Carrageenan-Containing Nasal Spray Alleviates Allergic Symptoms in Participants with Grass Pollen Allergy: A Randomized, Controlled, Crossover Clinical Trial

Figures & data

Figure 1 Patient disposition: Among the 5 patients who were not randomized, 3 failed to respond to the allergen challenge on screening and 2 were lost to follow-up. Randomized participants were assigned to one of six possible treatment sequences.

Abbreviations: IP, investigational product; CP, comparator product.

Table 1 Demographic and Clinical Characteristics of the Patients at Baseline (Intention-to-Treat Population)

	All Patients (n=42)
Sex:
Male	16 (38%)
Female	26 (62%)
Ethnicity:
Caucasian	42 (100%)
Age (years)	36 (22–62)
BMI (kg/m2)	24 (19–30)
Grass pollen allergy:
TNSS score in treatment period 1 - at baseline	0.14 ± 0.42
TNSS score in treatment period 2 - at baseline	0.12 ± 0.40
TNSS score in treatment period 3 - at baseline	0.12 ± 0.40

Abbreviations: BMI, body mass index; TNSS, total nasal symptom score.

Figure 2 Average time course of TNSS following allergen exposure for the three treatment periods. Error bars indicate SEM.

Abbreviations: TNSS, total nasal symptom score; SEM standard error of mean; IP, investigational product; CP, comparator product.

Table 2 Mean TNSS, its Individual Nasal Symptoms, and Nasal Secretion Weight at 3 hr. Difference from “No Treatment” Control is Given as Mean Treatment Difference with Associated 95% CIs and P-values

	No Treatment (Mean±SD)	IP (Mean±SD)	Mean Difference	95% CI	P-value of Wilcoxon Test
TNSS	8.286±2.635	7.690±2.561	0.595	−0.097, 1.287	0.028
Itchy nose	2.071±0.838	2.000±0.883	0.071	−0.239, 0.382	0.520
Nasal congestion	2.452±0.705	2.286±0.673	0.167	−0.014, 0.348	0.076
Rhinorrhea	2.095±0.850	1.833±0.853	0.262	0.067, 0.457	0.013
Sneezing	1.667±0.928	1.571±0.941	0.095	−0.178, 0.369	0.387
Nasal secretion (g)	2.535±3.020	2.144±2.062	0.391	−0.139, 0.920	0.218

Abbreviations: CI, confidence interval; IP, investigational product.

Table 3 Population Analysis of TNSS Scores

	Median		25%-Percentile		75%-Percentile
	No Treatment	IP	No Treatment	IP	No Treatment	IP
TNSS	8.5	8.0	7.0	7.0	10.0	9.0
Itchy nose	2.0	2.0	2.0	2.0	3.0	3.0
Nasalcongestion	3.0	2.0	2.0	2.0	3.0	3.0
Rhinorrhea	2.0	2.0	2.0	1.0	3.0	2.0
Sneezing	2.0	1.5	1.0	1.0	2.0	2.0

Abbreviations: TNSS, total nasal symptom score; IP, investigational product.

Table 4 Mean Nasal Secretion [G] Ø(0:30–3h) for the Full Analysis Set (FAS)

	IP	No Treatment	No Treatment - IP
Mean	2.48	2.85	0.37
SD	2.14	2.63	1.50
L.Quartile	0.83	1.18	−0.48
U.Quartile	3.71	3.72	0.92
Min	0.00	0.05	−2.72
Max	7.71	11.98	4.63
N	42	42	42

Notes: Mean nasal secretion [g]. FAS population. The mean difference of No Treatment - IP = 0.37, 95% CI [−0.10; 0.84], p = 0.119 (Paired t-test).

Table 5 Safety Profile. All Adverse Events Started During a Washout Phase and Were Rated as Non-Related to the Treatment

SOC	PT	All
		Mild	Moderate	Severe	Total
Gastrointestinal disorders		0	1	0	1
	Toothache	0	1	0	1
Injury, poisoning and procedural complications		0	0	1	1
	Keratorhexis	0	0	1	1
Musculoskeletal and connective tissue disorders		0	0	1	1
	Pain in jaw	0	0	1	1
Nervous system disorders		0	4	0	4
	Headache	0	3	0	3
	Migraine	0	1	0	1
Reproductive system and breast disorders		0	1	0	1
	Dysmenorrhoea	0	1	0	1
Respiratory, thoracic and mediastinal disorders		0	2	0	2
	Oropharyngeal pain	0	1	0	1
	Rhinorrhoea	0	1	0	1
Surgical and medical procedures		0	0	1	1
	Dental operation	0	0	1	1
Total		0	8	3	11

Notes: Adverse events grouped by System Organ Class (SOC), preferred term (PT) and severity; Safety set.