E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Seasonal allergic rhinitis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039776 |
E.1.2 | Term | Seasonal allergic rhinitis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate effect of repeat intranasal doses of azelastine hydrochloride alone vs. GSK256066 + azelastine hydrochloride on nasal symptoms of allergic rhinitis provoked by spending 4h in the Vienna Challenge Chamber. |
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E.2.2 | Secondary objectives of the trial |
To explore effects of repeat doses of azelastine hydrochloride alone vs. GSK256066 + azelastine hydrochloride on eye and global symptoms, nasal obstruction and secretions in allergic rhinitis provoked by spending 4h in the Vienna Challenge Chamber.
To explore the safety and tolerability of repeat doses of GSK256066 in combination with azelastine hydrochloride in mild to moderate allergic rhinitic subjects. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Weighted mean total nasal symptom score (sneeze, itch, rhinorrhoea and obstruction) 1-4h post morning dose period spent in the Vienna Challenge Chamber on Day 8. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |