A randomised, single blind, placebo-controlled 5-way crossover trial of single doses of intranasal GSK256066 in subjects with seasonal allergic rhinitis (SAR)

• Conditions: Seasonal Allergic Rhinitis; MedDRA version: 9.1Level: LLTClassification code 10039776Term: Seasonal allergic rhinitis

• Registration Number: EUCTR2006-006710-15-DE
• Lead Sponsor: GlaxoSmithKline Research & Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

1. The subject is healthy. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family), physical examination, laboratory studies, and other tests.
2. They are aged 18 to 50 years inclusive.
3. Body mass index less than 29.0 kg/m² with weight range of 55.0kg (females 50kg) to 95.0kg inclusive.
4. They have a history of seasonal allergic rhinitis (repeated yearly episodes).
5. They have a positive skin prick test for grass pollen at or within the 12 months preceding the screening visit.
6. They have a positive RAST for grass pollen at or within the 12 months preceding the screening visit.
7. They are current non-smokers who have not used any tobacco products in the 6 months preceding the screening visit with a pack history of £ 10 pack years.
8. They must have a baseline FEV1>80% predicted and a baseline FEV1(maximum recorded value)/FVC(maximum recorded value)>70% predicted.
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. Pregnant or nursing females.
2. Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception, from at least two weeks prior to the first dose of study medication; and to continue until the final pregnancy test has been performed.
3. On examination the subject is found to have any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or recent (within 2 weeks) or ongoing upper respiratory tract infection which in the Responsible Physician’s opinion renders the subject unsuitable for participation in the study.
4. Any respiratory disease other than mild stable asthma that is controlled with occasional use of as-needed short-acting beta-agonists and associated with normal lung function.
5. The subject has a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
6. The subject has participated in a study with a new molecular entity during the previous 4 months or in any clinical study in the previous 3 months
7. The subject is concurrently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device.
8. The subject has a screening QTc value >450msec, PR interval outside the range 120 to 240msec or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T-wave). In addition subjects will be excluded if they have a history of atrial and ventricular arrhythmia.
9. The subject has a supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening. Also excluded if the subject has a supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
10. The subject has donated a unit of blood (450mL) within the previous 3 months or intends to donate within 3 months of completing the study.
11. The subject is currently taking regular (or a course of) medication whether prescribed or not, including steroids, vitamins, and herbal remedies (e.g. St. John’s Wort). Paracetamol and occasional as needed use of short-acting beta agonists is permitted.

Study & Design

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