An 8 day, randomised, double blind, 3-way crossover trial of repeat doses of intranasal GSK256066 and fluticasone propionate in the Vienna Challenge Chamber in subjects with seasonal allergic rhinitis (SAR)

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

• Registration Number: EUCTR2007-005301-22-AT
• Lead Sponsor: GlaxoSmithKline Research & Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

1. The subject is healthy.
2. They 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.
5. They exhibit a moderate response to 1500 grass pollen grains/m3 after 2h in the
Vienna Challenge Chamber, which is defined as a nasal symptom score of at least
6. They have a positive skin prick test (wheal = 4mm) for grass pollen at or within
the 12 months preceding the screening visit.
7. They have a positive RAST (= class 2) for grass pollen at or within the 12 months
preceding the screening visit.
8. 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.
9. They must have a baseline FEV1>80% predicted and a baseline FEV1 (maximum
recorded value)/FVC (maximum recorded value)>70% predicted.
10. They are capable of giving informed consent which includes compliance with the
requirements and restrictions listed in the consent form.
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.
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
or ongoing upper respiratory tract infection.
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 is likely to be unable to abstain from salbutamol use for 8 hours
before a challenge.
6. The subject has a screening QTc(B) value >450msec, PQ interval outside the range
120 to 240msec or an ECG that is not suitable for QT measurements. In addition
subjects will be excluded if they have a history of atrial and ventricular arrhythmia.
7. A supine blood pressure that is persistently higher than 140/90 millimetres of
mercury (mmHg) at screening.
8. A supine mean heart rate outside the range 40-90 beats per minute (bpm) at
screening.
9. The subject had used oral, injectable or dermal steroids within 5 weeks or
intranasal and/or inhaled steroids within 1 week of the screening visit.

Study & Design

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