Trial Outcomes & Findings for BАbykids Spray In Common Cold (NCT NCT05819203)

Results Overview

ARSSQ is a non-validated customized questionnaire. It includes 10 items assessing symptoms (questions 2 to 7), functional impairments (8 to 10), and global severity (question 1). Each item is scored from 0 (not present/no impact/ not sick) to 3 (severe, severe impact and very sick) for symptoms, functional impairment and global severity respectively. The questionnaire is to be completed in a diary once daily in the evening. The minimum ARSSQ score is zero (0) and the maximum ARSSQ score is thirty (30).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

200 participants

Primary outcome timeframe

From Day 1 to Day 10

Results posted on

2024-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	Healsea Babykids Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Healsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .	Placebo The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Placebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .
Overall Study STARTED	100	100
Overall Study COMPLETED	98	98
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Healsea Babykids Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Healsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .	Placebo The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Placebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .
Overall Study Protocol Violation	1	2
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

BАbykids Spray In Common Cold

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healsea Babykids n=100 Participants Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Healsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .	Placebo n=100 Participants The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Placebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .	Total n=200 Participants Total of all reporting groups
Age, Continuous	3.9 years STANDARD_DEVIATION 1.1 • n=5 Participants	4.0 years STANDARD_DEVIATION 1.2 • n=7 Participants	4.0 years STANDARD_DEVIATION 1.1 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	49 Participants n=7 Participants	97 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants	51 Participants n=7 Participants	103 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	100 Participants n=5 Participants	100 Participants n=7 Participants	200 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 10

Population: FAS: all the subjects from the Safety Population and with at least one post-baseline efficacy data

ARSSQ is a non-validated customized questionnaire. It includes 10 items assessing symptoms (questions 2 to 7), functional impairments (8 to 10), and global severity (question 1). Each item is scored from 0 (not present/no impact/ not sick) to 3 (severe, severe impact and very sick) for symptoms, functional impairment and global severity respectively. The questionnaire is to be completed in a diary once daily in the evening. The minimum ARSSQ score is zero (0) and the maximum ARSSQ score is thirty (30).

Outcome measures

Outcome measures
Measure	Healsea Babykids n=100 Participants Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Healsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .	Placebo n=100 Participants The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Placebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .
The Area Under the Curve (AUC) of the Global Score of the Acute Rhinitis Symptoms Severity Questionnaire (ARSSQ) During First 10 Days of Symptoms - Full Analysis Set (FAS)	78.1 score on a scale*day Standard Deviation 28.9	93.6 score on a scale*day Standard Deviation 28.9

PRIMARY outcome

Timeframe: From Day 1 to Day 10

Population: PP: efficacy population based on the FAS for subjects without major protocol deviation

ARSSQ is a non-validated customized questionnaire. It includes 10 items assessing symptoms (questions 2 to 7), functional impairments (8 to 10), and global severity (question 1). Each item is scored from 0 (not present/no impact/ not sick) to 3 (severe, severe impact and very sick) for symptoms, functional impairment and global severity respectively. The questionnaire is to be completed in a diary once daily in the evening. The minimum ARSSQ score is zero (0) and the maximum ARSSQ score is thirty (30).

Outcome measures

Outcome measures
Measure	Healsea Babykids n=62 Participants Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Healsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .	Placebo n=62 Participants The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Placebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .
The Area Under the Curve (AUC) of the Global Score of the Acute Rhinitis Symptoms Severity Questionnaire (ARSSQ) During First 10 Days of Symptoms - Per Protocol Set (PP)	80.5 score on a scale*day Standard Deviation 28.2	96 score on a scale*day Standard Deviation 29.5

SECONDARY outcome

Timeframe: Through study completion, up to Day 18

Population: Full Analysis Set (FAS)

For each separate symptom, the duration is defined as the number of days between Day 1 and the first day the parent/legal guardian reports the patient not having this symptom ("Not present") for 2 consecutive days. Duration may be censored at Visit 2.

Outcome measures

Outcome measures
Measure	Healsea Babykids n=100 Participants Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Healsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .	Placebo n=100 Participants The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Placebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .
Duration of Each Cold Symptom (Questions 2 to 7 of the ARSSQ) in Both Groups	6.92 Number of days Standard Deviation 2.14	7.61 Number of days Standard Deviation 2.05

SECONDARY outcome

Timeframe: Through study completion, up to Day 18

Population: Full Analysis Set (FAS)

For each separate symptom, the duration is defined as the number of days between Day 1 and the first day the parent/legal guardian reports the patient not having this symptom ("Not present") for 2 consecutive days. Duration may be censored at Visit 2.

Outcome measures

Outcome measures
Measure	Healsea Babykids n=100 Participants Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Healsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .	Placebo n=100 Participants The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Placebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .
Duration of Quality-of-life Impairment (Questions 8 to 10 of the ARSSQ).	6.46 Duration in Days Standard Deviation 1.92	7.03 Duration in Days Standard Deviation 1.97

SECONDARY outcome

Timeframe: Through study completion, up to Day 18

Population: Full Analysis Set

Concomitant treatments use (antibiotics, antipyretics, systemic or local mucolytics, decongestants, antitussives, systemic and topical corticosteroids) will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.

Outcome measures

Outcome measures
Measure	Healsea Babykids n=100 Participants Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Healsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .	Placebo n=100 Participants The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Placebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .
Cumulative Number of Days of Concomitant Treatments Use That May Affect Common Cold Symptoms (Antibiotics, Antipyretics, Systemic or Local Mucolytics, Decongestants, Antitussives, Systemic and Topical Corticosteroids)	317 number of days	389 number of days

SECONDARY outcome

Timeframe: through study completion , up to day 18

Population: Full Analysis Set

Antibiotics use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.

Outcome measures

Outcome measures
Measure	Healsea Babykids n=100 Participants Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Healsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .	Placebo n=100 Participants The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Placebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .
Cumulative Number of Days of Antibiotics Intake	108 number of days	127 number of days

SECONDARY outcome

Timeframe: through study completion, up to day 18

Population: Full Analysis Set

Antipyretics use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.

Outcome measures

Outcome measures
Measure	Healsea Babykids n=100 Participants Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Healsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .	Placebo n=100 Participants The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Placebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .
Cumulative Number of Days of Antipyretics Intake	62 number of days	86 number of days

SECONDARY outcome

Timeframe: Through study completion , up to day 18

Population: Full Analysis Set

Mucolytics use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.

Outcome measures

Outcome measures
Measure	Healsea Babykids n=100 Participants Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Healsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .	Placebo n=100 Participants The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Placebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .
Cumulative Number of Days of Mucolytics Intake	44 number of days	85 number of days

SECONDARY outcome

Timeframe: through study completion, up to day 18

Population: Full Analysis Set

Decongestants use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.

Outcome measures

Outcome measures
Measure	Healsea Babykids n=100 Participants Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Healsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .	Placebo n=100 Participants The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Placebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .
Cumulative Number of Days of Decongestants Use	149 number of days	220 number of days

SECONDARY outcome

Timeframe: through study completion, up to day 18

Population: Full Analysis Set

Antitussives use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.

Outcome measures

Outcome measures
Measure	Healsea Babykids n=100 Participants Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Healsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .	Placebo n=100 Participants The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Placebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .
Cumulative Number of Days of Antitussives Use	23 number of days	18 number of days

SECONDARY outcome

Timeframe: Through study completion, up to day 18

Population: Full Analysis Set

Systemic and topical corticosteroids use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.

Outcome measures

Outcome measures
Measure	Healsea Babykids n=100 Participants Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Healsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .	Placebo n=100 Participants The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Placebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .
Cumulative Number of Days of Systemic and Topical Corticosteroids Use	25 number of days	66 number of days

Adverse Events

Healsea Babykids

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr Bernard Gout

Pharmndev Experts

Phone: +41798659000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Healsea Babykids n=100 participants at risk Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Healsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .	Placebo n=100 participants at risk The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Placebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .
Infections and infestations tonsillitis	3.0% 3/100 • Number of events 3 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).	5.0% 5/100 • Number of events 5 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).
Infections and infestations otitis media acute	0.00% 0/100 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).	2.0% 2/100 • Number of events 2 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).
Infections and infestations Scarlet fever	1.0% 1/100 • Number of events 1 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).	1.0% 1/100 • Number of events 1 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).
Infections and infestations bronchiolitis	0.00% 0/100 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).	1.0% 1/100 • Number of events 1 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).
Infections and infestations influenza	0.00% 0/100 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).	1.0% 1/100 • Number of events 1 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).
Infections and infestations laryngitis	1.0% 1/100 • Number of events 1 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).	0.00% 0/100 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).
Infections and infestations pharyngitis	0.00% 0/100 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).	1.0% 1/100 • Number of events 1 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).
General disorders Pyrexia	2.0% 2/100 • Number of events 3 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).	2.0% 2/100 • Number of events 2 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).
Respiratory, thoracic and mediastinal disorders Cough	1.0% 1/100 • Number of events 3 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).	1.0% 1/100 • Number of events 1 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/100 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).	1.0% 1/100 • Number of events 1 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).
Ear and labyrinth disorders ear pain	1.0% 1/100 • Number of events 1 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).	0.00% 0/100 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).
Ear and labyrinth disorders inner ear inflammation	1.0% 1/100 • Number of events 1 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).	0.00% 0/100 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).
Respiratory, thoracic and mediastinal disorders epistaxis	1.0% 1/100 • Number of events 1 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).	0.00% 0/100 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).
Skin and subcutaneous tissue disorders pruritus	0.00% 0/100 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).	1.0% 1/100 • Number of events 1 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).
Skin and subcutaneous tissue disorders Rash	0.00% 0/100 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).	1.0% 1/100 • Number of events 1 • Adverse events were collected during the intervention through the study completion , up to day 18 Reporting of adverse events and of incidents (Incident: 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).