Study to Evaluate the Effect of the Coadministration of SCH 497079 (a Histamine 3 [H3] Receptor Antagonist) Plus Desloratadine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis Who Have Been Exposed to Pollen in the Vienna Challenge Chamber (VCC) - H3 POC

Phase 1

• Conditions: Seasonal Allergic Rhinitis; MedDRA version: 7.0 Level: LLT Classification code 10039776

• Registration Number: EUCTR2004-001883-39-AT
• Lead Sponsor: Schering Plough Reserach Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-12-29
• Study Completion: 2005-01-14
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

1.Subjects must be willing to give written informed consent and adhere to dose and visit schedules.
2.Subjects must have the appropriate washout times from the prohibited medications (see Section 7.4.2.1.1).
3.Clinical laboratory tests (CBC, blood chemistries, urinalysis) at screening must be within normal limits or clinically acceptable to the investigator.
4.Subjects must skin test positive confirming hypersensitivity to Dactylis glomerata grass allergen extract which is cross reactive with pollen mixture used in the chamber, unless a positive test was obtained within the previous 12 months. IgE-mediated hypersensitivity must be documented by a positive response to the skin prick test with wheal diameter ?3 mm larger than diluent control.
5.Female subjects of childbearing potential must have a negative serum pregnancy test prior to treatment with study medication; a negative urine pregnancy test must be obtained at least every 28 days during study participation. Female subjects of childbearing potential must be using a medically accepted method of birth control (eg, double barrier method, oral contraceptive, Depo-Provera, or Norplant) prior to Screening and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy or tubal ligation). Women of childbearing potential should be counseled in the appropriate use of birth control while in this study. Women who are not currently sexually active must agree and consent to use one of the medically accepted methods of birth control if they become sexually active while participating in the study.
6.Subjects must have the following minimum symptom scores using a 0-3 scale at some point during each of the 120-minute screening period challenge sessions:
a.Nasal Congestion Score of at least 2;
b.Total Nasal Symptoms Score of at least 6 (symptoms are nasal congestion, nasal itching, sneezing, and rhinorrhea);
c.Total Non-nasal Symptoms Score of at least 2 (symptoms are itching/burning eyes, tearing/watering eyes, and itching of ears/palate.
7.Subjects must be in good health and free of any clinically significant disease (other than SAR) that would interfere with the study schedule or procedures, or compromise the subject’s safety.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Female subjects who are pregnant, intend to become pregnant during the study, or are nursing.
2.Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
3.Subjects who have used any investigational drugs, including placebo, within 30 days of study entry.
4.Subjects who are participating in any other clinical study.
5.Subjects who are part of the staff personnel directly involved with this study.
6.Subjects who are family members of the investigational study staff directly involved with this study.
7.Subjects who had an upper or lower respiratory tract infection within 4 weeks before screening, or who have a respiratory infection any time during the treatment phase of the study.
8.Subjects who have nasal structural abnormalities, including large nasal polyps or marked septal deviation, that significantly interfere with nasal airflow.
9.Subjects who have been previously enrolled (ie, signed informed consent) into this study.
10.Subjects with rhinitis medicamentosa.
11.Subjects with a history of anaphylaxis or severe or serious reaction to skin testing.
12.Subjects who have a known potential for hypersensitivity, allergy, or idiosyncratic reaction to any of the study drugs or excipients.
13.Subjects who, in the opinion of the investigator, are dependent upon nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified