lodinated Glycerol

Intention-to- Treat Analysis

A total of 367 patients were randomized (182 to iodinated glycerol and 185 to placebo) for inclusion in the intention-to-treat analysis; of these, six patients (two iodinated glycerol, and four placebo) did not meet the entry criteria and were discontinued from the study before treatment began. Therefore, a total of 361 patients (180 to iodinated glycerol and 181 to placebo) completed the baseline visit and were treated with either iodinated glycerol or placebo. There were 33 dropouts in the iodinated glycerol group (14 at week 4 and 19 at week 8) and 46 dropouts in the placebo group (26 at week 4 and 20 at week 8). Hence, the intention-to-treat analysis at week 8 included 147 patients in the iodinated glycerol group and 135 patients in the placebo group. The 33 dropouts in the iodinated glycerol group were attributed to voluntary withdrawals (15 patients), violation of protocol (three patients), exacerbations (five patients), and adverse experiences (ten patients). The 46 dropouts in the placebo group were attributed to voluntary withdraw­als (14 patients), violation of protocol (four patients), exacerbations (four patients), and adverse experiences (24 patients).

There were no statistically significant differences between the treatment groups for any demographic characteristics (Table 2). The forced expiratory mean FEVX was 43.6 percent of predicted value in the glycerol group and 45.5 percent of predicted value in the placebo group, indicating a study popu­lation with moderate-to-severe airway obstruction in both treatment groups that was equally non-respon­sive, ie, <5 percent increase in FEVb following a bronchodilator challenge. viagra soft

Primary Efficacy Parameters

Symptoms: The patient-derived global score im­proved significantly (p = 0.0048) for the iodinated glycerol group from 11.75 at baseline to 9.97 at week 8, as compared to placebo 12.05 at baseline and 10.89 at week 8 (Table 3).

Table 2—Demographics

Iodinated

Glycerol

Placebo

Characteristic

(N = 182)

(N = 185)

Age, in years
(range)

65 (32-82)

66 (29-83)

Sex, ratio of
male:female

70:30

73:27

Race,
%
of group

Caucasian

92

88

Black

5

7

Asian

3

5

Other

0

1

Duration of
bronchitis, in

12.1

11.8

years

FEV„
%
of predicted


Prebronchodilator

Mean (SD)

43.6 (17.06)

45.5 (18.21)

Range

9-99%

11-91%


Fostbronchodilator

Mean (SD)

47.9 (16.94)

50.3 (18.99)

Range

12-99%

11-91%

Baseline symptom
score

Mean (SE)

2.92 (0.047)

2.98 (0.051)

Concomitant
medications,

96

94

%
of group

Beta agonist

78

83

Steroids

32

28

Xanthines

68

66

Beta blocker

2

4

Ace inhibitors

4

8

The analysis of each symptom at week 8 showed similar significant results favoring iodinated glycerol for cough frequency, cough severity, chest discomfort, and mean score. Difficulty in breathing demonstrated a trend favoring iodinated glycerol.

Global evaluations: The patients’ assessment of ease in bringing up sputum and both the patients’ and physicians’ global assessment of the overall condition of the patient were evaluated at week 4 and week 8 (Table 4). The differences between the mean global ratings at week 4 and at week 8 within each group were compared across the iodinated glycerol and pla­cebo treatment groups. At week 8, the patients’ assess­ment of ease in bringing up sputum was significantly improved in the iodinated glycerol group as compared with the placebo group (p = 0.006). Likewise, the pa­tients’ assessment of their condition was significantly improved in the iodinated glycerol group as compared with the placebo group (p = 0.02). The physicians’ assessment of the condition of the patient did not show a statistically significant difference between the groups, even while the patients symptoms and global evaluation were showing significant improvement. levitra professional

Table 3—Mean Symptom Scores at Baseline and After Eight Weeks of Treatment with Iodinated Glycerol or Placebo

Iodinated
Clycerol

Placebo

Baseline

Week
8

Baseline

Week
8

Symptom

Mean

SE

Mean

SE

Mean

SE

Mean

SE

F-value*

Cough frequency

3.33

0.06

2.70

0.076

3.34

0.057

2.90

0.074

0.0300

Cough severity

2.99

0.06

2.51

0.079

3.02

0.068

2.69

0.072

0.0500

Chest discomfort

2.39

0.073

2.05

0.078

2.65

0.079

2.44

0.090

0.0008

Dyspnea

3.04

0.072

2.73

0.088

3.04

0.079

2.90

0.092

0.1000

Meant

2.94

0.047

2.55

0.060

2.99

0.051

2.76

0.060

0.0064

Derived global

11.75

0.189

9.97

0.248

12.05

0.204

10.89

0.252

0.0048

assessment

Secondary Efficacy Parameters

The mean duration (days) of acute exacerbations of chronic bronchitis between week 4 and week 8 was significantly less in the iodinated glycerol group (6.3, iodinated glycerol vs 10.2, placebo; p = 0.029, Student f-test), although there was no significant difference between the groups in the overall incidence of acute exacerbations of chronic bronchitis. There was no significant difference between treatment groups for frequency of aerosol bronchodilator use of for fre­quency of concomitant medications. However, the total number of dropouts favored the iodinated glycerol group over the placebo group (33, iodinated glycerol vs 46, placebo).
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Table 4 Comparison of Differences of Global Assessments Between Week 4 and Week 8

Iodinated
Glycerol

Placebo

Clobal
Assessment

W8-W4

SE

W8-W4

SE

P-value*

Ease in bringing
up sputum Patients’ assessment Physicians’ assessment

-0.054 -0.158
-0.048

0.126 0.120 0.123

+0.415 +0.185
+0.080

0.137 0.124 0.114

0.006

0.02

N.S.

Note: A negative
(—)
value denotes an improvement; a
positive
(+)
value denotes worsening. “Student
f-test for the differences between the iodinated glycerol group and
the placebo group.

Category: Diseases / Tags: lodinated Glycerol, Mucolytic Study, Obstructive Bronchitis, placebo-controlled study

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