Effects of treated and untreated Allergic Rhinitis on Mood, Cognitive functions and Actual Driving Performance - Rhinitis and Driving

Phase 1

• Conditions: Seasonal Allergic Rhinitis; MedDRA version: 12.1Level: LLTClassification code 10039776Term: Seasonal allergic rhinitis

• Registration Number: EUCTR2010-021933-30-NL
• Lead Sponsor: Maastricht University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-27
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.All patients must be normal healthy males or females, age between 21 and 45 years, diagnosed with seasonal AR (SAR), also known as Intermittent Rhinitis (ITR); Anti-allergic treatment during the previous season, positive radioallergosorbent test for serum-specific immunoglobulin E or positive skin prick test for tree/ and/or grass- and/or weed pollen. The severity of nasal symptoms (itching, secretion, sneezing and congestion) is rated by the Allergy Symptom Check List (ASCL, Kremer et al 2002); before a nasal challenge is performed patients should score less than four.
2.Patients must be experienced drivers. That is, each shall have held a driver’s license for at least the preceding two years and shall have driven more than 5,000 km/yr (3,000 miles/yr) during that period.
3.Patients must be in general good health as confirmed by routine clinical and laboratory testing. Clinical laboratory tests ( CBC, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the Investigator/`medical supervisor.
4.Patients must have a negative urine screen at Screening for drugs with a high potential for abuse.
5.Patients must be free of any clinically significant disease, which would interfere with the study evaluations.
6.Patients must be willing to give written informed consent and must be able to adhere to dosing and visit schedules and meet study requirements.
7.Patients must be able to communicate, participate, and comply with the requirements of the entire study, including completion of all visits.
8.In females of childbearing potential, the serum pregnancy test (HCG) must be negative at the Screening Visit.
9.Weight: within 10% of normal average for the individual’s sex, age and height.
10.Vision: normal binocular acuity, corrected, or uncorrected.

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients who have clinically significant abnormal physical findings or vital signs at the Screening physical examination (as determined by the Investigator) which could interfere with the objectives of the study. This includes patients who have any history or symptoms of chronic illness, history of psychotic disorders, drug addiction or abuse of drugs or alcohol, or impaired mentation which could interfere with the completion of the study.
2.Patients requiring any CNS medication during the study, or medication with sedative effects which could interfere with the objectives of the study.
3.Patients who have taken participated in an investigational drug trial within one month prior to the Screening Visit.
4.Patients with a history of allergies to more than two classes of medication or who are allergic to or cannot tolerate antihistamines.
5.Excessive smoking; i.e., more than ten cigarettes per day or the equivalent.
6.Excessive consumption of beverages containing caffeine; i.e., more than five cups per day.
7.Patients with active seasonal and/ or perennial allergic rhinitis.
8.Pregnant or nursing females.
9.The investigational study staff who is involved with this study.
10.Patients previously randomized into the study.
11.Patients who have taken a sedative/hypnotic, antihistaminic or anticholinergic drug during the two weeks prior to entering the study.

Study & Design

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