EFFICACY AND SAFETY STUDY OF THE ANTIHISTAMINE V0114CP 2.5MG IN THE TREATMENT OF PERENNIAL ALLERGIC RHINITIS. RANDOMISED, DOUBLE-BLIND, THREE ARM PARALLEL GROUP STUDY INCLUDING PLACEBO AND ACTIVE CONTROL ARM (LEVOCETIRIZINE 5 MG)
- Conditions
- The intended indication for the product under development is the treatment of perennial allergic rhinitis.
- Registration Number
- EUCTR2007-003572-19-CZ
- Lead Sponsor
- Pierre Fabre Médicament
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1080
Patients with all the following criteria will be eligible for enrolment:
- over 18 year-old male or female ambulatory patient,
- suffering from a perennial allergic rhinitis (dust mite, animal dander, cockroaches) defined by :
- a recorded medical history of perennial rhinitis with symptoms (sneezing and/or nasal itching and/or aqueous rhinorrhea and/or nasal blockade) for at least two years; if, for a new patient, the medical history has never been recorded, the clinical diagnosis will be assessed by the score for allergic rhinitis (SFAR),
NB: patients having episode(s) of symptomatic seasonal allergic rhinitis are eligible if the period 1 of the study (first 6 weeks) is performed out of the expected period(s) of the concerned seasonal allergens (e.g.: chestnut, grey alder, cypress, silver birch, mimosa, white ash, wall pellitory).
- a positive prick test and/or positive specific IgE (class ³3 or equivalent) to the concerned allergen(s) (dust mite, animal dander, cockroaches), duly documented in the medical file within the past 12 months,
- with an instantaneous morning nasal symptom score ³ 6 during at least 4 days during the 7 days before inclusion (maximal score: 12),
- in case of associated bronchial asthma, will be allowed only mild intermittent asthma, not requiring corticosteroids treatment,
- willing and able to understand and sign an approved Informed Consent Form,- able to understand the protocol and to attend the control visits,
- if required by national regulation, registered with a social security or health insurance system.
For women of child bearing potential:
- use of an contraceptive method (oral contraceptive, intra-uterine device, tubal ligature),
- negative urine pregnancy test.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Criteria related to pathologies
- Any cardio-vascular, renal, hepatic, gastro-intestinal, endocrine, haematological, neuro-psychiatric severe diseases that was not compatible with the participation to the study in the opinion of the investigator,
- Any acute or chronic disease that did not allow with the participation to the study in the opinion of the investigator,
- Chronic alcoholism,
- History of agranulocytosis,
- Congenital galactosemia, malabsorption syndrom to glucose or galactose, or lactase deficiency,
- Seizure,
- Severe nasal obtruction (score = 3),
- Iatrogenic rhinitis,
- Nasal polyposis or severe deviation of the nasal septum,
- History of nasal surgery,
- Acute or chronic rhinosinusitis, as defined by EP3OS guideline,
- Upper respiratory tract infection within the last 3 weeks.
Criteria related to treatments
- Medical history of hypersensitivity to mequitazine or drug excipients,
- Specific desensitization to perennial allergens finished within the last 6 months, whatever the issue,
- Depot corticosteroid treatment within the last 6 months,
- Oral, intramuscular or intravenous corticosteroid treatment within the last 8 weeks,
- Nasal or ocular corticosteroid treatment within the last 4 weeks,
- Inhaled corticosteroid treatment within the last 4 weeks,
- Potent and/or superpotent topical corticosteroid within the last 4 weeks,
- Treatment by antileukotriene within the 7 days,
- Treatment by cromone or ketotifen within the last 2 weeks,
- Treatment by antihistamine within the last 7 days, by loratadine within the last 10 days,
- Treatment by NSAIDs (other than oxicams) within the last 3 days,
- Treatment by oxicams within the last 7 days,
- Regular treatment by nasal or oral decongestive drug within the last 7 days,
- Treatment by tricyclic antidepressants (wash-out 4 weeks), MAO inhibitors (wash-out 4 weeks), atropine-like drugs (wash-out 4 weeks).
Criteria related to the population
- QTc interval > 450 ms,
- poor compliance for fulfilling the diary during the selection period, as judged by the investigator,
- participation to another clinical trial in the previous month or during the study,
- patient who, in the judgement of the investigator is not likely to be compliant during the study,
- patient who has forfeited his/her freedom by administrative or legal award, or who is under guardianship,
- subject who cannot be contacted in case of emergency.
For women of childbearing potential:
- pregnancy or breast feeding.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method