CompletedNCT00747747SToSSUpdated Mar 14, 2012Results posted

Sinuclean's Treatment Of Sinusitis' Symptoms

A Phase 4 interventional study of Saline solution and Sinuclean DM Spray in Sinusitis, sponsored by Galsor S.r.l.. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-14.

Sponsored by Galsor S.r.l. · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 49
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The goal of the study is to demonstrate that SINUclean DM® spray, added to the standard (amoxicillin/clavulanate) therapy of the acute episode of sinusitis (acute, subacute or chronic), is safe ad capable to determine the resolution of the symptoms in a shorter time in comparison with the standard therapy without co-adjuvant, or with simple saline lavage.

Read the detailed description

The randomized subject with diagnosis of acute episode of sinusitis with symptoms and mucus in the paranasal sinuses, will treat his/her condition with background amoxicillin/clavulanate and with inhalation of Sinuclean or Saline, while the control group will not use any spray for symptom relief. Anti-histaminic, steroidal anti-inflammatory drugs are forbidden. The patient is requested to evaluate his state of symptoms by recording in a diary

the pain or feeling of facial oppression;
nasal dripping anterior or posterior;
nasal congestion. SCALE 0 = no symptom
1. = mild symptom: clearly perceptible, but easily tolerated
2. = moderate symptom: clear awareness of the symptom, that is annoying but tolerable
3. = severe: symptom very annoying, difficult to tolerate, interfering with the ordinary life Four measures per day (2 for administration of the therapy - before/after) of which the median will be used; plus an evening measure "retrospective" of the past 12 hours.

If possible it will be assessed the status of paranasal sinuses before and after the treatment with a CT scan.

The treatment intervals is the week. After baseline and start of treatment, are planned two control visit. The subject will complete the study at the first control visit without symptoms. After the second visit, if the symptoms are still present, the subject will complete as a "treatment-failure".

Conditions studied

Sinusitis

Browse trials for

Sinusitis 415

Keywords

Sinusitis

In context

Sinusitis

415 studies on the registry are indexed under Sinusitis; 46 are open to participants now.

This study's enrollment of 49 is below the median of 60 across 313 interventional studies indexed under Sinusitis.

Browse Sinusitis studies →

Lead sponsor

Galsor S.r.l. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Male or female sex.
Age > 18 years old.
Diagnosis of acute episode of sinusitis (in an acute, subacute or chronic background), confirmed with a CT scan image.
Presence of mucus in para-nasal sinuses.
Symptoms of facial pain associated to the congestion of the mucosa of the paranasal sinuses for at least three days.
Written informed consent.
Expressed intention of compliance with the study requirements.

Exclusion criteria

Exclusion Criteria:

In case of female subject: ongoing pregnancy or lactating; or condition of fecundity without abstinence.
Assumption, during the study, of drugs that can interfere with the evaluation of the investigational drug (see Section "Concomitant Therapy")
Possible necessity of treatment, during the study, with drugs that are not allowed (see section "Concomitant Therapy").
Clinical conditions (systemic pathologies or other) that can interfere with the assessment of the safety and efficacy of the investigational drug, in example: viral or allergic rhinitis with active secretive symptomatology, presence of visible nasal polyps, diagnosis of immobile cilia syndrome, diseases determining immunodeficiency cystic fibrosis immunocompromission renal insufficiency, dialysis, pathology of other apparatus that, in the opinion of the investigator, necessity of a supplementary antibiotic therapy,due to other pathologies, besides the one standard of the sinusitis.
Psychical conditions not compatible with the participation to the clinical trial.
Alcohol abuse or other dependencies on stupefacents
Smoking during the period of the study
History of intolerance or allergy to the components of SINUclean DM®
Surgical or medical intervention that can jeopardize the complete performance of the trial, in the 4 wks preceding the administration of the informed consent
Planning of a surgical or medical intervention that can jeopardize the completion of the trial
Participation to other clinical trials, ongoing or terminated since less than 30 days before the beginning of the present experiment.
Preceding randomization in this trial.
Be component of the investigators' staff or be a relative of a member of the staff.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 49 participants (actual)

Study arms

No intervention
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.
Active comparator
Saline solution
Saline solution sprayed according to the product indication. Only one brand/specific product has been selected.
Biological: Saline solution
Experimental
Sinuclean treatment
Sinuclean DM Spray.
Device: Sinuclean DM Spray

Interventions

BiologicalSaline solution
3 sprays per nostrils twice a day (morning and evening); in case of need a third nebulization between the two is allowed
Also known as: Libenar
DeviceSinuclean DM Spray
3 sprays per nostrils twice a day (morning and evening); in case of need a third nebulization between the two is allowed
Also known as: Sinuclean DM Nasal Spray

What researchers measure

Primary outcomes

Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)
Mucus detection in paranasal sinuses by clinical assessment(Outcome measure Percentage of patients)
Time frame: After one week
Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)
Mucus detection in paranasal sinuses by clinical assessment(Outcome Measure Percentage of patients)
Time frame: After two weeks

Secondary outcomes

FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject
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
Time frame: After one week
FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject
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.
Time frame: After two weeks
Recovery of Sinusitis Per Clinical Assessment(Outcome Measure Percentage of Patients)
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.
Time frame: After one week
Recovery of Sinusitis Per Clinical Assessment (Outcome Measure Percentage of Patients)
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.
Time frame: After two weeks

Results

Posted Mar 14, 2012

Limitations and caveats

Clinical diagnosis could not be confirmed before treatment start due to logistics problems to make cranial MRI in due time.

Participant flow

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

Participant flow — Overall Study
Milestone	Control	Saline Treated.	Sinuclean Treated.
Started	14	14	21
Completed	14	14	21
Not completed	0	0	0

Outcome measures

PrimaryPresence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)

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

Time frame:: After one week
Reported as:: Number · percentage of patients

Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)
percentage of patients	Control	Saline Treated.	Sinuclean Treated.
Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)	71	57	33

Statistical analysis

Control vs Saline Treated. vs Sinuclean Treated. · Chi-squared · p = <0.05 · Frequency: 0

SecondaryFACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject

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

Time frame:: After one week
Reported as:: Number · percentage of patients

FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject
percentage of patients	Control	Saline Treated.	Sinuclean Treated.
FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject	57	43	52

SecondaryFACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject

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.

Time frame:: After two weeks
Reported as:: Number · percentage of patients

FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject
percentage of patients	Control	Saline Treated.	Sinuclean Treated.
FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject	79	93	81

PrimaryPresence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)

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

Time frame:: After two weeks
Reported as:: Number · percentage of patients

Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)
percentage of patients	Control	Saline Treated.	Sinuclean Treated.
Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)	29	29	15

SecondaryRecovery of Sinusitis Per Clinical Assessment(Outcome Measure Percentage of Patients)

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.

Time frame:: After one week
Reported as:: Number · percentage of patients

Recovery of Sinusitis Per Clinical Assessment(Outcome Measure Percentage of Patients)
percentage of patients	Control	Saline Treated.	Sinuclean Treated.
Recovery of Sinusitis Per Clinical Assessment(Outcome Measure Percentage of Patients)	29	29	52

SecondaryRecovery of Sinusitis Per Clinical Assessment (Outcome Measure Percentage of Patients)

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.

Time frame:: After two weeks
Reported as:: Number · percentage of patients

Recovery of Sinusitis Per Clinical Assessment (Outcome Measure Percentage of Patients)
percentage of patients	Control	Saline Treated.	Sinuclean Treated.
Recovery of Sinusitis Per Clinical Assessment (Outcome Measure Percentage of Patients)	57	64	90

Statistical analysis

Control vs Saline Treated. vs Sinuclean Treated. · Chi-squared · p = <0.05 · Frequency: 0

Adverse events

Collected over 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.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Control	—	0/14 (0%)	0/14 (0%)
Saline Treated.	—	0/14 (0%)	1/14 (7.1%)
Sinuclean Treated.	—	0/21 (0%)	0/21 (0%)

Most frequent other events

Most frequent other events
Event	Control	Saline Treated.	Sinuclean Treated.
Flu syndromeRespiratory, thoracic and mediastinal disorders	0/14	1/14	0/21

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Control	Saline Treated.	Sinuclean Treated.	Total
<=18 years	0	0	0	0
Between 18 and 65 years	14	14	21	49
>=65 years	0	0	0	0

Age Continuous
Age Continuous(years)	Control	Saline Treated.	Sinuclean Treated.	Total
Mean	45 ± 15	45 ± 11	48 ± 13	47 ± 13

Sex: Female, Male
Sex: Female, Male(Participants)	Control	Saline Treated.	Sinuclean Treated.	Total
Female	8	5	11	24
Male	6	9	10	25

Region of Enrollment
Region of Enrollment(participants)	Control	Saline Treated.	Sinuclean Treated.	Total
Italy	14	14	21	49

Study locations

1 site

University Cattolica del Sacro Cuore
Rome, Lazio 00168, Italy

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 14, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00747747
Lead sponsor: Galsor S.r.l.
Responsible party: Sponsor
First posted: Sep 5, 2008
Start date: Nov 2007
Primary completion: Jan 2009
Completion: Feb 2010
Results posted: Mar 14, 2012
Last update: Mar 14, 2012

Study contacts

Gaetano Paludetti, MD

principal investigator · University Cattolica del Sacro Cuore Roma Italy

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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