Trial Outcomes & Findings for Effect of Squeezable Bottle Nasal Irrigation Device in Children With Sinusitis (NCT NCT02191046)

Results Overview

For 5S-score, we measured the the mean 5-s score of both group at 2 weeks compare to the mean 5-s score at baseline visit and compare 5S-score between group at 2 weeks. The S5- score is a scale assessing severity of sinusitis. It compose of the symptom scores for nasal obstruction, day and nighttime cough, headache and nasal discharge. All symptom were graded from 0(no symptom) to 3 (severe ).The score were summed to give the mean 5S-score.It range from 0 (best possible outcome) to 15(worst possible outcome). 7-point Likert scale for satisfaction score is scale from 1 (indicating unsatisfactory) to 7 (indicating excellent). For satisfaction, we reported the result in the term of 7 points Likert scale and compare these scale between group at 2 weeks after treatment

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

compare 5S-score of both group at 2 week and at baseline visit .compare the mean 5S-score and satisfaction score between both group at 2 weeks after treatment

Results posted on

2014-11-04

Participant Flow

we enrolled sinusitis patient age 3-15 year during March 2013 - May 2014. We excluded patients with a history of penicillin allergy, nasal anatomic defects, immunodeficiency or had complication from sinusitis. Patient with low compliance defined as the rate usage nasal irrigation estimated at less than 80% were excluded

Participant milestones

Participant milestones
Measure	Syringe 20 ml nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge syringe 20 ml: nasal irrigation twice daily for 2 weeks period	Squeezable Bottle nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge squeezable bottle: nasal irrigation twice daily for 2 weeks period
Overall Study STARTED	41	39
Overall Study COMPLETED	36	38
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Syringe 20 ml nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge syringe 20 ml: nasal irrigation twice daily for 2 weeks period	Squeezable Bottle nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge squeezable bottle: nasal irrigation twice daily for 2 weeks period
Overall Study low compliance	5	1

Baseline Characteristics

Effect of Squeezable Bottle Nasal Irrigation Device in Children With Sinusitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Syringe 20 ml n=36 Participants nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge syringe 20 ml: nasal irrigation twice daily for 2 weeks period	Squeezable Bottle n=38 Participants nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge squeezable bottle: nasal irrigation twice daily for 2 weeks period	Total n=74 Participants Total of all reporting groups
Age, Categorical <=18 years	36 Participants n=5 Participants	38 Participants n=7 Participants	74 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	16 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	22 Participants n=7 Participants	47 Participants n=5 Participants
Region of Enrollment Thailand	36 participants n=5 Participants	38 participants n=7 Participants	74 participants n=5 Participants

PRIMARY outcome

Timeframe: compare 5S-score of both group at 2 week and at baseline visit .compare the mean 5S-score and satisfaction score between both group at 2 weeks after treatment

Population: The S5- score is the symptom scores for nasal obstruction, day and nighttime cough, headache and nasal discharge. All symptom were graded from 0(no symptom) to 3 (severe ).The score were summed to give the mean 5S-score.7-point Likert scale for satisfaction score is scale from 1 (indicating unsatisfactory) to 7 (indicating excellent).

For 5S-score, we measured the the mean 5-s score of both group at 2 weeks compare to the mean 5-s score at baseline visit and compare 5S-score between group at 2 weeks. The S5- score is a scale assessing severity of sinusitis. It compose of the symptom scores for nasal obstruction, day and nighttime cough, headache and nasal discharge. All symptom were graded from 0(no symptom) to 3 (severe ).The score were summed to give the mean 5S-score.It range from 0 (best possible outcome) to 15(worst possible outcome). 7-point Likert scale for satisfaction score is scale from 1 (indicating unsatisfactory) to 7 (indicating excellent). For satisfaction, we reported the result in the term of 7 points Likert scale and compare these scale between group at 2 weeks after treatment

Outcome measures

Outcome measures
Measure	Syringe 20 ml n=36 Participants improve 5-s score at 2 week period after treatment when compare to the beginning status with minimal side effect	Squeezable Bottle n=38 Participants improve 5-s score at 2 week period after treatment when compare to the beginning status with minimal side effect and significant improve in 5-s score and satisfaction when compare to syringe group
the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children 5S-score at baseline	6.56 units on a scale Standard Deviation 2.35	6.89 units on a scale Standard Deviation 2.49
the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children 5S-score at 2 weeks	2.17 units on a scale Standard Deviation 2.03	1.24 units on a scale Standard Deviation 1.55
the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children satisfaction score at baseline	5.11 units on a scale Standard Deviation 1.19	5.97 units on a scale Standard Deviation 1.31
the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children satisfaction score at 2 weeks	6.11 units on a scale Standard Deviation 0.85	6.57 units on a scale Standard Deviation 0.64

SECONDARY outcome

Timeframe: at second week after treatment

compare the result of bacterial culture in both group of nasal irrigation devices. We reported in the following item; no growth, gram positive or gram negative or mixed organism

Outcome measures

Outcome data not reported

Adverse Events

Syringe 20 ml

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Squeezable Bottle

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Syringe 20 ml n=36 participants at risk record adverse event at baseline and daily adverse events until 2 weeks after treatment	Squeezable Bottle n=38 participants at risk record adverse event at baseline and daily adverse events until 2 weeks after treatment
Respiratory, thoracic and mediastinal disorders nasal irritation	16.7% 6/36 • Number of events 10 • we monitor side effect from the beginning of treatment until 2 weeks after treatment we monitor side effect from the beginning of treatment until 2 weeks after treatment. the physician asking the symptoms after nasal irrigation at baseline visit then the symptoms were recorded daily by parents and noted in diary card	5.3% 2/38 • Number of events 3 • we monitor side effect from the beginning of treatment until 2 weeks after treatment we monitor side effect from the beginning of treatment until 2 weeks after treatment. the physician asking the symptoms after nasal irrigation at baseline visit then the symptoms were recorded daily by parents and noted in diary card
Respiratory, thoracic and mediastinal disorders nasal congestion	2.8% 1/36 • Number of events 2 • we monitor side effect from the beginning of treatment until 2 weeks after treatment we monitor side effect from the beginning of treatment until 2 weeks after treatment. the physician asking the symptoms after nasal irrigation at baseline visit then the symptoms were recorded daily by parents and noted in diary card	10.5% 4/38 • Number of events 5 • we monitor side effect from the beginning of treatment until 2 weeks after treatment we monitor side effect from the beginning of treatment until 2 weeks after treatment. the physician asking the symptoms after nasal irrigation at baseline visit then the symptoms were recorded daily by parents and noted in diary card
Ear and labyrinth disorders tinnitus	2.8% 1/36 • Number of events 2 • we monitor side effect from the beginning of treatment until 2 weeks after treatment we monitor side effect from the beginning of treatment until 2 weeks after treatment. the physician asking the symptoms after nasal irrigation at baseline visit then the symptoms were recorded daily by parents and noted in diary card	2.6% 1/38 • Number of events 1 • we monitor side effect from the beginning of treatment until 2 weeks after treatment we monitor side effect from the beginning of treatment until 2 weeks after treatment. the physician asking the symptoms after nasal irrigation at baseline visit then the symptoms were recorded daily by parents and noted in diary card

Additional Information

Dr.Araya Satdhabudha

Thammasat university

Phone: 0813414900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place