treatment of chronic allergic or non-allergic rhinitis MedDRA version: 13.1 Level: LLT Classification code 10034382 Term: Perennial allergic rhinitis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 13.1 Level: LLT Classification code 10034383 Term: Perennial rhinitis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Fixed combination AZE-FLU nasal spray
Product Code: MP29-02
Pharmaceutical Form: Nasal spray, suspension
INN or Proposed INN: azelastine hydrochloride
CAS Number: 79307-93-0
Other descri
Sponsors
MedPointe Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of azelastine hydrochloride and fluticasone propionate combination nasal spray in chronic use daily over a 1-year period ;Secondary Objective: not applicable;Primary end point(s): • Frequency of patient-reported adverse events • Evaluation of the cumulative effect of AZE-FLU by nasal examination • Eye examination by an ophthalmologist;Timepoint(s) of evaluation of this end point: • Adverse events upon occurrence • Cumulative effect of AZE-FLU by nasal examination: screening visit, randomisation visit, and visits on days 30, 90, 180, 270, and 365, if applicable • Eye examination by an ophthalmologist: screening visit and visits on days 180 and 365, if applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Adherence to therapy • Efficacy as assessed by Total Nasal Symptom Score (TNSS) • Fasting plasma cortisol levels (at selected study sites);Timepoint(s) of evaluation of this end point: • Adherence to therapy: each study visit • Efficacy as assessed by Total Nasal Symptom Score (TNSS): Nasal symptom scores for rhinorrhea, sneezing, itchy nose, and nasal congestion (the sum of which comprised the TNSS) were recorded twice daily (AM and PM) during the screening period. After randomization, scores were recorded once daily, in the evening (PM), as an evaluation of symptom severity over the previous 12 hours (12-hour reflective TNSS). This score was recorded once daily prior to the PM dose for MP29-02 subjects and once daily approximately 12 hours after the AM dose for the fluticasone propionate subjects for each day of the study. • Fasting plasma cortisol levels (at selected study sites): screening visit and visits on days 180 and 365, if applicable | — |
Countries
India
Contacts
Public ContactDepartment Clinical Development
MEDA Pharma GmbH & Co. KG
Outcome results
None listed