Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00747747
Other study ID # GAL-01-2007
Secondary ID EudraCT: 2007-00
Status Completed
Phase Phase 4
First received September 4, 2008
Last updated March 12, 2012
Start date November 2007
Est. completion date February 2010

Study information

Verified date March 2012
Source Galsor S.r.l.
Contact n/a
Is FDA regulated No
Health authority Italy: The Italian Medicines Agency
Study type Interventional

Clinical Trial 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.


Description:

Read more »
Read more »

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
Saline solution
3 sprays per nostrils twice a day (morning and evening); in case of need a third nebulization between the two is allowed
Device:
Sinuclean DM Spray
3 sprays per nostrils twice a day (morning and evening); in case of need a third nebulization between the two is allowed

Locations

Country Name City State
Italy University Cattolica del Sacro Cuore Rome Lazio

Sponsors (1)

Lead Sponsor Collaborator
Galsor S.r.l.

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) After one week No
Primary 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) After two weeks Yes
Secondary 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 After one week No
Secondary 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. After two weeks No
Secondary 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. After one week No
Secondary 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. After two weeks No
See also
  Status Clinical Trial Phase
Recruiting NCT03584178 - The Long-Term Safety of Budesonide for Patients With Chronic Rhinosinusitis N/A
Completed NCT06016335 - MRI-based Synthetic CT Images of the Head and Neck N/A
Active, not recruiting NCT02278484 - Sinus Balloon Dilation in Pediatric Patients N/A
Withdrawn NCT02071667 - Association of Periostin Levels and Chronic Sinusitis N/A
Completed NCT01420471 - Medicated Punctured-Glove-Finger Spacer Study Phase 4
Completed NCT01118312 - Study of Asthma and Nasal Steroids Phase 4
Completed NCT00645762 - Balloon REmodeling Antrostomy THErapy Study Phase 2
Completed NCT01685229 - Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis
Active, not recruiting NCT03943121 - The Effects of Steroid-eluting Stent Implant for the Treatment of Eosinophilic Chronic Rhinosinusitis With Nasal Polyps N/A
Withdrawn NCT02900794 - Gold Laser Vs. Micro-Debriders for Functional Endoscopic Sinus Surgery N/A
Terminated NCT02630472 - Topical Irrigation Therapy for CRS Phase 1/Phase 2
Completed NCT01442740 - 15-Degree Tilt, Head Up, Feet Down Body Position for Sinus Surgery Patients N/A
Completed NCT01001039 - Validation of the Facial and Cephalic Pain Inventory N/A
Completed NCT01033799 - Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers N/A
Completed NCT00335309 - Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis N/A
Completed NCT00242437 - Hemostatic Matrix in Endoscopic Sinus Surgery Phase 4
Completed NCT00236522 - A Comparison of the Safety and Efficacy of Two Different Regimens of Levofloxacin in the Treatment of Acute Bacterial Sinusitis(Sinus Infection) in Adults. Phase 3
Completed NCT01717274 - Hot Saline Irrigation Study N/A
Completed NCT01166945 - Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children N/A
Not yet recruiting NCT00545961 - Middle Meatal Bacteriology During Acute Respiratory Infection in Children Phase 4

External Links