Clinical Trials Logo
  1. Home
  2. Allergic Rhinitis
  3. NCT01190852

Single Dose Pharmacokinetics of Intranasal Azelastine Delivered by a Fixed Combination With Fluticasone in Comparison to Azelastine Nasal Sprays

Allergic Rhinitis Clinical Trial

Official title:
Single Dose Pharmacokinetics of Intranasal Azelastine Delivered by a Fixed Combination With Fluticasone in Comparison to Azelastine Nasal Sprays Single-centre, Randomised, Open-label, Three-period, Six-sequence Cross-over Trial (William's Design)

Clinical Trial Summary

The primary objective is to assess the effect of fluticasone propionate (FLU) on the relative bioavailability (AUC0-∞) of azelastine hydrochloride (AZE) when administered as fixed AZE-FLU combination product (TEST) compared to a similar formulation without containing FLU (i.e. AZE alone; REF). The secondary objectives are to compare the relative bioavailability (AUC0-∞) of AZE when administered either as fixed AZE-FLU combination product (TEST) or as marketed AZE product Astelin® Nasal Spray (COMP); To compare the effects of FLU on other pharmacokinetic parameters of AZE (AUC0-tlast, CL/f, Cmax, tmax, t½); To assess adverse events.

Clinical Trial Description

This study will enrol healthy subjects. It is considered that study results are more discriminative in healthy subjects than in rhinitis patients as there are no interferences by varying rhinitis symptoms and respective differences in the status of the nasal mucosa regarding the 3 study periods. The time schedule for plasma sampling (pre-dose and 15, 30 min, 1, 1½, 2, 2½, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 h p.a.; time refer to the end of the second spray into the second nostril of each administration) is derived from previous bioavailability study on the marketed product Astelin® Nasal Spray assuming a mean tmax of 2 to 3 h p.a. and a mean t1/2 of 22 h [L7]. Sampling times are expected to cover an AUC0-tlast above 80% of the total AUC of azelastine hydrochloride (bioanalytical detection method with a LLOQ of 2 pg/mL). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01190852
Study type Interventional
Source Viatris Inc.
Contact
Status Completed
Phase Phase 1
Start date August 2010
Completion date October 2010
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05080322 - Efficacy and Safety of On-demand and Continuous Administration of Nasal Spray in the Treatment of Allergic Rhinitis Phase 4
Recruiting NCT06028490 - A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis. Phase 2
Completed NCT04388358 - Traditional Chinese Medicine for the Treatment of Perennial Allergic Rhinitis on Gut Microbiota and Immune-modulation N/A
Recruiting NCT04202263 - Assessment of Suppression of Cutaneous Allergic Responses and Pruritis by Topical Minocycline Phase 2
Completed NCT04078009 - Standardising Nasal Allergen Challenge in Adult With Hay Fever N/A
Completed NCT03644680 - Changes in Adaptive Immune Responses and Effector Cell Responses Upon Nasal Allergen Exposure - a Pilot Study N/A
Completed NCT04541004 - Adolescent Mite Allergy Safety Evaluation Phase 3
Recruiting NCT05378594 - HDM and Silver Birch NAC Standardisation N/A
Not yet recruiting NCT05684380 - Efficacy and Safety of MAZ-101 in the Treatment of Persistent Allergic Rhinitis (PER) Phase 3
Completed NCT02910401 - Clinical Response to Rhinovirus Challenge Phase 2
Completed NCT02943720 - ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen Phase 2
Not yet recruiting NCT01014325 - Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy Phase 3
Completed NCT02556801 - Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy Phase 2
Completed NCT02352168 - Airway Inflammation in Children With Allergic Rhinitis and Intervention N/A
Not yet recruiting NCT02233426 - Effect of Hypertonic Solutions on Allergic Rhinitis Patients N/A
Completed NCT01918956 - PURETHAL Birch RUSH Study Phase 4
Completed NCT01946035 - Alpha-Blockers in Allergic Rhinitis (MAN 01) Phase 4
Completed NCT01682070 - SUBLIVAC FIX Phleum Pratense DT/DRF Phase 2
Recruiting NCT01454492 - The Relationship Between Allergic Rhinitis and Geographic Tongue N/A
Completed NCT01439815 - An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo Phase 4