| 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.1.3 | 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:
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).
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)
Reduces the likelihood of interference with sleep and activities of daily living as recorded AM and PM, respectively, by subjects in their diary daily.
Improves nasal airflow as measured AM and PM by a nasal airflow meter.
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 |
1.Subject must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
2.Subject must be 18 years of age and older, of either sex, and of any race.
3.Subject must be clinically symptomatic at the Screening Visit (Day -7 to -4: Visit 2), and must have the following nasal symptoms/signs severity scores (PRIOR-reflective) as assessed jointly by the subject and the investigator or qualified designee:
• nasal stuffiness/congestion ≥ 2
• rhinorrhea/nasal discharge ≥ 2
• sneezing ≥ 1
• nasal itching ≥ 1
• TNSS ≥ 6
The presence and severity of the non-nasal symptoms/signs (eye itching, eye tearing, eye redness, itching of ears and/or palate) will be recorded.
4.Subject must be clinically symptomatic at the Baseline Visit (Day 1: Visit 3). Scores for the seven run-in diary time points prior to and including the AM diary time point on the morning of the Baseline Visit (the three AM evaluations prior to the Baseline Visit, the AM evaluation on the day of or the Baseline Visit, and the three PM evaluations prior to the Baseline Visit) must total the following:
• Nasal stuffiness/congestion ≥ 14
• Rhinorrhea/nasal discharge ≥ 14
• Sneezing score ≥ 7
• Nasal itching score ≥ 7
• TNSS ≥ 42
The presence and severity of the non-nasal symptoms/signs (eye itching, eye tearing, eye redness, itching of ears and/or palate) will be recorded.
5.At the Screening Visit (Day -7 to -4: Visit 2), subject must have complaints of sleep disturbance while symptomatic with seasonal allergic rhinitis and must have a score of 30 or greater for the Sleep Disturbance Sleep Scale (items 1,3,7 and 8).
6.At the Baseline Visit (Day 1: Visit 3), subject must have complaints of sleep disturbance and daytime somnolence while symptomatic with seasonal allergic rhinitis and must have a score of 30 or greater for the Sleep Problems Index II (SLP9) and 30 or greater for the Daytime Somnolence Sleep Scale (items 6, 9, and 11).
7.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 prevalent during the time of this study, such as, trees, grasses, weeds, ragweed, and molds. The skin tests should be performed at the Screening Visit (Day -7 to -4: Visit 2) if not done within 12 months prior to the Screening Visit.
9.Subject must be free of clinically significant disease that would interfere with study evaluations.
10.Female subjects of childbearing potential are required to use a medically accepted method of birth control prior to the Screening Visit (Day -7 to -4: Visit 2) and during the study, or provide documentation of surgical sterilization (eg, hysterectomy, tubal ligation). Females of childbearing potential should be counseled in the appropriate use of birth control while in this study. Females who are not sexually active at study enrollment must consent to the use a medically accepted method of birth control if/when they become sexually active during study participation.
11.Female subjects of childbearing potential must have a negative urine pregnancy test at the time of enrollment at the Baseline Visit (Day 1: Visit 3).
12.Subject must understand and be able to adhere to the dosing and visit schedules, and agree to record symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary.
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| E.4 | Principal exclusion criteria |
The subject will be excluded from entry into the study if ANY of the criteria listed below are met:
1.Subject is a female who is pregnant, intends to become pregnant during the study, or is nursing.
2.Subject is currently taking medications prohibited during the study or has not complied with requirements for the “wash-out” period(s) for medication prohibited during this study.
3.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.
4.Subject has evidence of nasal polyps, deviated septum, or other intranasal anatomical obstruction(s) that would interfere with nasal airflow.
5.Subject has acute or chronic sinusitis currently being treated with antibiotics and/or topical or oral nasal decongestants.
6.Subject has had an acute respiratory infection within 2 weeks of the Screening Visit (Day -7 to -4: Visit 2).
7.Subject has been diagnosed with clinically relevant sleep problems unassociated with allergies (eg, sleep apnea, narcolepsy, frequent nocturnal awakenings due to asthma).
8.Subject has complained (within 12 months of the Screening Visit (Day -7 to -4: Visit 2)) to their health-care provider) of difficulty sleeping or daytime sleepiness while not experiencing allergic rhinitis symptoms, and continue with these complaints.
9.Subject has snoring associated with an enlarged uvula or other upper airway pathology.
10.Subject has had episodes of snoring associated with gasping or choking.
11.Subject has awakened suddenly, on more than 1 occasion during the month preceding the Screening Visit (Day -7 to -4: Visit 2), with a gasping or choking feeling.
12.Subject requires the use of oral appliances at night for the relief of bruxism (teeth gnashing) or temporomandibular joint problems.
13.Subject has a diagnosis of asthma with daytime and nighttime asthma symptoms not controlled by short-acting β-2 adrenoceptor agonists.
14.Subject has a dependence on nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids.
15.Subject is currently undergoing a progressive course of immunotherapy (hyposensitization). Subjects on a regular maintenance schedule prior to the Screening Visit (Day -7 to -4: Visit 2) and wish to remain on this schedule during the study are eligible for study inclusion; however, subjects may not receive hyposensitization treatment within 24 hours prior to any study visit.
16.Subject smokes, or is an ex-smoker who has smoked within the previous 6 months.
17.Subject is a member of the Investigational Study Staff (currently involved with this study) or a member of the staff’s family.
18.Subject has been previously randomized into this study.
19.Subject has a concomitant medical problem that may interfere with participation in the study, eg, repeated migraine episodes, uncontrolled convulsive disorders.
20.Subject has any of the following clinical conditions: Active or quiescent tuberculosis infection of the respiratory tract, untreated fungal, bacterial, systemic viral infections or ocular herpes simplex.
21.Subject has any clinically significant deviation from normal in the physical examination or medical history that, in the investigator’s judgment, may interfere with the study evaluation or affect subject safety.
22.Subject is in a situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
23.Subject is participating in any other clinical study(ies).
24.Subject is allergic to or has a sensitivity to the study drug or its excipients.
25.Subject has a compromised ability to provide informed consent.
26.Subject has a history of non-compliance with medications or treatment protocols.
27.Subject is a night-shift worker or does not have a standard “asleep at night/awake during the day” cycle.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
The primary endpoints for the study are
•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 (MOS-SS) 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 | No |
| 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 | 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) | 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 | |
| E.8.9.1 | In the Member State concerned months | 12 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 12 |
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