E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Seasonal Allergic Rhinitis |
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E.1.1.1 | Medical condition in easily understood language |
Seasonal Allergic Rhinitis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
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 primary objective of this study was to assess the efficacy of mometasone furoate nasal spray (MFNS) once daily compared with placebo in subjects with seasonal allergic rhinitis (SAR) in reducing the total nasal symptom score (TNSS) and the total ocular symptom score (TOSS). |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study were to assess the efficacy of MFNS in improving nasal congestion, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) total score, and AM peak nasal inspiratory flow (PNIF). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. A subject must have been 12 years of age or older, of either sex, and of any race.
2. A subject must have had at least a 2-year documented history of SAR which exacerbated during the study season.
3. A subject must have had a positive skin prick test response to an appropriate seasonal allergen at the Screening Visit. IgE-mediated hypersensitivity to an appropriate seasonal allergen (ie, prevailing trees and/or grasses) must have been documented by a positive response to the skin prick test with wheal diameter at least 3 mm larger than diluent control after 20 minutes.
4. A subject must have been clinically symptomatic at the Screening Visit (assessed by the subject): nasal rhinorrhea must have been ≥2, nasal congestion must have been ≥2, TNSS must have been ≥6, TOSS must have been ≥4, and an overall evaluation of SAR must have been ≥2.
5. A subject must have been clinically symptomatic at the Baseline Visit. The total of the seven run-in diary reflective (PRIOR) scores for the 3 days prior to Baseline and the AM of the Baseline visit must have been: rhinorrhea score ≥14, nasal congestion score ≥14, TNSS ≥42, and TOSS ≥28.
6. A subject must have been in general good health as confirmed by routine clinical and laboratory testing. All laboratory tests must have been within normal limits or clinically acceptable to the investigator and sponsor.
7. A subject must have been free of any clinically significant disease, other than SAR, which would have interfered with the study evaluations.
8. A subject and/or parent/guardian must have been willing to give written informed consent and must have been able to adhere to dosing and visit schedules and met study requirements.
9. A female subject of childbearing potential must have had a negative serum pregnancy test (HCG) at Screening. Nonsterile and premenopausal female subjects must have been using a medically acceptable method of birth control, ie, double barrier method, oral contraceptive, hormonal implant, or depot injectable prior to Screening and during the study. |
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E.4 | Principal exclusion criteria |
1. A subject whose ability to provide informed consent was compromised.
2. A subject with a history of noncompliance with medications or treatment protocols.
3. A subject with a history of anaphylaxis and/or other severe local reaction(s) to skin testing.
4. A subject with significant medical condition(s) that, in the judgment of the investigator, might have interfered with the study or required treatment.
5. A subject who had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who had a viral upper respiratory infection within
7 days prior to the Screening Visit.
6. A subject who had used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
7. Pregnant or nursing females. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The co-primary efficacy endpoints were the change from Baseline in average AM instantaneous (NOW) TNSS and TOSS over Days 2 to 15. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Throughout the study, the severity of symptoms of allergic rhinitis was to be individually scored twice daily by the subject and was to be based on the subject’s status over the previous 12 hours (reflective or PRIOR) and on the subject’s status at the time of evaluation (instantaneous or NOW). |
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E.5.2 | Secondary end point(s) |
•The change from Baseline in AM NOW nasal congestion score averaged over Days 2 to 15.
•The change from Baseline in RQLQ total score at Endpoint.
•The change from Baseline in AM peak nasal inspiratory flow (PNIF) averaged over Days 2 to 15.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Throughout the study, the severity of symptoms of allergic rhinitis was to be individually scored twice daily by the subject and was to be based on the subject’s status over the previous 12 hours (reflective or PRIOR) and on the subject’s status at the time of evaluation (instantaneous or NOW). |
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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 | 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 | 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 | 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 | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |