Noninterventional Open-Label Trial Investigating the Efficacy and Safety of Ectoine Containing Nasal Spray in Comparison with Beclomethasone Nasal Spray in Patients with Allergic Rhinitis
Table 4
Results (changes from V1 to V2) of the quality of life questionnaire documented by physicians.
Group 1
Group 2
Total
Frequency of tissue use
Reduced
12 (48.0%)
15 (60.0%)
27 (54.0%)
Unchanged
11 (44.0%)
7 (28.0%)
18 (36.0%)
Increased
2 (8.0%)
3 (12.0%)
5 (10.0%)
Total
25 (100.0%)
25 (100.0%)
50 (100.0%)
Rubbing eyes and nose
Reduced
14 (56.0%)
14 (56.0%)
28 (56.0%)
Unchanged
8 (32.0%)
7 (28.0%)
15 (30.0%)
Increased
3 (12.0%)
4 (16.0%)
7 (14.0%)
Total
25 (100.0%)
25 (100.0%)
50 (100.0%)
Frequency of brushing of nose
Reduced
12 (48.0%)
21 (84.0%)
33 (66.0%)
Unchanged
8 (32.0%)
4 (16.0%)
12 (24.0%)
Increased
5 (20.0%)
0 (0.0%)
5 (10.0%)
Total
25 (100.0%)
25 (100.0%)
50 (100.0%)
Bad sleep
Reduced
15 (60.0%)
17 (68.0%)
32 (64.0%)
Unchanged
9 (36.0%)
7 (28.0%)
16 (32.0%)
Increased
1 (4.0%)
1 (4.0%)
2 (4.0%)
Gesamt
Total
25 (100.0%)
25 (100.0%)
50 (100.0%)
Bad work performance
Reduced
15 (60.0%)
20 (80.0%)
35 (70.0%)
Unchanged
7 (28.0%)
4 (16.0%)
11 (22.0%)
Increased
3 (12.0%)
1 (4.0%)
4 (8.0%)
Total
25 (100.0%)
25 (100.0%)
50 (100.0%)
Fatigue
Reduced
16 (64.0%)
15 (60.0%)
31 (62.0%)
Unchanged
8 (32.0%)
7 (28.0%)
15 (30.0%)
Increased
1 (4.0%)
3 (12.0%)
4 (8.0%)
Total
25 (100.0%)
25 (100.0%)
50 (100.0%)
Thirst
Reduced
10 (40.0%)
14 (56.0%)
24 (48.0%)
Unchanged
8 (32.0%)
9 (36.0%)
17 (34.0%)
Increased
7 (28.0%)
2 (8.0%)
9 (18.0%)
Total
25 (100.0%)
25 (100.0%)
50 (100.0%)
Lack of concentration
Reduced
10 (40.0%)
15 (60.0%)
25 (50.0%)
Unchanged
13 (52.0%)
8 (32.0%)
21 (42.0%)
Increased
2 (8.0%)
2 (8.0%)
4 (8.0%)
Total
25 (100.0%)
25 (100.0%)
50 (100.0%)
General well-being
Reduced
20 (80.0%)
16 (64.0%)
36 (72.0%)
Unchanged
4 (16.0%)
6 (24.0%)
10 (20.0%)
Increased
1 (4.0%)
3 (12.0%)
4 (8.0%)
Total
25 (100.0%)
25 (100.0%)
50 (100.0%)
Headache
Reduced
16 (64.0%)
10 (40.0%)
26 (52.0%)
Unchanged
8 (32.0%)
9 (36.0%)
17 (34.0%)
Increased
1 (4.0%)
6 (24.0%)
7 (14.0%)
Total
25 (100.0%)
25 (100.0%)
50 (100.0%)
Bad temper
Reduced
13 (52.0%)
17 (68.0%)
30 (60.0%)
Unchanged
8 (32.0%)
6 (24.0%)
14 (28.0%)
Increased
4 (16.0%)
2 (8.0%)
6 (12.0%)
Total
25 (100.0%)
25 (100.0%)
50 (100.0%)
General disconcertment
Reduced
12 (48.0%)
19 (76.0%)
31 (62.0%)
Unchanged
11 (44.0%)
6 (24.0%)
17 (34.0%)
Increased
2 (8.0%)
0 (0.0%)
2 (4.0%)
Total
25 (100.0%)
25 (100.0%)
50 (100.0%)
Frustration
Reduced
10 (40.0%)
16 (64.0%)
26 (52.0%)
Unchanged
14 (56.0%)
8 (32.0%)
22 (44.0%)
Increased
1 (4.0%)
1 (4.0%)
2 (4.0%)
Total
25 (100.0%)
25 (100.0%)
50 (100.0%)
Reactions of others to the allergy
Reduced
7 (28.0%)
10 (40.0%)
17 (34.0%)
Unchanged
18 (72.0%)
14 (56.0%)
32 (64.0%)
Increased
0 (0.0%)
1 (4.0%)
1 (2.0%)
Total
25 (100.0%)
25 (100.0%)
50 (100.0%)
In addition to the analysis described above, total decreases of scores of the quality of life questionnaires were analyzed. As depicted in Figure 5 and Figure 6, treatment resulted in decreases of all questioned parameters, thus indicating that all bothersome points which were covered in the questionnaire of life had improved during treatment.
