E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Seasonal Allergic Rhinitis (SAR) |
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MedDRA Classification |
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 the consistency of the results obtained from the Vienna Chamber Challenge (VCC) and the Park Study trial models using repeat intranasal doses of fluticasone propionate vs. placebo on allergic symptoms of SAR provoked by spending 5 hours in the VCC in and out of season versus 5 hours in the Park Study in season. |
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E.2.2 | Secondary objectives of the trial |
• To investigate the clinical efficacy of repeat intranasal doses of fluticasone propionate vs. placebo on subjective nasal, eye and global symptoms, and objective nasal flow and nasal secretions in provoked allergic rhinitis, after spending 5 hours in the VCC in and out of season versus 5 hours in the Park Study in season.
• To investigate the safety and tolerability of repeat doses of fluticasone propionate.
• To investigate the effect of fluticasone propionate treatment on quality of life (QoL) in subjects with SAR.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. The subject is healthy (male or female). 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. Healthy subjects with allergic rhinitis may also have mild stable asthma i.e. they only require occasional as needed use of short-acting beta agonists.
2. They are aged 18 to 50 years.
3. They have a history of seasonal allergic rhinitis
4. Exhibit a moderate response to 1500 grass pollen grains/m3 after 2 hours in the Vienna Challenge Chamber at screening or within 12 months preceding the screening visit. A moderate response is defined as a total nasal symptom score of at least 6. (Total nasal symptom score is the sum of obstruction, rhinorrhoea, itch and sneeze, each of which has been scored on a scale from 0 to 3).
5. They have a positive skin prick test (wheal > or = 4mm) for grass pollen at or within the 12 months preceding the screening visit.
6. They have a positive RAST (> or = class 2) for grass pollen at or within the 12 months preceding the screening visit.
7. They have demonstrated an ability to use the intranasal spray
8. There are no conditions or factors which would make the subject unlikely to be able to stay in the chamber for 5hours.
9. They are capable of giving informed consent which includes compliance with the requirements and restrictions listed in the consent form
10. They are available to complete all study measurements
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E.4 | Principal exclusion criteria |
A subject will not be eligible for inclusion in this study if any of the following criteria apply: 1. Pregnant or nursing females.
2. Female subjects of childbearing potential who are unwilling or unable to use an appropriate method of contraception [i.e. implants of levonorgestrel, injectable progesterone, an acceptable IUD (any IUD with a failure rate of less than 1% per year), oral contraceptives ] for at least two weeks prior to the first dose of study medication and should continue using the same contraceptive measure until the final pregnancy test has been performed (not less than 72 hours after treatment). Alternatively they may be surgically sterilised (refer to section 6.4) or remain abstinent for 2 weeks before exposure to study drug.
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 3 weeks) or ongoing upper respiratory tract infection which in the responsible physician’s opinion renders the subject unsuitable for participation in the study
4. The subject has 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 history of drug or other allergy that, in the opinion of the responsible physician, contraindicates their participation.
7. The subject has participated in a study with a new molecular entity during the previous 3 months or in any clinical study in the previous 2 months
8. 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.
9. 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
10. The subject regularly, or on average, drinks more than 3 units of alcohol per day - where 1 unit = ½ pint of beer (284mL), or 1 glass of wine (125mL), or 1 measure of spirit (25mL).
11. The subject is at risk of non-compliance with the study procedures/restrictions
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E.5 End points |
E.5.1 | Primary end point(s) |
Weighted mean major symptom complex (MSC) sneeze, nasal itch, rhinorrhoea and itching eyes following 5 hours spent in the VCC, in and out of season, and 5 hours in the Park Study in season. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Validation of trial models |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | 6 |
E.8.9.1 | In the Member State concerned days | |
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 | 6 |