Effects of Intranasal Fluticasone Plus Azelastine on Airway Inflammation in Patients With Asthma & Allergic Rhinitis

• Status: Terminated
• Trial end date: 2018-09-10
• Target enrollment: 0
• Participant gender: All

Summary

Single centre, double-blind, placebo controlled, adaptive design, cross-over trial. The primary objective is to assess the additive effects of using combined intranasal fluticasone propionate plus azelastine nasal spray on airway hyperresponsiveness. This is in patients with persistent asthma and allergic rhinitis, receiving inhaled steroid.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Dundee
• Treatments: Azelastine; Fluticasone

Criteria

Inclusion Criteria:

• Male or female volunteers, aged 18 years and above, with persistent asthma and allergic rhinitis

• On a minimum of 200μg BDP of Inhaled corticosteroid (ICS)

• FEV1 ≥ 60 % predicted

• Positive skin prick test, or record of elevated allergen-specific IgE to at least 1 perennial allergen

• Methacholine PC20 < 8mg/ml at Visit 1

• Ability to give informed consent

Exclusion Criteria:

• Other respiratory diseases such as COPD, bronchiectasis or allergic bronchopulmonary aspergillosis (ABPA) which are considered to be significant in the opinion of the study physician Nasal polyps ≥ Grade 2

• An asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month of the study commencement, or 3 months if hospital admission was required

• Any clinically significant medical condition that may endanger the health or safety of the participant. For example: Patients who have tuberculosis or any type of untreated infection or have had recent surgical operation or injury to the nose or mouth.

• Participation in another trial within 30 days before the commencement of the study

• Pregnancy or lactation

• Unable to comply with the procedures of the protocol

• Unable or unwilling to consent

• Taking prohibited medications as listed in section 6.7.2 Prohibited Medications

• Hypersensitivity to the active substances or to any of the excipients of Dymista Nasal Spray.