Intranasal Fluticasone Propionate & Azelastine in Asthma & Rhinitis

Phase 1

• Conditions: Asthma and allergic rhinitis; MedDRA version: 20.0Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 100000004855; MedDRA version: 20.0Level: LLTClassification code 10001723Term: Allergic rhinitisSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-001093-17-GB
• Lead Sponsor: Tayside Medical Sciences Centre on behalf of University of Dundee & NHS Tayside

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-05
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

•Male or female volunteers aged 18 years and above with persistent asthma and allergic rhinitis
•On a minimum of 200µg BDP of 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
•Agreement for their GP to be made aware of study participation and to receive feedback as relevant to the participant’s well being

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

•Other respiratory diseases such as COPD, bronchiectasis or 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
•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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effects of using combined intranasal fluticasone propionate plus azelastine nasal spray on airway hyperresponsiveness in patients with persistent asthma and allergic rhinitis;Secondary Objective: To assess the effects of combined intranasal fluticasone propionate plus azelastine nasal spray on exhaled nitric oxide (FeNO), forced expiratory volume in 1 second (FEV1), morning peak expiratory flow (PEF), impulse oscillometry, peak nasal inspiratory flow (PNIF), nasal nitric oxide, blood eosinophils, eosinophil cationic protein (ECP), nasal symptoms, asthma control and quality of life; and rhinitis quality of life.;Primary end point(s): Methacholine PC20;Timepoint(s) of evaluation of this end point: 3 to 5 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): FeNO<br>FEV1 <br>Morning PEF<br>IOS indices (which includes R5, R20, R5-R20, AX, X5 and RF)<br>Domiciliary PNIF <br>Nasal NO<br>Blood eosinophils<br>ECP<br>TNS-4 <br>ACQ<br>AQLQ<br>RQLQ<br>VAS<br><br>;Timepoint(s) of evaluation of this end point: 3 to 5 weeks