Allergic rhinitis
Conditions
Interventions
Product Name: Dymista
Pharmaceutical Form: Nasal spray
Pharmaceutical form of the placebo: Nasal spray
Route of administration of the placebo: Intranasal use (Noncurrent)
Sponsors
MEDA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with an ARIA-based diagnosis of persistent moderate/severe AR (= 2 nasal symptoms suggestive of allergic rhinitis and positive skin prick tests to HDM (HAL Allergy, Leiden, The Netherlands) at screening. Patients with additional seasonal pollen allergies may be included providing that they are included outside their individual pollen season, and with VAS score for total nasal symptoms of more than 5 2. VAS for TNS of more than 5, and rT5SS of more than 8 at both screening and randomization 3. Age > 18 and 20 %) at randomization 6. Possibility to give reliable information and written informed consent 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 45 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any evidence of clinically relevant acute or chronic cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, mental, neurological, or other disease at screening 2. History of allergic reaction to fluticasone propionate, azelastine hydrochloride or one of the excipients (e.g. benzalkonium chloride, phenylethyl alcohol, microcrystalline cellulose) 3. Patients with a change in vision or with a history of increased ocular pressure, glaucoma and/or cataracts 4. Patients with tuberculosis, any type of untreated infection, or recent surgical operation or injury to the nose or mouth 5. Patients with moderate persistent to severe persistent asthma according to GINA criteria (9) 6. Patients on prolonged use of decongestive nose sprays, suffering from so-called rhinitis medicamentosa 7. Patients using other nasal or oral medication affecting nasal function, like nasal corticosteroids, anticholinergics, cromoglycates, leukotriene antagonists, ACE inhibitors during the study or within the last 14 days before randomization; patients using oral corticosteroids during the last 30 days 8. Patients using cytochrome P450 3A4 inhibitors (e.g. ritonavir) 9. Nasal endoscopic evidence of rhinosinusitis w/wo NP or structural abnormalities such as clinically relevant septal deviation (septum reaching concha inferior or lateral nasal wall) or septal perforation at screening 10. Patients on immunotherapy (IT) for HDM or with history of IT for HDM 11. Patients with a psychiatric, addictive, or any disorder of which the investigators feel that this may compromise the ability to give truly informed consent for participation in this study or provide reliable information on the questionnaire 12. Patients being enrolled in other clinical trials within the last 3 months 13. Pregnancy or breastfeeding 14. Malignancies or severe comorbidity 15. Smoking 16. Use of anticoagulation medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the effects of 4 weeks of MP 29-02 on inflammatory mediators in allergic rhinitis;Secondary Objective: The secondary objectives of the study are to evaluate the effects of 1 week and 4 weeks of therapy with MP 29-02 or placebo on nasal hyperreactivity; the effects of therapy on nasal inflammatory mediators after 1 week of therapy and the effects of therapy on the patient reported symptoms. ;Primary end point(s): Evaluation of the effects of 4 weeks of therapy with MP 29-02 or placebo nasal spray on nasal inflammatory mediators (histamine, substance P (SP), IL-5 and eosinophil peroxidase (EPO)). Nasal fluid will be collected by means of merocells and the above mentioned mediators will be measured by means of ELISA. ;Timepoint(s) of evaluation of this end point: 4 weeks after start of the therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Effects of nasal MP 29-02 or placebo on nasal hyperreactivity after 1 week and after 4 weeks. This will be measured by means of a Cold Dry Air provocation with assessment of the Peak Nasal Inspiratory Flow before and after the provocation. - Measurement of mediators in nasal fluid after 1 w of therapy. - Effects of 1 and 4 weeks of nasal therapy with MP 29-02 or placebo on patient reported symptoms by means of questionnaires (Visual Analogue Scale, Total Nasal Symptom Scores and the Allergic Rhinitis Control Test) ;Timepoint(s) of evaluation of this end point: 1 week and 4 weeks after start of the therapy | — |
Countries
Belgium
Contacts
Public ContactIngrid Schwienhorst
MEDA
Outcome results
None listed