the administration of the first dose of study treatment.
Time Frame up to 30 mins after first dose of trial treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Patients randomised and treated who have sputum weight results available.
Arm/Group Title Mannitol 400mg Control
Hide Arm/Group Description:

active treatment

inhaled mannitol: 400 mg BD for 26 + 26 weeks

Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
Overall Number of Participants Analyzed 180 114
Mean (Standard Deviation)
Unit of Measure: g
4.9  (6.18) 3.5  (4.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mannitol 400mg, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 26 weeks
Adverse Event Reporting Description Safety information reported is for the 26 week double blind period only
 
Arm/Group Title Mannitol 400mg Control
Hide Arm/Group Description

active treatment

inhaled mannitol: 400 mg BD for 26 + 26 weeks

Control (40mg inhaled mannitol) : BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
All-Cause Mortality
Mannitol 400mg Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/184 (0.00%)   1/121 (0.83%) 
Hide Serious Adverse Events
Mannitol 400mg Control
Affected / at Risk (%) Affected / at Risk (%)
Total   31/184 (16.85%)   30/121 (24.79%) 
Gastrointestinal disorders     
Pancreatitis * 1  1/184 (0.54%)  0/121 (0.00%) 
Distal intestinal obstruction syndrome * 1  0/184 (0.00%)  1/121 (0.83%) 
Intestinal obstruction * 1  0/184 (0.00%)  1/121 (0.83%) 
Pancreatis acute * 1  0/184 (0.00%)  1/121 (0.83%) 
Vomiting * 1  0/184 (0.00%)  1/121 (0.83%) 
General disorders     
Condition Aggravated * 1 [1]  27/184 (14.67%)  20/121 (16.53%) 
Hepatobiliary disorders     
Cholecystitis * 1  1/184 (0.54%)  0/121 (0.00%) 
Infections and infestations     
Bronchopneumonia * 1  1/184 (0.54%)  0/121 (0.00%) 
Lower respiratory tract infection * 1  0/184 (0.00%)  3/121 (2.48%) 
Acute tonsillitis * 1  0/184 (0.00%)  1/121 (0.83%) 
Appendicitis * 1  0/184 (0.00%)  1/121 (0.83%) 
Pneumonia * 1  0/184 (0.00%)  1/121 (0.83%) 
Pneumonia bacterial * 1  0/184 (0.00%)  1/121 (0.83%) 
Pyelonephritis * 1  0/184 (0.00%)  1/121 (0.83%) 
Metabolism and nutrition disorders     
Diabetes mellitus * 1  1/184 (0.54%)  0/121 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Haemoptysis * 1  2/184 (1.09%)  0/121 (0.00%) 
Asthmatic Crisis * 1  0/184 (0.00%)  1/121 (0.83%) 
Pleuritic Pain * 1  0/184 (0.00%)  1/121 (0.83%) 
Pneumothorax * 1  0/184 (0.00%)  1/121 (0.83%) 
1
Term from vocabulary, MedDRA (11.0)
*
Indicates events were collected by non-systematic assessment
[1]
pulmonary exacerbations were coded to condition aggravated
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mannitol 400mg Control
Affected / at Risk (%) Affected / at Risk (%)
Total   165/184 (89.67%)   106/121 (87.60%) 
Gastrointestinal disorders     
Abdominal pain * 1  14/184 (7.61%)  8/121 (6.61%) 
Abdominal pain upper * 1  6/184 (3.26%)  7/121 (5.79%) 
General disorders     
Condition Aggravated * 1 [1]  57/184 (30.98%)  41/121 (33.88%) 
Pyrexia * 1  17/184 (9.24%)  13/121 (10.74%) 
Infections and infestations     
Nasopharyngitis * 1  11/184 (5.98%)  6/121 (4.96%) 
Upper respiratory tract infection * 1  10/184 (5.43%)  11/121 (9.09%) 
Sinusitis * 1  8/184 (4.35%)  7/121 (5.79%) 
Nervous system disorders     
Headache * 1  26/184 (14.13%)  22/121 (18.18%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  28/184 (15.22%)  16/121 (13.22%) 
Pharyngolaryngeal pain * 1  19/184 (10.33%)  13/121 (10.74%) 
Haemoptysis * 1  11/184 (5.98%)  3/121 (2.48%) 
1
Term from vocabulary, MedDRA (11.0)
*
Indicates events were collected by non-systematic assessment
[1]
Pulmonary Exacerbations were coded to condition aggravated
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Brett Charlton
Organization: Pharmaxis
Phone: 02 94547210
EMail: Brett.Charlton@pharmaxis.com.au
Publications:
Layout table for additonal information
Responsible Party: Pharmaxis
ClinicalTrials.gov Identifier: NCT00630812    
Other Study ID Numbers: DPM-CF-302
First Submitted: February 27, 2008
First Posted: March 7, 2008
Results First Submitted: August 11, 2020
Results First Posted: October 9, 2020
Last Update Posted: October 9, 2020