E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Symptomatic Seasonal Allergic Rhinitis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039085 |
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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 |
The co-primary objectives of this study are to demonstrate that treatment with mometasone furoate nasal spray is effective in relieving the subjects nasal symptoms of seasonal allergic rhinitis as measured by the mean change from Baseline of the AM-PRIOR-reflective TNSS the sum of nasal congestion/stuffiness, rhinorrhea/nasal discharge, nasal itching, sneezing , and, is effective in the reduction of sleep disturbance and daytime somnolence as measured by the Medical Outcomes Study Sleep Scale MOS-SS . |
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E.2.2 | Secondary objectives of the trial |
To demonstrate that treatment with mometasone furoate nasal spray 1. Improves overall the subjects symptomatic seasonal allergic rhinitis as measured by the subjects global self ratings of perceptible changes in nasal symptoms from Baseline Global Nasal Therapeutic Response, GNTR . 2. Improves overall the subjects sleep disturbances as measured by the subjects global self ratings of perceptible changes in sleep disturbances from Baseline Global Sleep Therapeutic Response, GSTR 3. Reduces the likelihood of interference with sleep and activities of daily living as recorded AM and PM, respectively, by subjects in their diary daily. 4. Improves nasal airflow as measured AM and PM by a nasal airflow meter. 5. Is effective in relieving the subjects non-nasal symptoms of seasonal allergic rhinitis as measured by the mean change from Baseline of the AM-PRIOR-reflective TNNSS e.g., eye itching, eye tearing, eye redness, itching of ears and/or palate . |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Subject must be 18 years of age - Subject must be clinically symptomatic at the Screening Visit Day -7 to -4 Visit 2 , nasal stuffiness/congestion 8805; 2 rhinorrhea/nasal discharge 8805; 2 sneezing 8805; 1 nasal itching 8805; 1 TNSS 8805; 6 - Subject must be clinically symptomatic at the Baseline Visit Day 1 Visit 3 . Nasal stuffiness/congestion 8805; 14 Rhinorrhea/nasal discharge 8805; 14 Sneezing score 8805; 7 Nasal itching score 8805; 7 TNSS 8805; 42 5. At the Screening Visit Day -7 to -4 Visit 2 , subject must have complaints of sleep disturbance - At the Baseline Visit Day 1 Visit 3 , subject must have complaints of sleep disturbance and daytime somnolence - Subject must have a 2-year or longer history of seasonal allergic rhinitis occurring during the same season s as the current study. 8. Subject must have skin tests prick or intradermal positive for outdoor allergens common in subjects with seasonal allergic rhinitis |
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E.4 | Principal exclusion criteria |
- Subject is a female who is pregnant, intends to become pregnant during the study, or is nursing. - Subject is currently taking medications prohibited during the study - Subject has used any investigational product within 30 days prior to enrollment or any antibodies for asthma or allergic rhinitis in the past 90 days. - Subject has evidence of nasal polyps, deviated septum, or other intranasal anatomical obstruction s that would interfere with nasal airflow. - Subject has acute or chronic sinusitis currently being treated with antibiotics and/or topical or oral nasal decongestants. - Subject has had an acute respiratory infection within 2 weeks of the Screening - Subject has been diagnosed with clinically relevant sleep problems unassociated with allergies eg, sleep apnea, narcolepsy, frequent nocturnal awakenings due to asthma . |
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E.5 End points |
E.5.1 | Primary end point(s) |
mean change from the baseline score of the AM-PRIOR-reflective total nasal symptoms severity TNSS score averaged over the last week 7 days of treatment. The total nasal symptoms severity score includes the sum of congestion/stuffiness, rhinorrhea/nasal discharge, sneezing, and nasal itching. mean change from the baseline score of the Sleep Problems Index II SLP9 score from the Medical Outcomes Study Sleep Scale MOSSS at the Day 29 Visit |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | No |
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 | 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.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 |