Trial Outcomes & Findings for BАbykids Spray In Common Cold (NCT NCT05819203)
NCT ID: NCT05819203
Last Updated: 2024-10-08
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
| 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
| 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
| 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=99 Participants
|
4.0 years
STANDARD_DEVIATION 1.2 • n=107 Participants
|
4.0 years
STANDARD_DEVIATION 1.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
100 Participants
n=99 Participants
|
100 Participants
n=107 Participants
|
200 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 10Population: 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
| Measure |
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) .
|
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) .
|
|---|---|---|
|
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)
|
93.6 score on a scale*day
Standard Deviation 28.9
|
78.1 score on a scale*day
Standard Deviation 28.9
|
PRIMARY outcome
Timeframe: From Day 1 to Day 10Population: 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
| Measure |
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) .
|
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) .
|
|---|---|---|
|
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)
|
96 score on a scale*day
Standard Deviation 29.5
|
80.5 score on a scale*day
Standard Deviation 28.2
|
SECONDARY outcome
Timeframe: Through study completion, up to Day 18Population: 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
| Measure |
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) .
|
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) .
|
|---|---|---|
|
Duration of Each Cold Symptom (Questions 2 to 7 of the ARSSQ) in Both Groups
|
7.61 Number of days
Standard Deviation 2.05
|
6.92 Number of days
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: Through study completion, up to Day 18Population: 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
| Measure |
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) .
|
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) .
|
|---|---|---|
|
Duration of Quality-of-life Impairment (Questions 8 to 10 of the ARSSQ).
|
7.03 Duration in Days
Standard Deviation 1.97
|
6.46 Duration in Days
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: Through study completion, up to Day 18Population: 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
| Measure |
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) .
|
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) .
|
|---|---|---|
|
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)
|
389 number of days
|
317 number of days
|
SECONDARY outcome
Timeframe: through study completion , up to day 18Population: 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
| Measure |
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) .
|
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) .
|
|---|---|---|
|
Cumulative Number of Days of Antibiotics Intake
|
127 number of days
|
108 number of days
|
SECONDARY outcome
Timeframe: through study completion, up to day 18Population: 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
| Measure |
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) .
|
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) .
|
|---|---|---|
|
Cumulative Number of Days of Antipyretics Intake
|
86 number of days
|
62 number of days
|
SECONDARY outcome
Timeframe: Through study completion , up to day 18Population: 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
| Measure |
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) .
|
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) .
|
|---|---|---|
|
Cumulative Number of Days of Mucolytics Intake
|
85 number of days
|
44 number of days
|
SECONDARY outcome
Timeframe: through study completion, up to day 18Population: 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
| Measure |
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) .
|
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) .
|
|---|---|---|
|
Cumulative Number of Days of Decongestants Use
|
220 number of days
|
149 number of days
|
SECONDARY outcome
Timeframe: through study completion, up to day 18Population: 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
| Measure |
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) .
|
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) .
|
|---|---|---|
|
Cumulative Number of Days of Antitussives Use
|
18 number of days
|
23 number of days
|
SECONDARY outcome
Timeframe: Through study completion, up to day 18Population: 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
| Measure |
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) .
|
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) .
|
|---|---|---|
|
Cumulative Number of Days of Systemic and Topical Corticosteroids Use
|
66 number of days
|
25 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
| 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).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60