A Study of Luffa Operculate Nasal Solution 5mg/mL Compared With Saline (NaCl 09%) for the Relief of Nasal Obstruction

Clinical Trial Unicenter, Phase III, Randomized, Double-blind, Comparative to Evaluate the Efficacy, Tolerability and Superiority of Luffa Operculate Nasal Solution 5mg/mL Compared With Saline Solution in the Relief of Nasal Obstruction.

Sixty subjects will take part in this study. The subjects will be randomly assigned in a 1:1 ratio between the two arms of study. (Group A: Solution of Luffa Nasal Operculate 5mg/mL, Group B: saline).

The subjects will use the study medication or comparative, according to their randomization, for a treatment period of 3 to 7 days. A follow-up visit will be made 15 days after initiation of treatment.

Study Overview

• Status: Unknown
• Conditions: Sinusitis; Rhinitis
• Intervention / Treatment: Drug: Luffa Operculate Nasal Solution 5mg/mL; Drug: Saline Solution (NaCl 0,9%)

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04039-032
    • Universidade Federal de São Paulo/Hospital São Paulo/Escola Paulista de Medicina/UNIFESP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects of both sexes aged over 18 years.
• Presence of nasal congestion due to colds, rhinitis, influenza, sinusitis and acute or chronic sinusitis
• Sign the Informed Consent Form
• Comply the study requirements and attend to study visits
• Female subjects must have a NEGATIVE urine pregnancy test during the screening.

Exclusion Criteria:

• Known allergy to any study product component
• Subject pregnant, lactating or of childbearing potential and not using adequate and effective contraceptive
• Vasoconstrictor nasal topic or oral
• Use of a decongestant nasal whatever the route of administration
• Use of intranasal corticosteroids
• Use of antiallergic
• Use of medication containing atropine
• Subjects that are participating in another study or who participated in another study, less than 12 months
• Any subjects deemed unsuitable for study by the Principal Investigator
• Abuse of alcohol or illicit drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Luffa Operculate Nasal Solution 5mg/mL; The treatment will start on the first visit in which subjects will be instructed to instill in the nasal passages, 3 drops of the product by morning and 3 drops of the product at night.	Drug: Luffa Operculate Nasal Solution 5mg/mL; The treatment will start on the first visit in which subjects will be instructed to instill in the nasal passages, 3 drops of the product by morning and 3 drops of the product at night.
Active Comparator: Saline Solution (NaCl 0,9%); The treatment will start on the first visit in which subjects will be instructed to instill in the nasal passages, 3 drops of the product by morning and 3 drops of the product at night.	Drug: Saline Solution (NaCl 0,9%); The treatment will start on the first visit in which subjects will be instructed to instill in the nasal passages, 3 drops of the product by morning and 3 drops of the product at night.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of nasal congestion	If the patient present a improvement of nasal congestion 3 days after the treatment start, the treatment will be discontinued and the patient will perfomr the Visit 2.	3 days

Collaborators and Investigators

• Sponsor: Zurita Laboratorio Farmaceutico Ltda.
• Investigators: Principal Investigator: Luis Gregório, doctor's, Universidade Federal de São Paulo/Hospital São Paulo/Escola Paulista de Medicina/UNIFESP

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): July 1, 2011
• Study Completion (Anticipated): July 1, 2011

Study Registration Dates

• First Submitted: November 23, 2010
• First Submitted That Met QC Criteria: November 23, 2010
• First Posted (Estimate): November 25, 2010

Study Record Updates

• Last Update Posted (Estimate): November 25, 2010
• Last Update Submitted That Met QC Criteria: November 23, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Respiratory Insufficiency; Airway Obstruction; Sinusitis; Rhinitis; Nasal Obstruction; Pharmaceutical Solutions
• Other Study ID Numbers: ZUR-LO-2009