Clinical impact of nasal budesonide treatment on COPD patients with coexistent rhinitis

Figures & data

Table 1 Baseline characteristics

Variables
Age, mean±SD	64.7±9.4
Male, n (%)	35 (71.4)
Smokers
Current, n (%)	27 (55.1)
Former, n (%)	22 (44.9)
Exacerbations ≥2/previous year
Yes, n (%)	33 (67.4)
No, n (%)	16 (32.6)
Comorbidity
Cardiovascular diseases, n (%)	17 (34.7)
Diabetes, n (%)	3 (6.1)
OSAS, n (%)	3 (6.1)
GOLD spirometry grade, n (%)
1. Mild	5 (10.2)
2. Moderate	30 (61.2)
3. Severe	12 (24.5)
4. Very severe	2 (4.1)
GOLD groups, n (%)
A	3 (6)
B	11 (22.5)
C	10 (20.5)
D	25 (51)
COPD therapy, n (%)
LAMA	12 (24.5)
LABA/ICS	4 (8)
LAMA/LABA	9 (18.5)
LAMA/LABA/ICS	24 (49)
Allergy, n (%)
Yes	11 (22.5)
No	38 (77.5)
Nasal endoscopy, n (%)
Turbinates hypertrophy	13 (26.5)
Nasal discharge	32 (65.3)
Nasal hyperemia	20 (40.8)

Abbreviations: GOLD, Global initiative for chronic Obstructive Lung Disease; ICS, inhaled corticosteroid; LABA, long-acting beta 2 agonists; LAMA, long-acting muscarinic antagonists; OSAS, obstructive sleep apnea.

Table 2 CAT, SNOT 22, mMRC score, and spirometric variables at baseline and at the end of the study

Variables	Pre-nasal budesonide	Post-nasal budesonide	p-value
CAT total score	15 (11–21)	8 (5–12)	<0.001
SNOT 22 total score	24 (15–32)	10 (7–15)	<0.001
SNOT rhino/ear–facial score	19 (11–25)	9 (6–12)	<0.001
mMRC total score	2 (1–2)	1 (0–2)	<0.001
Spirometry
FEV1 (L) pre-bd	1.49 (1.05–2.1)	1.41 (1.1–2.1)	0.78
FEV1 (%) pre-bd	58 (51–72)	61 (52–74)	0.22
FVC1 (L) pre-bd	2.69 (1.9–3.6)	2.68 (2.2–3.4)	0.39
FVC1 (%) pre-bd	86 (72–95)	87 (74–97)	0.13
FEV1/FVC (%), mean (SD)	58.6 (1.2)	57.7 (1.1)	0.42

Notes: Data distribution is described as median and IQR, except when specified. Wilcoxon matched-pairs signed-ranks test was used. Paired t-test was used for FEV₁/FVC % differences.

Abbreviations: CAT, COPD assessment test; FEV₁, forced expiratory volume in 1 second; FVC, forced vital capacity; IQR, interquartile range; mMRC, modified Medical Research Council; pre-bd, pre-bronchodilator; SNOT 22, Sinonasal Outcome Test.

Figure 1 Graphs represent differences, controlled by score at enrollment, in CAT, SNOT 22, and mMRC questionnaires among subgroups according to allergy, history of exacerbations, smoking status, spirometry stage, GOLD stage, and ICS therapy.

Note: Each point represents mean difference with the bar at 95% CI.
Abbreviations: CAT, COPD assessment test; GOLD, Global initiative for chronic Obstructive Lung Disease; ICS, inhaled corticosteroid; mMRC, modified Medical Research Council; SNOT 22, Sinonasal Outcome Test.

Table 3 Percentage of score ≥1 and ≥4 for each item of CAT

CAT	% score ≥1			% score ≥4
Questions (n)	Pre-nasal budesonide, %	Post-nasal budesonide, %	p-value	Pre-nasal budesonide, %	Post-nasal budesonide, %	p-value
1. Cough	86	61	0.004	41	14	0.001
2. Mucus in the chest	80	57	0.003	37	6	0.0003
3. Chest tightness	55	39	0.04	16	4	0.07
4. Breathless when walking	98	86	0.07	45	14	0.003
5. Limited doing activities	76	61	0.065	27	10	0.02
6. Confident living home	55	20	0.001	8	2	0.38
7. Do not sleep soundly	51	24	0.004	12	4	0.22
8. No energy	67	65	.0.99	10	6	0.69

Note: p-value are calculated using McNemar’s test.

Abbreviation: CAT, COPD assessment test.

Table 4 Percentage of score ≥1 and ≥4 for each item of SNOT 22 nose, ear, and facial subdomains

SNOT 22	% score ≥1			% score ≥4
Questions (n)	Pre-nasal budesonide, %	Post-nasal budesonide, %	p-value	Pre-nasal budesonide, %	Post-nasal budesonide, %	p-value
1. Need to blow nose	71	55	0.08	31	6	0.004
2. Sneezing	76	51	0.002	12	4	0.13
3. Runny nose	61	31	0.002	16	0	0.008
4. Nasal obstruction	73	45	0.003	27	6	0.006
5. Loss of smell or taste	43	31	0.18	18	4	0.04
6. Cough	80	57	0.02	29	10	0.035
7. Post-nasal discharge	84	55	0.003	31	2	0.0001
8. Thick nasal discharge	61	41	0.05	14	0	0.016
9. Ear fullness	43	43	>0.99	12	4	0.22
10. Dizziness	43	31	0.21	8	2	0.38
11. Ear pain	14	12	>0.99	0	0	>0.99
12. Facial pain/pressure	43	31	0.18	18	0	0.004

Note: p-values are calculated using McNemar’s test.

Abbreviation: SNOT 22, Sinonasal Outcome Test.

Figure 2 Scatter plots representing FEV₁ values, CAT, and SNOT 22 questionnaire scores at enrollment (visit 0) and after therapy (delta, difference between visit 2 and visit 0). Spearman’s rank correlation test was used to determine the relationships between axis.

Note: CAT and SNOT 22 correlation (A, B); FEV₁ and SNOT 22 correlation (C, D).
Abbreviations: CAT, COPD assessment test; FEV₁, forced expiratory volume in 1 second; SNOT 22, Sinonasal Outcome Test.