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 |
Investigate effect of repeat intranasal doses of fluticasone propionate alone vs. GSK256066 + fluticasone propionate on nasal symptoms of allergic rhinitis |
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E.2.2 | Secondary objectives of the trial |
Explore effects of repeat intranasal doses of fluticasone propionate alone vs. GSK256066 + fluticasone propionate and GSK256066 alone vs. GSK256066 + fluticasone propionate on eye and global symptoms, nasal obstruction and secretions in allergic rhinitis
Explore the safety and tolerability of repeat intranasal doses of GSK256066 and GSK256066 in combination with fluticasone propionate in mild to moderate allergic rhinitic subjects
Explore the effects of GSK256066 and fluticasone propionate on exploratory markers of PDE4 inhibition and glucocorticoid-provoked gene expression, respectively, in nasal lavage and scrape samples 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. 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. |
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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 had used oral, injectable or dermal steroids within 5 weeks or intranasal and/or inhaled steroids within 1 week of the screening visit. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Weighted mean TNSS (sneeze, itch, rhinorrhoea and obstruction) 1 to 4 hours post morning dose period spent in the Vienna Challenge Chamber on Day 2 |
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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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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
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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 | 4 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |