E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Perennial Allergic Rhinitis |
|
E.1.1.1 | Medical condition in easily understood language |
Perennial Allergic Rhinitis |
|
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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034382 |
E.1.2 | Term | Perennial allergic rhinitis |
E.1.2 | System Organ Class | 100000004855 |
|
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 purpose of this study is to assess local nasal adverse effects, as well as systemic effects, of PATANASE nasal spray
when compared with Patanase Vehicle, pH 3.7 and Patanase Vehicle, pH 7.0 given BID for 12 months in patients with perennial allergic rhinitis (PAR). |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Normal nasal exam;
2. At least 1 years history of perennial allergic rhinitis;
3. Allergy to perennial allergen documented by allergy testing;
4. Age 12 years and older;
5. Refrain from certain allergy medications during the study;
6. Other protocol-defined inclusion criteria may apply. |
|
E.4 | Principal exclusion criteria |
1. Nasal disorders;
2. Use of substances that affect the nasal septum;
3. Exposure to industrial metal plating solutions;
4. Uncontrolled, severe, or unstable diseases;
5. Hypersensitivity to the study drug or nasal spray components;
6. Relative of site staff with access to the protocol;
7. Participation in another investigational study within 30 days or at the same time as this study;
8. Medical Monitor decision;
9. Previous sinus/nasal surgery and current/previous nasal piercings
10. Other protocol-defined exclusion criteria may apply. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or sooner)
Self-Rated Relief Assessment at Day 30 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline (Day 0), Exit (Month 12 or sooner) |
|
E.5.2 | Secondary end point(s) |
Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner
Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit
Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline (Day 0), Exit (Month 12 or sooner) |
|
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) | 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.8.2.4 | Number of treatment arms in the trial | 3 |
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 |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 12 |