Trial Outcomes & Findings for Sinuclean's Treatment Of Sinusitis' Symptoms (NCT NCT00747747)

Results Overview

Mucus detection in paranasal sinuses by clinical assessment(Outcome measure Percentage of patients)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

49 participants

Primary outcome timeframe

After one week

Results posted on

2012-03-14

Participant Flow

Period of recruitment: Nov 2007 - Mar 2009 Location: Outpatients attending medical visits by General Practitioners

Participant milestones

Participant milestones
Measure	Control No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.	Saline Treated. Saline solution sprayed three times in each nostril, twice a day (morning - evening)	Sinuclean Treated. Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
Overall Study STARTED	14	14	21
Overall Study COMPLETED	14	14	21
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sinuclean's Treatment Of Sinusitis' Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=14 Participants No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.	Saline Treated. n=14 Participants Saline solution sprayed three times in each nostril, twice a day (morning - evening)	Sinuclean Treated. n=21 Participants Sinuclean sprayed three times in each nostril, twice a day (morning - evening)	Total n=49 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	14 Participants n=7 Participants	21 Participants n=5 Participants	49 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	45 years STANDARD_DEVIATION 15 • n=5 Participants	45 years STANDARD_DEVIATION 11 • n=7 Participants	48 years STANDARD_DEVIATION 13 • n=5 Participants	47 years STANDARD_DEVIATION 13 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants	24 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	25 Participants n=4 Participants
Region of Enrollment Italy	14 participants n=5 Participants	14 participants n=7 Participants	21 participants n=5 Participants	49 participants n=4 Participants

PRIMARY outcome

Timeframe: After one week

Population: The patients were eligible according to inclusion and exclusion criteria and were compliant with the study requirements.

Mucus detection in paranasal sinuses by clinical assessment(Outcome measure Percentage of patients)

Outcome measures

Outcome measures
Measure	Control n=14 Participants No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.	Saline Treated. n=14 Participants Saline solution sprayed three times in each nostril, twice a day (morning - evening)	Sinuclean Treated. n=21 Participants Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)	71 percentage of patients	57 percentage of patients	33 percentage of patients

PRIMARY outcome

Timeframe: After two weeks

Mucus detection in paranasal sinuses by clinical assessment(Outcome Measure Percentage of patients)

Outcome measures

Outcome measures
Measure	Control n=14 Participants No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.	Saline Treated. n=14 Participants Saline solution sprayed three times in each nostril, twice a day (morning - evening)	Sinuclean Treated. n=21 Participants Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)	29 percentage of patients	29 percentage of patients	15 percentage of patients

SECONDARY outcome

Timeframe: After one week

Population: Eligibility per in/ex criteria and compliance with study requirements and diary completion requirements

Patient's daily diary retrospective ranked assessment of symptoms (0,1,2,3 with 0 = no symptoms; frequencies of patients with rank "0" were compared as outcome measure between groups

Outcome measures

Outcome measures
Measure	Control n=14 Participants No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.	Saline Treated. n=14 Participants Saline solution sprayed three times in each nostril, twice a day (morning - evening)	Sinuclean Treated. n=21 Participants Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject	57 percentage of patients	43 percentage of patients	52 percentage of patients

SECONDARY outcome

Timeframe: After two weeks

Patient's daily diary retrospective ranked assessment of symptoms (0,1,2,3 with 0 = no symptoms; frequencies of patients with rank "0" were compared as outcome measure between groups.

Outcome measures

Outcome measures
Measure	Control n=14 Participants No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.	Saline Treated. n=14 Participants Saline solution sprayed three times in each nostril, twice a day (morning - evening)	Sinuclean Treated. n=21 Participants Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject	79 percentage of patients	93 percentage of patients	81 percentage of patients

SECONDARY outcome

Timeframe: After one week

Population: Eligibility according to in/ex criteria and compliance with study requirements

Clinical assessment of healing of the sinusitis episode(Outcome Measure Percentage of patients healed). Healing was assessed clinically by the physician as recovery of the condition prior to the diagnosis of the episode of sinusitis, without need of medical treatment.

Outcome measures

Outcome measures
Measure	Control n=14 Participants No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.	Saline Treated. n=14 Participants Saline solution sprayed three times in each nostril, twice a day (morning - evening)	Sinuclean Treated. n=21 Participants Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
Recovery of Sinusitis Per Clinical Assessment(Outcome Measure Percentage of Patients)	29 percentage of patients	29 percentage of patients	52 percentage of patients

SECONDARY outcome

Timeframe: After two weeks

Clinical assessment of healing of the sinusitis episode (Outcome Measure Percentage of patients healed. Healing was assessed clinically by the physician as recovery of the condition prior to the diagnosis of the episode of sinusitis, without need of medical treatment.

Outcome measures

Outcome measures
Measure	Control n=14 Participants No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.	Saline Treated. n=14 Participants Saline solution sprayed three times in each nostril, twice a day (morning - evening)	Sinuclean Treated. n=21 Participants Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
Recovery of Sinusitis Per Clinical Assessment (Outcome Measure Percentage of Patients)	57 percentage of patients	64 percentage of patients	90 percentage of patients

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline Treated.

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Sinuclean Treated.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Control n=14 participants at risk No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.	Saline Treated. n=14 participants at risk Saline solution sprayed three times in each nostril, twice a day (morning - evening)	Sinuclean Treated. n=21 participants at risk Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
Respiratory, thoracic and mediastinal disorders Flu syndrome	0.00% 0/14 • The period in which Adverse Events were collected was the period of observation of the patient between the Start and the End of the therapy: two weeks maximum. A 0 frequency means that no events were reported or observed in all the patients of the group considered.	7.1% 1/14 • Number of events 1 • The period in which Adverse Events were collected was the period of observation of the patient between the Start and the End of the therapy: two weeks maximum. A 0 frequency means that no events were reported or observed in all the patients of the group considered.	0.00% 0/21 • The period in which Adverse Events were collected was the period of observation of the patient between the Start and the End of the therapy: two weeks maximum. A 0 frequency means that no events were reported or observed in all the patients of the group considered.

Additional Information

Dr. Sandro Soriano/Director of Clinical Trials

Galsor s.r.l.

Phone: 0039 0827 601723

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place