NCT01228630

Effectiveness of Two Preparations of Loratadine + Pseudoephedrine in Patients With Perennial Allergic Rhinitis.

Randomized Clinical Study for Efficacy Assessment Between Cloratadd-D, Loratadine + Pseudoephedrine (Coated Pill), Produced by EMS S/A Laboratories and Allegra-D , Produced by Sanofi-Aventis for Patients With Perennial Allergic Rhinitis.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Azidus Brasil · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The loratadine-pseudoephedrine combination has proven to be more effective than the use of these individual components. This prospective, randomized, double-blind and paralel study, in which patients with perennial allergic rhinitis receive one of loratadine + pseudoephedrine association drug for treatment of signs and symptoms during 4 weeks.

Detailed description

The effectiveness of treatment in each drug group will be evaluate by global improvement of signs (nasal mucous edema, ocular hyperemia, nasal secretion) and symptoms (itching eye, tearing,itching nose, itching on the palate) of perennial allergic rhinitis, after 4 weeks of treatment. Symptoms as rhinorrhea, nasal congestion, itching nose, sneezing and itching eye were considered as secondary efficacy endpoint, along with the questionnaire of quality of life SF-36. Safety evaluation data will include report of all adverse events (including type, frequency, instensity, seriousness, severity and action taken related to investigational product) reported by patients, parents or legal responsible, ou observed by Investigator.

Conditions

• Perennial Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Cloratadd-D	The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water.
DRUG	Allegra-D	The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water.

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-04-01
• Completion: 2012-05-01
• First posted: 2010-10-26
• Last updated: 2016-04-11

Locations

1 site across 1 country: Brazil