Last updated: October 27, 2022
Sponsor: Azidus Brasil
Overall Status: Trial Not Available
Phase
3
Condition
Common Cold
Allergies & Asthma
Allergy
Treatment
N/AClinical Study ID
NCT01055756
LOREMS0909
Version 3, Amendment 1
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Accept the Consent Form.
- Age between 18 and 60 years, regardless of sex;
- Agree to return to all evaluations of the study;
- Presenting the allergic symptoms confirmed by physical examination and by laboratorytests (IgE and sensitivity to the mite Dermatophagoides pteronyssinus), which shouldprovide a diagnosis of allergic rhinitis with mild to moderate.
Exclusion
Exclusion Criteria:
- Have participated in any experimental study or have ingested any drug trial in the 12months preceding the start of the study;
- Made use of other medications that interfere with the regular response of the drug inthe 4 weeks preceding the start of the study, such as steroids and antihistamines;
- Be patient with sensitivity loratadine / pseudoephedrine sulfate;
- Have any disease or anatomical abnormality in the upper airways is detrimental to theanalysis of data, for example, tumors or septal deviations moderate and severe
- Demonstrate a history of alcohol abuse, drugs or pharmaceuticals.
- Have consumed alcohol within 48 hours prior to the period of hospitalization;
- Have a history of liver disease or kidney disease;
- Present framework of current asthma or recent (less than 1 year);
- To present the severe pressure of any cause or be on medication for that;
- Smokers or patients who stopped smoking less than 06 months;
- Pregnant or nursing women;
- Patients with heart disease or who use medication for the cardiovascular system thatis suffering interference of the drugs studied, for example, β-blockers;
- Patients using corticosteroids or other medicines that interact with the study drugsas monoamine oxidase;
- Patients with a history of glaucoma, urinary retention, and hyperthyroidism;
- Patients who have undergone facial plastic surgery that the physician's discretion,will interfere with nasal airflow
Study Design
Study Start date:
January 01, 2010
Estimated Completion Date:
June 30, 2010
Study Description
Connect with a study center
LAL Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo 13276245
BrazilSite Not Available

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