A randomised, double blind, 2-way crossover trial of 8 days repeat dosing with intranasal GSK256066 and azelastine hydrochloride 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: EUCTR2007-005302-44-AT
• Lead Sponsor: GlaxoSmithKline Research & Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. The subject is healthy.
2. Male or female between 18 and 50 years inclusive.
3. A female subject is eligible to participate if she is of:
• Non-childbearing potential defined as pre-menopausal females with a
documented tubal ligation or hysterectomy; or postmenopausal defined as 12
months of spontaneous amenorrhea.
• Child-bearing potential and agrees to use one of the contraception methods
listed in Section 8.1 for an appropriate period of time (as determined by the
product label or investigator) prior to the start of dosing to sufficiently minimize
the risk of pregnancy at that point. Female subjects must agree to use
contraception until the end of the study.
4. Body mass index less than 29.0 kg/m² with weight range of 55.0kg (females
50kg) to 95.0kg inclusive.
5. The subject has a history of seasonal allergic rhinitis.
6. The subject exhibits a moderate response to 1500 grass pollen grains/m3 after 2
hours in the Vienna Challenge Chamber, defined as a nasal symptom score of at
least 6.
7. The subject has a positive skin prick test (wheal = 4mm) for grass pollen at or
within the 12 months preceding the screening visit.
8. The subject has a positive RAST (= class 2) for grass pollen at or within the 12
months preceding the screening visit.
9. The subject is a current non-smoker who has not used any tobacco products in
the 6 months preceding the screening visit with a pack history of = 10 pack years.
10. The subject 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.
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 has donated a unit of blood (450mL) within the previous 3 months or
intends to donate within 3 months of completing the study.
10. The subject has used oral, injectable or dermal steroids within 5 weeks or
intranasal and/or inhaled steroids within 1 week of the screening visit.
11. The subject has an elevated Troponin T above the normal range.
20. The subject, as deemed by the Investigator has a clinically significant CK-MB
value above the normal range.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate effect of repeat intranasal doses of azelastine hydrochloride alone vs.<br>GSK256066 + azelastine hydrochloride on nasal symptoms of allergic rhinitis provoked by spending 4h in the Vienna Challenge Chamber.;Primary end point(s): Weighted mean total nasal symptom score (sneeze, itch, rhinorrhoea and<br>obstruction) 1-4h post morning dose period spent in the Vienna Challenge Chamber<br>on Day 8.;Secondary Objective: To explore effects of repeat doses of azelastine hydrochloride alone vs. GSK256066 + azelastine hydrochloride on eye and global symptoms, nasal obstruction and<br>secretions in allergic rhinitis provoked by spending 4h in the Vienna Challenge<br>Chamber.<br><br>To explore the safety and tolerability of repeat doses of GSK256066 in combination<br>with azelastine hydrochloride in mild to moderate allergic rhinitic subjects.