Determination of Responsive Groups Analyses

Patients with moderate-to-severe symptoms for all scores at baseline: A group of moderately-to-severely symptomatic patients (n=107) who had a baseline (visit 1) symptom score of 3, 4, or 5 for all assessment parameters (cough frequency, cough severity, chest discomfort, difficulty in breathing, and aerosol bron-chodilator use) was analyzed. The analysis of the primary efficacy parameters which included 41 patients in the iodinated glycerol group and 44 patients in the placebo group at week 8 showed results similar to the corresponding intention-to-treat analysis (Table 5). There were significant differences favoring the iodinated glycerol treatment group over the placebo group for cough frequency, chest discomfort, dyspnea, mean symptom scores, and patient derived evaluation after eight weeks of treatment.

Patients with moderate-to-severe individual symptoms at baseline; association with ease in bringing up sputum: An analysis was conducted to evaluate the response of the iodinated glycerol group vs the placebo group for ease in bringing up sputum and patients’ and physicians’ global evaluations when a particular baseline symptom was moderate to severe. This analysis compared differences between the mean global ratings of week 4 and at week 8 when an individual symptom parameter was assessed 3,4, or 5 at baseline.
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Table 5—Mean Scores for Moderate-to-Severe Symptoms at Baseline and After Eight Weeks of Treatment with Iodinated Glycerol or Placebo

Iodinated
Glycerol

Placebo

Baseline

Week
8

Baseline

Wfeek8

(N=50)

(N=41)

(N=57)

(N=44)

Symptom

Mean

SE

Mean

SE

Mean

SE

Mean

SE

F-value*

Cough frequency

3.78

0.071

2.90

0.129

3.75

0.076

3.36

0.130

0.0070

Cough severity

3.52

0.091

3.00

0.143

3.61

0.096

3.18

0.127

0.1733t

Chest discomfort

3.48

0.087

2.68

0.149

3.61

0.089

3.05

0.168

0.0561

Dyspnea

3.52

0.087

3.02

0.132

3.77

0.090

3.44

0.142

0.0175

Meant

3.62

0.055

3.02

0.107

3.74

0.062

3.32

0.102

0.0244

Derived global

14.30

0.232

11.60

0.468

14.74

0.261

12.98

0.434

0.0177

assessment

The patients’ assessment of ease in bringing up sputum and global evaluations of their condition were significantly improved in the iodinated glycerol group as compared with the placebo group in almost all cases when a particular baseline symptom score was assessed as moderate to severe (p<0.05). The physicians’ evaluations showed no significant differences between the groups for any moderate-to-severe baseline symptom score (Table 6).

Table 6—Differences in Mean Scores for Patient Assessments Between Week 4 and Week 8 Among Patients With a3, 4, or 5 Bating for each Baseline Symptom

Global
Assessment

Iodinated
Glycerol

Placebo

F-value

N

W8-W4

SE

N

W8-W4

SE

Cough Frequency

Ease in bringing
up sputum

118

-0.025

0.137

120

+0.408

0.151

0.017

Patients’ global

117

-0.068

0.130

120

+0.217

0.136

0.066

Cough Severity

Ease in bringing
up sputum

104

-0.077

0.165

102

+0.412

0.169

0.020

Patients’ global

103

-0.146

0.155

102

+0.275

0.152

0.028

Chest Discomfort

Ease in bringing
up sputum

59

+0.119

0.195

72

+0.486

0.193

0.090

Patients’ global

59

-0.136

0.200

72

+ 0.319

0.180

0.047

Dyspnea

Ease in bringing
up sputum

104

-0.019

0.158

93

+ 0.548

0.173

0.008

Patients’ global

103

-0.097

0.152

93

+0.290

0.157

0.039

“Maximally improving” responsive group: An analysis was carried out in the most severely symptomatic patients, ie, those patients with a 4 or 5 rating for individual symptoms at baseline who improved to a 1 (none) or 2 (mildly) symptomatic rating at week 8. At baseline, the number of patients with severe symptoms was similar for both groups: cough frequency (66, iodinated glycerol vs 61, placebo), cough severity (32, iodinated glycerol vs 35, placebo), chest discomfort (20, iodinated glycerol vs 30, placebo), and dyspnea (50, iodinated glycerol vs 53, placebo). The number of patients demonstrating improvement of individual symptoms in the iodinated glycerol group ranged from 24-50 percent, while the placebo group ranged from 11-20 percent. This improvement in the iodinated glycerol group was statistically significant (p<0.05) for chest discomfort and dyspnea, while a positive trend (p<0.1) was demonstrated for cough severity. canada pharmacy mall

Table 7—Mean Symptom Scores for Patients Taking Concomitant Corticosteroid Therapy

Iodinated
Glycerol

Placebo

(N = 62)

(N = 54)

(N = 56)

(N = 43)

Symptom

Baseline

SE

Week
8

SE

Baseline

SE

Week
8

SE

F-value*

Cough frequency

3.24

0.096

2.65

0.115

3.30

0.107

3.12

0.125

0.0036

Cough severity

3.05

0.087

2.56

0.123

3.00

0.116

2.95

0.148

0.0211

Chest discomfort

2.58

0.111

2.30

0.133

2.63

0.128

2.74

0.166

0.0195

Dyspnea

3.32

0.104

2.98

0.130

3.10

0.126

3.23

0.151

0.1067

Derived global
assessment

12.19

0.279

10.48

0.405

12.03

0.346

12.04

0.461

0.0062

Patients taking concomitant corticosteroid therapy: Mean symptom scores for patients taking concomitant corticosteroid therapy were compared for the two treatment groups (Table 7). Significant (p<0.05) symptom responses were observed in the iodinated glycerol group at week 8 for cough frequency, cough severity, chest discomfort, and the patients’ derived assessment (12.19 to 10.48, iodinated glycerol vs 12.03 to 12.04, placebo: p = 0.006). Also, in this subset of patients, the iodinated glycerol group had eight dropouts between baseline and week 8 and placebo group had 13 dropouts.

Table 8—Adverse Experiences by Body System in the Iodinated Glycerol and Placebo Groups

Iodinated

Glycerol

Placebo

Body System

(N=31)

(N = 36)

Gastrointestinal

12

26

Respiratory

7

9

Cardiac

6

3

Neurologic

8

5

Dermatologic

3

3

Lymphatic

2

Musculoskeletal

_L

_2

Total

39

48

Safety

Sixty^seven patients (31 iodinated glycerol and 36 placebo) in this study reported a total of 87 adverse experiences (table 8). The three patients in the iodi¬nated glycerol group with dermatologic adverse experiences had a non-iodoform rash, and the two patients in the iodinated glycerol group with lymphatic adverse experiences had generalized lymphadenopa- thy. There were more than twice as many gastrointestinal adverse experiences in the placebo group of which nausea comprised 35 percent. There were no endocrinologic adverse experiences reported. The difference between groups in the number of dropouts attributable to adversed experiences (ten, iodinated glycerol vs 24 placebo) favored the iodinated glycerol group. generic cialis 20mg

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

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