Study assessing safety and tolerability of a nasal spray combination of azelastine and fluticasone in patients with chronic rhinitis

• Conditions: treatment of chronic allergic or non-allergic rhinitis; MedDRA version: 13.1Level: LLTClassification code 10034382Term: Perennial allergic rhinitisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 13.1Level: LLTClassification code 10034383Term: Perennial rhinitisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2011-001368-23-Outside-EU/EEA
• Lead Sponsor: MedPointe Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Patients with established history (= 1 year) of rhinitis due to perennial allergies or non-allergic rhinitis (VMR)
• General good health and lack of any disease or concomitant treatment that could have interfered with the interpretation of the study results
Are the trial subjects under 18? yes
Number of subjects for this age range: 36
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 569
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

• Presence on nasal examination of any nasal ulceration (grade 3) or nasal septal perforation (grade 4) on screening visit or randomisation visit
• Nasal surgery or sinus surgery within the previous year
• Chronic sinusitis with more than 3 episodes per year
• Patients currently or during the previous 6-months on sublingual immunotherapy
• Patients with a fasting morning plasma cortisol level less than or equal to 5 µg/dL (or 150 nmol/L) for patients participating in the HPA axis sub-study
• Patients receiving immunotherapy injections and not on stable maintenance regimen for at least 30 days before the first study visit
• Use of systemic corticosteroid, omalizumab or inhaled corticosteroids / inhaled corticosteroid in combination 30 days prior to screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified