Status:
COMPLETED
Effectiveness of Two Preparations of Loratadine + Pseudoephedrine in Patients With Perennial Allergic Rhinitis.
Lead Sponsor:
Azidus Brasil
Collaborating Sponsors:
EMS S/A
Conditions:
Perennial Allergic Rhinitis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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 ...
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 nos...
Eligibility Criteria
Inclusion
- Comply with all the purposes and procedures of the study by signing and dating the IC own free will. In the case of minors, the document should be signed and dated by the parent or legal guardian;
- Have age over 12 years, regardless of gender, ethnicity or social class;
- Present clinical status of perennial allergic rhinitis from mild to moderate;
- Present clinical status with at least 12 months of evolution;
- Submit the examination of IgE elevation (above 100KU / L).
Exclusion
- Have participated in any experimental study or have taken any experimental drug in the 12 months preceding the start of the study;
- Pregnant or lactating women;
- Have made use of:
- Intranasal or systemic corticosteroids in the month before inclusion;
- Intranasal cromolyn in the two weeks preceding inclusion;
- Intranasal or systemic decongestants in the 03 days preceding inclusion;
- Intranasal antihistamines or systemic in the 03 days preceding the survey;
- Loratadine in the 10 days preceding the survey.
- have any disease or anatomical abnormality in the upper airways which could jeopardize the analysis of data, for example, tumors or severe septal deviations;
- History of smoking in the 03 months preceding the inclusion;
- History of alcohol or illicit drugs;
- History of liver disease or kidney disease;
- Electric current asthma or gift last year;
- Table of uncontrolled hypertension;
- Patients with heart disease or who use drugs for the cardiovascular system that is suffering interference of the drugs studied, for example, β-blockers;
- Patients with flu-like symptoms or fever of unknown origin, defined current or within last 07 days;
- Clinical diagnosis of rhinitis is not that kind of allergic and perennial;
- Be patient with sensitivity to loratadine, pseudoephedrine sulfate, or any components of the formula;
- Estimated travel or displacement of the southeast for more than 50% of monitoring.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT01228630
Start Date
August 1 2011
End Date
May 1 2012
Last Update
April 11 2016
Active Locations (1)
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1
Lal Clínica Pesquisa E Desenvolvimento Ltda
Valinhos, São Paulo, Brazil, 13270-245