E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Rhinitis, Allergic, Perennial |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
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 compare the efficacy and safety of Fluticasone Furoate Nasal Spray 110μg once daily with vehicle placebo nasal spray for 2 weeks in Chinese adult and adolescent subjects with Allergic Rhinitis |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1, Chinese adolescent and adult (male or eligible female) outpatients with the age of >=12 years
2, Confirmative diagnosis of IAR or PER (as definitions from ARIA 2008 and the coming effective Chinese AR management guideline ), by medical history, symptoms, skin prick tests (SPTs)
3, Subject must be symptomatic at screening and willing to maintain same environment throughout the study
4, Ability to comply with study procedures
5, Literate
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E.4 | Principal exclusion criteria |
1. Having complications of nasal disease, or vasomotor rhinitis, rhinitis with eosinophilia, or drug rhinitis
2. Having complications of bacterial/viral infection of upper respiratory tract
3. Having significant systemic diseases
4. History of hypersensitivity to steroids and ingredients
5. Pregnant women or under lactation
6. Patients who started, discontinued or changed dose of desensitization therapy within 30 days before visit 1
7. Patients planning to travel outside the region
8. Patients judged to be inappropriate by investigators
9. Patients who participated in another study within 4 months before screening
10. Patients who could not withdraw drugs during screening period or secure withdrawal period until the initiation day of administration, e.g.
a) allergy medications
b) other medications that may affect allergic rhinitis or its symptoms
c) any medications that significantly inhibit CYP3A4, including ritonavir and ketoconazole |
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E.5 End points |
E.5.1 | Primary end point(s) |
The mean change from baseline over the entire treatment period in daily, reflective, total nasal symptom score (rTNSS) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- At completion of study treatment, the mean change from baseline in severity of overall inference in activities of dairy living
- At completion of study treatment, mean change from baseline in nasal finding scores by rhinoscopy
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
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 | Yes |
E.8.1.6 | Cross over | No |
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.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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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.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |