E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039083 |
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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 |
To determine if the study drug ANTIRIN® is at least as effective (non inferiority testing) assessed by TNSS changes after 4 day-therapy as the comparative product NASIC® in the treatment of allergic rhinitis and to compare ANTIRIN® with placebo to prove its efficacy and to compare NASIC® to placebo to prove assay sensitivity. |
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E.2.2 | Secondary objectives of the trial |
To determine the safety and tolerability of ANTIRIN®. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
•allergic rhinitis in last 2 years at least •positive skin test or specific IgE to allergens in the medical history •patients between 18 – 60 years, males and females •informed consent form signed •he patient can be reached by phone
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E.4 | Principal exclusion criteria |
•Asthma, with the exception of mild intermittent asthma •Systemic corticoids taken in last 1 month •Immunotherapy started in less than 1 month prior to the enrollment •antihypertensive drugs that may influence nasal congestion within 7 days prior to inclusion ( beta blockers, ACE inhibitors, alpha adrenergic antagonists i.e. prazosin,) •MAO inhibitors and other drugs with hypertensive potential within 7 days prior to inclusion •Chronic use of concomitant medications (e.g., tricyclic antidepressants) that would affect assessment of the effectiveness of the study medication •Documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator •Patients with history of hypersensitivity to the study medication or its excipients •Rhinitis medicamentosa •pregnant or lactating women •patients with history of nose surgery, after the injury of the facial skelet, after actinotherapy of the facial region •patients with the history of endocrine disease •patients with the history of narrow angle glaucoma •patients with the history of nasal polyps •any other disease or condition which may interfere with study assessments as judged by the investigator •alcohol or drug abuse •patients taking part in any other clinical trial or having participated in a clinical trial within the previous 3 months •clinically significant renal/hepatic impairment or serious heartdisease and uncontrolled hypertension •patients with pheochromocytoma •patients presenting any malignant disease •patients likely not to comply with the study procedures or with difficulties to understand the study procedures as judged by the investigator
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy parameter will be the absolute change from baseline to Day 4 in patient self-rated TNSS. The TNSS is a score evaluating four factors: runny nose, sneezing, nasal itching and congestion. All symptoms are rated using four-point scale with following interpretation: 0 = absent symptoms (no sign/symptom evident) 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated) 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable) 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The baseline value for TNSS is defined as the last measurement taken prior to application of test/reference drug. Day 4 assessment of TNSS was defined as endpoint (LOCF imputation technique will be used on ITT set).
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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 | 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 | 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 | 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 | No |
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.8.3 |
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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |