None listed
Conditions
Interventions
Subjects will receive 5 mg of Desloratadine per day for 14 days
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: • Subjects must demonstrate their willingness to participate in the study and obey the procedures by signing a written informed consent. • The subjects must be greater than or equal to 18-60 years of age, of any sex and of any race. • Women who could potentially become pregnant (includes women who are less than 1 year post-menopausal and women who are sexually active) should be using a contraception method (eg, hormonal contraction, medically prescribed IUD, condoms in combination with spermicides) ) or be surgically sterilized (for example, hysterectomy or tubal ligation). Women with the potential to become pregnant should be advised to use one of the methods mentioned in this study. Women who are not sexually active must agree to and consent to the use of one of the above methods if they decide to become sexually active while participating in the study. • Subjects must have good general health; that is, they must be free of any clinically significant disease (other than RAP) that could interfere with the study´s assessments. • Subjects must understand and be able to adhere to the medication and schedule of consultation, and agree to record the severity of symptoms, concomitant medications, and adverse effects accurately and consistently in a weekly newspaper, and complete the weekly questionnaires. • Subjects must have at least a two-year history of perennial allergic rhinitis documented in their medical record. • Subjects must be clinically symptomatic with RAP in Consultation 2 (baseline); The total RAP symptom score must be greater than or equal to 5 (out of a possible 15) with a nasal congestion score greater than or equal to 2 • Women with potential risk of maternity should have a negative pregnancy test in Consulta 2 (baseline).
Exclusion criteria
Exclusion criteria: • Women who are pregnant or nursing. • Subjects who have not observed periods of non-use for any of the prohibited medications designated in Section 6.2, • Subjects with asthma that require the chronic inhaled or systemic use of corticosteroids. • Subjects with frequent or current history of sinusitis, clinically significant or post-nasal purulent chronic discharge. • Subjects with rhinitis medicamentosa. • Subjects who have had upper respiratory tract or sinus infection and who required antibiotic therapy 14 days prior to Consultation 1 (Screening), or subjects who have had a viral infection of the upper respiratory tract 7 days prior to Consultation 1 . • Subjects that have nasal structural abnormalities, including nasal polyps and a marked septal deviation, that significantly interfere with nasal airflow. • Subjects who, in the opinion of the Investigator, are dependent on nasal, oral or ocular decongestants, topical nasal antihistamines, or nasal steroids. • Subjects with a history of hypersensitivity to desloratadine or any of its excipients. • Subjects that are part of the personnel directly involved with the administration of this study. • Subjects who have any clinically significant metabolic, cardiovascular, immunological, neurological, hematological, gastrointestinal, cerebrovascular, or respiratory disease, or any other disorder that, in the Investigator´s judgment, may interfere with the study´s assessments or may affect the safety of the subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation of signs and symptoms Measure:The correlation of the severity of RAP symptoms with quality of life. Timepoints:After treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The basal change in the Mini RQLQ global (Mini Juniper) and in the scoring domain after 7 (day 8) and 14 (day 15) days of treatment. Measure:The basal change in the Mini RQLQ global (Mini Juniper) and in the scoring domain after 7 (day 8) and 14 (day 15) days of treatment. Timepoints:day 8 and day 15 ; Outcome name:Basal change the score on the severity of RAP symptoms after 7 (day 8) and 14 (day 15) days of treatment. Measure:Basal change the score on the severity of RAP symptoms after 7 (day 8) and 14 (day 15) days of treatment. Timepoints:day 6 and day 15 ; Outcome name:The frequency of the report of co-existence of respiratory tract disease and severity of baseline symptoms during the study. Measure:The frequency of the report of co-existence of respiratory tract disease and severity of baseline symptoms during the study. Timepoints:day 8 and day 15 | — |
Outcome results
None listed