E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Allergic rhinitis with symptoms like runny nose, sneezing, nasal itching and congestion. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039085 |
E.1.2 | Term | Rhinitis allergic |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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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 |
Evaluation of the efficacy and safety of a new nasal spray with the active ingredient mometasone furoate vs. the originator Nasonex® vs. vehicle in patients with allergic rhinitis.
See also E5 (endpoints). |
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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. Patients must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
2. Patients of either sex, of any ethnic origin, 18 years of age or older.
3. Diagnosis of persistent allergic rhinitis: symptoms > 4 days/ week and > 4 consecutive weeks.
4. Positive allergic sensitivity testing within 2 years prior to study start or at the screening visit
5. The patient is clinically symptomatic at day -7 and has the following Total Nasal Symptom Scores (TNSS) as assessed jointly by the subject and the investigator: Total instantaneous TNSS (iTNSS) ≥ 6 and nasal congestion score ≥ 2 and one of the other 3 symptoms ≥ 2.
6. For women of childbearing potential: Pregnancy test with negative result at screening examination
7. Women of childbearing potential can either be surgically sterile (hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intrauterine device (IUD), condom with intravaginal spermicide or should be sexually abstinent.
In addition to these criteria minimal TNSS scores at study day 0 qualify for randomization. The daily rTNSS scores day -7 to day -1 (patient diary entries) are decisive: Total rTNSS ≥ 42 and nasal congestion scores ≥ 14 and one of the other 3 symptom scores ≥ 14
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E.4 | Principal exclusion criteria |
1. Hypersensitivity to mometasone furoate or to another ingredient of the investigational products.
2. Current viral or bacterial nasal infections.
3. Patients after nasal surgery or injury within 6 months prior to screening.
4. Patients with active or quiescent tuberculous infections of the respiratory tract or patients with fungal, bacterial, systemic viral infections or ocular herpes simplex.
5. Patients with evidence of nasal polyps, deviated septum, or other intranasal anatomical obstructions that would interfere with nasal air flow.
6. Acute or chronic sinusitis.
7. Acute respiratory infections within 2 weeks prior to screening.
8. Nasal decongestants within 3 days prior to screening or habitual use of decongestants.
9. Nasal or ocular Glucocorticoids within 1 week prior to screening.
10. Systemic antihistaminic medication within 1 week prior to screening.
11. Antibiotic therapy within 2 weeks prior to screening due to upper respiratory tract or sinus infection.
12. Inhaled, oral, or intravenous Glucocorticoids within 1 month prior to screening.
13. Immunosuppressive medication 1 month prior to screening.
14. Intramuscular Glucocorticoids or antibodies within 3 months prior to screening.
15. Current immunotherapy (hyposensitization) and immunotherapy within 2 years prior to screening.
16. Pregnancy or lactation.
17. Patients with other significant diseases (including asthma) that, in the investigator’s judgment, may interfere with the study evaluation or affect subject safety.
18. History of alcohol and/or drug and/or substance abuse, especially abuse of substances affecting the nasal mucosa.
19. Dependency upon decongestants.
20. Participation in another clinical study within 30 days prior to screening or former participation in this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
TNSS change from baseline (begin of therapy – end of therapy):
The Total Nasal Symptom Score (TNSS) will be used as the primary efficacy criterion in this study. Change from baseline (begin of therapy - end of therapy) will be calculated in absolute units: Daily reflective TNSS (rTNSS) on one day prior to treatment start minus daily rTNSS on one day prior to end of treatment visit. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
One day prior to treatment start (study day -1) and one day prior to end of treatment visit (study day 41). |
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E.5.2 | Secondary end point(s) |
- Change (begin of therapy - end of therapy) of the rTNSS in the morning (AM rTNSS)
- Change (begin of therapy - end of therapy) of the rTNSS in the evening (PM rTNSS)
- Course of the daily rTNSS over the entire treatment period
- Course of instantaneous TNSS (iTNSS) over the entire treatment period
- Global evaluation of therapeutic efficacy on a 5 point scale (0=cured, 1=clear improvement, 2=moderate improvement, 3=no change, 4=worsened) by patient and physician at the end of treatment visit |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Different, depending on the end point, see E.5.2 |
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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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |