Trial Outcomes & Findings for Testing the Efficacy in Adults With Cold of HEalsea Rescue* (NCT NCT05819190)
NCT ID: NCT05819190
Last Updated: 2024-10-08
Results Overview
The WURSS-21 questionnaire scores the severity and functional impact of a cold (items 2 to 11 and 12 to 20 respectively) plus 2 items for global severity and global change (items 1 and 21 respectively). Each item is scored from 0 (not sick / Do not have this symptom / Not at all / Very much better) to 7 (severely, severe, severely, very much worse) for global assessment, symptoms, functional impairment and global change respectively. The question 21 is not included in the calculation of the total score of the WURSS-21. The minimum WURSS-21 score is zero (0) and the maximum WURSS-21 score is one hundred forty (140). The questionnaire was completed in a diary once daily in the evening, taking into account the symptoms from the morning to the evening, during Day 2-Day 8 (day of the end of treatment). At Day 1, the WURSS-21 was completed during the visit. After Day 8, it was assessed once daily until the subject feels not sick for two consecutive days.
COMPLETED
NA
200 participants
Treatment period, from Day 1 to Day 8
2024-10-08
Participant Flow
First patient first visit: 14th December 2022 Last patient last visit: 31 th January 2023 Location: Bulgaria, 1 site
Participant milestones
| Measure |
Healsea Rescue* Group
Subjects will receive Healsea Rescue\* according to its intended use.
Healsea Rescue\*: Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
Placebo Group
Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.
Placebo: Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
100
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Healsea Rescue* Group
n=100 Participants
Subjects will receive Healsea Rescue\* according to its intended use.
Healsea Rescue\*: Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
Placebo Group
n=100 Participants
Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.
Placebo: Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.1 Years
STANDARD_DEVIATION 14.0 • n=100 Participants
|
34.4 Years
STANDARD_DEVIATION 13.4 • n=100 Participants
|
35.3 Years
STANDARD_DEVIATION 13.7 • n=200 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=100 Participants
|
54 Participants
n=100 Participants
|
111 Participants
n=200 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=100 Participants
|
46 Participants
n=100 Participants
|
89 Participants
n=200 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Bulgaria
|
100 participants
n=100 Participants
|
100 participants
n=100 Participants
|
200 participants
n=200 Participants
|
|
Total WURSS-21 score at baseline
|
37.7 units on a scale
STANDARD_DEVIATION 20.1 • n=100 Participants
|
37.0 units on a scale
STANDARD_DEVIATION 18.2 • n=100 Participants
|
37.4 units on a scale
STANDARD_DEVIATION 19.1 • n=200 Participants
|
PRIMARY outcome
Timeframe: Treatment period, from Day 1 to Day 8Population: Full Analysis Set (FAS)
The WURSS-21 questionnaire scores the severity and functional impact of a cold (items 2 to 11 and 12 to 20 respectively) plus 2 items for global severity and global change (items 1 and 21 respectively). Each item is scored from 0 (not sick / Do not have this symptom / Not at all / Very much better) to 7 (severely, severe, severely, very much worse) for global assessment, symptoms, functional impairment and global change respectively. The question 21 is not included in the calculation of the total score of the WURSS-21. The minimum WURSS-21 score is zero (0) and the maximum WURSS-21 score is one hundred forty (140). The questionnaire was completed in a diary once daily in the evening, taking into account the symptoms from the morning to the evening, during Day 2-Day 8 (day of the end of treatment). At Day 1, the WURSS-21 was completed during the visit. After Day 8, it was assessed once daily until the subject feels not sick for two consecutive days.
Outcome measures
| Measure |
Healsea Rescue* Group
n=100 Participants
Subjects will receive Healsea Rescue\* according to its intended use.
Healsea Rescue\*: Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
Placebo Group
n=100 Participants
Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.
Placebo: Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
|---|---|---|
|
AUC (Area Under Curve) of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) During First 8 Days of Symptoms as Compared Between Both Groups - Full Analysis Set (FAS)
|
135.60 Score on a scale*day
Standard Deviation 89.88
|
177.77 Score on a scale*day
Standard Deviation 125.40
|
PRIMARY outcome
Timeframe: Treatment period, from Day 1 to Day 8Population: Per Protocol Set (PP)
The WURSS-21 questionnaire scores the severity and functional impact of a cold (items 2 to 11 and 12 to 20 respectively) plus 2 items for global severity and global change (items 1 and 21 respectively). Each item is scored from 0 (not sick / Do not have this symptom / Not at all / Very much better) to 7 (severely, severe, severely, very much worse) for global assessment, symptoms, functional impairment and global change respectively. The question 21 is not included in the calulation of the total score of the WURSS-21. The minimum WURSS-21 score is zero (0) and the maximum WURSS-21 score is one hundred forty (140). The questionnaire was completed in a diary once daily in the evening, taking into account the symptoms from the morning to the evening, during Day 2-Day 8 (day of the end of treatment). At Day 1, the WURSS-21 was completed during the visit. After Day 8, it was assessed once daily until the subject feels not sick for two consecutive days.
Outcome measures
| Measure |
Healsea Rescue* Group
n=58 Participants
Subjects will receive Healsea Rescue\* according to its intended use.
Healsea Rescue\*: Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
Placebo Group
n=68 Participants
Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.
Placebo: Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
|---|---|---|
|
AUC (Area Under Curve) of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) During First 8 Days of Symptoms as Compared Between Both Groups - Per Protocol Set (PP)
|
122.50 score on a scale*day
Standard Deviation 83.42
|
163.21 score on a scale*day
Standard Deviation 114.00
|
SECONDARY outcome
Timeframe: Treatment period, from Day 1 to Day 8Population: Full Analysis Set (FAS)
The Symptoms' WURSS-21 questionnaire scores the severity of the cold (items 2 to 11). Each item is scored from 0 (Do not have this symptom) to 7 (Severe). The minimum Symptoms' WURSS-21 score is zero (0) and the maximum is seventy (70). The questionnaire was completed in a diary once daily in the evening, taking into account the symptoms from the morning to the evening, during Day 2-Day 8 (day of the end of treatment). At Day 1, the Symptoms' WURSS-21 was completed during the visit. After Day 8, it was assessed once daily until the subject feels not sick for two consecutive days.
Outcome measures
| Measure |
Healsea Rescue* Group
n=100 Participants
Subjects will receive Healsea Rescue\* according to its intended use.
Healsea Rescue\*: Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
Placebo Group
n=100 Participants
Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.
Placebo: Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
|---|---|---|
|
AUC of the Symptoms Sub-score (Items 2-11) of the WURSS-21 During First 8 Days
|
67.11 score on a sub-scale*day
Standard Deviation 43.09
|
87.57 score on a sub-scale*day
Standard Deviation 53.15
|
SECONDARY outcome
Timeframe: Treatment period, from Day 1 to Day 8Population: Full Analysis Set (FAS)
The Quality-of-Life' WURSS-21 questionnaire scores the impact of the cold on quality of life (items 12 to 20). Each item is scored from 0 (Not at all) to 7 (Severely). The minimum Quality-of-Life' WURSS-21 score is zero (0) and the maximum is sixty three (63). The questionnaire was completed in a diary once daily in the evening, taking into account the symptoms from the morning to the evening, during Day 2-Day 8 (day of the end of treatment). At Day 1, the Symptoms' WURSS-21 was completed during the visit. After Day 8, it was assessed once daily until the subject feels not sick for two consecutive days
Outcome measures
| Measure |
Healsea Rescue* Group
n=100 Participants
Subjects will receive Healsea Rescue\* according to its intended use.
Healsea Rescue\*: Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
Placebo Group
n=100 Participants
Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.
Placebo: Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
|---|---|---|
|
AUC of the Quality of Life Sub-score (Items 12-20) of the WURSS-21 During First 8 Days
|
54.36 score on a sub-scale*day
Standard Deviation 59.49
|
74.50 score on a sub-scale*day
Standard Deviation 79.15
|
SECONDARY outcome
Timeframe: Through study completion, up to Day 15Population: Full Analysis Set
For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days.
Outcome measures
| Measure |
Healsea Rescue* Group
n=100 Participants
Subjects will receive Healsea Rescue\* according to its intended use.
Healsea Rescue\*: Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
Placebo Group
n=100 Participants
Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.
Placebo: Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
|---|---|---|
|
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Runny Nose
|
6.1 days
Standard Deviation 3.1
|
7.2 days
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Through study completion, up to Day 15Population: Full Analysis Set
For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days.
Outcome measures
| Measure |
Healsea Rescue* Group
n=100 Participants
Subjects will receive Healsea Rescue\* according to its intended use.
Healsea Rescue\*: Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
Placebo Group
n=100 Participants
Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.
Placebo: Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
|---|---|---|
|
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Plugged Nose
|
5.9 days
Standard Deviation 3.1
|
6.9 days
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Through study completion, up to Day 15Population: Full Analysis Set
For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days.
Outcome measures
| Measure |
Healsea Rescue* Group
n=100 Participants
Subjects will receive Healsea Rescue\* according to its intended use.
Healsea Rescue\*: Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
Placebo Group
n=100 Participants
Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.
Placebo: Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
|---|---|---|
|
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sneezing
|
3.3 days
Standard Deviation 3.4
|
4.3 days
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Through study completion, up to Day 15Population: Full Analysis Set
For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days.
Outcome measures
| Measure |
Healsea Rescue* Group
n=100 Participants
Subjects will receive Healsea Rescue\* according to its intended use.
Healsea Rescue\*: Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
Placebo Group
n=100 Participants
Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.
Placebo: Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
|---|---|---|
|
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sore Throat
|
3.9 days
Standard Deviation 3.7
|
3.9 days
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Through study completion, up to Day 15Population: Full Analysis Set
For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days.
Outcome measures
| Measure |
Healsea Rescue* Group
n=100 Participants
Subjects will receive Healsea Rescue\* according to its intended use.
Healsea Rescue\*: Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
Placebo Group
n=100 Participants
Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.
Placebo: Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
|---|---|---|
|
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Cough
|
4.2 days
Standard Deviation 4.3
|
4.3 days
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Through study completion, up to Day 15Population: Full Analysis Set
For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days.
Outcome measures
| Measure |
Healsea Rescue* Group
n=100 Participants
Subjects will receive Healsea Rescue\* according to its intended use.
Healsea Rescue\*: Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
Placebo Group
n=100 Participants
Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.
Placebo: Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
|---|---|---|
|
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Scratchy Throat
|
4.5 days
Standard Deviation 3.9
|
4.3 days
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Through study completion, up to Day 15Population: Full Analysis Set
For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days.
Outcome measures
| Measure |
Healsea Rescue* Group
n=100 Participants
Subjects will receive Healsea Rescue\* according to its intended use.
Healsea Rescue\*: Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
Placebo Group
n=100 Participants
Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.
Placebo: Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
|---|---|---|
|
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Hoarseness
|
3.7 days
Standard Deviation 3.9
|
3.9 days
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Through study completion, up to Day 15Population: Full Analysis Set
For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days.
Outcome measures
| Measure |
Healsea Rescue* Group
n=100 Participants
Subjects will receive Healsea Rescue\* according to its intended use.
Healsea Rescue\*: Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
Placebo Group
n=100 Participants
Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.
Placebo: Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
|---|---|---|
|
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Head Congestion
|
4.7 days
Standard Deviation 4.2
|
3.9 days
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Through study completion, up to Day 15Population: Full Analysis Set
For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days.
Outcome measures
| Measure |
Healsea Rescue* Group
n=100 Participants
Subjects will receive Healsea Rescue\* according to its intended use.
Healsea Rescue\*: Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
Placebo Group
n=100 Participants
Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.
Placebo: Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
|---|---|---|
|
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Chest Congestion
|
3.1 days
Standard Deviation 3.8
|
3.2 days
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Through study completion, up to Day 15Population: Full Analysis Set
For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days.
Outcome measures
| Measure |
Healsea Rescue* Group
n=100 Participants
Subjects will receive Healsea Rescue\* according to its intended use.
Healsea Rescue\*: Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
Placebo Group
n=100 Participants
Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.
Placebo: Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
|---|---|---|
|
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Feeling Tired
|
4.7 days
Standard Deviation 3.9
|
4.4 days
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Through study completion, up to Day 15Population: Full Analysis set
Concomitant treatments (antipyretics, systemic or local mucolytics, decongestants, antitussives, antibiotics) use will be reported in the e-diary by the patient throughout the study, validated by the investigator at the end of study visit before being reported in the e-CRF.
Outcome measures
| Measure |
Healsea Rescue* Group
n=100 Participants
Subjects will receive Healsea Rescue\* according to its intended use.
Healsea Rescue\*: Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
Placebo Group
n=100 Participants
Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.
Placebo: Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
|---|---|---|
|
Cumulative Number of Days of Usual Medication for Common Cold Use
|
7 days
|
15 days
|
SECONDARY outcome
Timeframe: Between Day 13 and Day 15Population: Full Analysis Set
At end of study visit (V2) subject satisfaction regarding ease of use will be recorded using a 4-points categorical scale (How would you characterize the use of Healsea® Rescue\* nasal spray? 0: not easy ; 1: pretty easy ; 2: easy ; 3: very easy).
Outcome measures
| Measure |
Healsea Rescue* Group
n=100 Participants
Subjects will receive Healsea Rescue\* according to its intended use.
Healsea Rescue\*: Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
Placebo Group
n=100 Participants
Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.
Placebo: Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
|---|---|---|
|
Subject Satisfaction Regarding Ease of Use of the Nasal Spray
use not easy
|
0 Participants
|
1 Participants
|
|
Subject Satisfaction Regarding Ease of Use of the Nasal Spray
use pretty easy
|
4 Participants
|
3 Participants
|
|
Subject Satisfaction Regarding Ease of Use of the Nasal Spray
use easy
|
8 Participants
|
9 Participants
|
|
Subject Satisfaction Regarding Ease of Use of the Nasal Spray
use very easy
|
88 Participants
|
87 Participants
|
SECONDARY outcome
Timeframe: Between Day 13 and Day 15Population: Full Analysis Set
At end of study visit (V2) the residual taste after using the spray will be assessed by the subject using a 4-points categorical scale (How would you characterize the residual taste after spraying Healsea® Rescue\*?0: not pleasant ; 1: neutral ; 2: pleasant ; 3: very pleasant).
Outcome measures
| Measure |
Healsea Rescue* Group
n=100 Participants
Subjects will receive Healsea Rescue\* according to its intended use.
Healsea Rescue\*: Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
Placebo Group
n=100 Participants
Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.
Placebo: Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
|---|---|---|
|
Characterization of Residual Taste by the Subject
residual taste not pleasant
|
4 Participants
|
3 Participants
|
|
Characterization of Residual Taste by the Subject
residual taste neutral
|
59 Participants
|
61 Participants
|
|
Characterization of Residual Taste by the Subject
residual taste pleasant
|
21 Participants
|
21 Participants
|
|
Characterization of Residual Taste by the Subject
residual taste very pleasant
|
16 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Between Day 13 and Day 15Population: Full Analysis Set
At end of study visit (V2) cleansing and moistening of nasal mucosa will be assessed by the subject using a 4-points categorical scale (How would you characterize the cleansing and moistening of nasal mucosa with Healsea® Rescue\*?0: no improvement ; 1: slight improvement ; 2: moderate improvement; 3: very clear improvement).
Outcome measures
| Measure |
Healsea Rescue* Group
n=100 Participants
Subjects will receive Healsea Rescue\* according to its intended use.
Healsea Rescue\*: Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
Placebo Group
n=100 Participants
Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.
Placebo: Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
|---|---|---|
|
Characterization of Cleansing and Moistening of Nasal Mucosa With the Prescribed Treatment by the Subject
no improvement
|
3 Participants
|
5 Participants
|
|
Characterization of Cleansing and Moistening of Nasal Mucosa With the Prescribed Treatment by the Subject
slight improvement
|
11 Participants
|
11 Participants
|
|
Characterization of Cleansing and Moistening of Nasal Mucosa With the Prescribed Treatment by the Subject
moderate improvement
|
47 Participants
|
37 Participants
|
|
Characterization of Cleansing and Moistening of Nasal Mucosa With the Prescribed Treatment by the Subject
very clear improvement
|
39 Participants
|
47 Participants
|
Adverse Events
Healsea Rescue* Group
Placebo Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healsea Rescue* Group
n=100 participants at risk
Subjects will receive Healsea Rescue\* according to its intended use.
Healsea Rescue\*: Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
Placebo Group
n=100 participants at risk
Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.
Placebo: Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
|
|---|---|---|
|
General disorders
pyrexia
|
1.0%
1/100 • Number of events 1 • throughout the study, up to day 15
Reporting of Adverse events, incidents ( as per EU regulation 2017/745 requirements) and expected side effects Incident: Means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect. Expected side effects: identified in the manufacturer's labelling
|
6.0%
6/100 • Number of events 6 • throughout the study, up to day 15
Reporting of Adverse events, incidents ( as per EU regulation 2017/745 requirements) and expected side effects Incident: Means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect. Expected side effects: identified in the manufacturer's labelling
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
1.0%
1/100 • Number of events 1 • throughout the study, up to day 15
Reporting of Adverse events, incidents ( as per EU regulation 2017/745 requirements) and expected side effects Incident: Means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect. Expected side effects: identified in the manufacturer's labelling
|
1.0%
1/100 • Number of events 1 • throughout the study, up to day 15
Reporting of Adverse events, incidents ( as per EU regulation 2017/745 requirements) and expected side effects Incident: Means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect. Expected side effects: identified in the manufacturer's labelling
|
|
Respiratory, thoracic and mediastinal disorders
nasal disconfort
|
1.0%
1/100 • Number of events 1 • throughout the study, up to day 15
Reporting of Adverse events, incidents ( as per EU regulation 2017/745 requirements) and expected side effects Incident: Means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect. Expected side effects: identified in the manufacturer's labelling
|
1.0%
1/100 • Number of events 1 • throughout the study, up to day 15
Reporting of Adverse events, incidents ( as per EU regulation 2017/745 requirements) and expected side effects Incident: Means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect. Expected side effects: identified in the manufacturer's labelling
|
|
General disorders
Application site disconfort
|
1.0%
1/100 • Number of events 1 • throughout the study, up to day 15
Reporting of Adverse events, incidents ( as per EU regulation 2017/745 requirements) and expected side effects Incident: Means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect. Expected side effects: identified in the manufacturer's labelling
|
0.00%
0/100 • throughout the study, up to day 15
Reporting of Adverse events, incidents ( as per EU regulation 2017/745 requirements) and expected side effects Incident: Means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect. Expected side effects: identified in the manufacturer's labelling
|
|
General disorders
Application site pain
|
1.0%
1/100 • Number of events 1 • throughout the study, up to day 15
Reporting of Adverse events, incidents ( as per EU regulation 2017/745 requirements) and expected side effects Incident: Means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect. Expected side effects: identified in the manufacturer's labelling
|
0.00%
0/100 • throughout the study, up to day 15
Reporting of Adverse events, incidents ( as per EU regulation 2017/745 requirements) and expected side effects Incident: Means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect. Expected side effects: identified in the manufacturer's labelling
|
|
Nervous system disorders
paraesthesia
|
3.0%
3/100 • Number of events 3 • throughout the study, up to day 15
Reporting of Adverse events, incidents ( as per EU regulation 2017/745 requirements) and expected side effects Incident: Means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect. Expected side effects: identified in the manufacturer's labelling
|
1.0%
1/100 • Number of events 1 • throughout the study, up to day 15
Reporting of Adverse events, incidents ( as per EU regulation 2017/745 requirements) and expected side effects Incident: Means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect. Expected side effects: identified in the manufacturer's labelling
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhea
|
1.0%
1/100 • Number of events 1 • throughout the study, up to day 15
Reporting of Adverse events, incidents ( as per EU regulation 2017/745 requirements) and expected side effects Incident: Means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect. Expected side effects: identified in the manufacturer's labelling
|
0.00%
0/100 • throughout the study, up to day 15
Reporting of Adverse events, incidents ( as per EU regulation 2017/745 requirements) and expected side effects Incident: Means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect. Expected side effects: identified in the manufacturer's labelling
|
|
General disorders
unpleasant and bitter feeling
|
1.0%
1/100 • Number of events 1 • throughout the study, up to day 15
Reporting of Adverse events, incidents ( as per EU regulation 2017/745 requirements) and expected side effects Incident: Means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect. Expected side effects: identified in the manufacturer's labelling
|
0.00%
0/100 • throughout the study, up to day 15
Reporting of Adverse events, incidents ( as per EU regulation 2017/745 requirements) and expected side effects Incident: Means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect. Expected side effects: identified in the manufacturer's labelling
|
|
General disorders
nasal cavity pain
|
0.00%
0/100 • throughout the study, up to day 15
Reporting of Adverse events, incidents ( as per EU regulation 2017/745 requirements) and expected side effects Incident: Means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect. Expected side effects: identified in the manufacturer's labelling
|
1.0%
1/100 • Number of events 1 • throughout the study, up to day 15
Reporting of Adverse events, incidents ( as per EU regulation 2017/745 requirements) and expected side effects Incident: Means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect. Expected side effects: identified in the manufacturer's labelling
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60