Steroid Sparing Effect of Nasal Corticosteroid In Asthma And Rhinitis

Phase 4

Completed

• Conditions: Asthma; Allergic Rhinitis
• Interventions: Drug: Fluticasone Evohaler pMDI; Drug: Fluticasone Evohaler; Drug: Placebo; Drug: Placebo intranasal spray; Drug: fluticasone propionate (Flixonase®)

• Registration Number: NCT00903227
• Lead Sponsor: University of Dundee

Brief Summary

Up to 40% of patients with asthma have allergic rhinitis and treatment of nasal airway inflammation with topical steroids improves the twitchiness of the airways (hyperresponsiveness) and overall asthma control. The use of inhaled corticosteroids reduces symptoms, severity of asthma attacks, improves quality of life, and reduces asthma related deaths. Similarly, treatment of rhinitis with nasal steroids reduces symptoms and improves quality of life. While there is evidence that combined treatment of the nose and the lungs with topical steroids improves symptoms and underlying inflammation, it is unclear whether such control can be achieved using a smaller dose of inhaled steroid in combination with nasal steroid. It is therefore the intention of this study to evaluate if combination steroid therapy (nose and lungs) has a steroid sparing effect in patients with asthma and rhinitis using sensitive markers of airway inflammation.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Study First Submitted: 2009-05-14
• Study First Submitted QC: 2009-05-14
• Study First Posted: 2009-05-18
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-10
• Last Update Posted: 2019-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Mild to moderate atopic asthmatics with FEV1 ≥ 60% on ≤ 1000 ug BDP and concomitant persistent allergic rhinitis (SPT +ve and PC20 < 4 mg/ml)
• Male or female aged 18-65 years
• Informed Consent
• Ability to comply with the requirements of the protocol

Exclusion Criteria

• Severe asthmatics as defined by an FEV1 ≤ 60% or PEF variability > 30% or with continual daytime or nocturnal symptoms.
• Nasal Polyposis grade 2/3, deviated nasal septum ≥ 50%
• The use of oral corticosteroids within the last 3 months
• Recent respiratory tract infection (2 months)
• Significant concomitant respiratory disease
• Any other significant medical condition or investigation which may jeopardise the safety of the participant or the conduct of the protocol
• Any significant abnormal laboratory result as deemed by the investigators
• Pregnancy, planned pregnancy or lactation
• Known or suspected contra-indication to any of the IMP's
• Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High dose	Fluticasone Evohaler	One puff of inhaled Fluticasone Evohaler 250µg twice a day (Total daily FP dose 500µg) and 1 puff of inhaled placebo twice a day with placebo intranasal spray 2 squirts each nostril once a day.
Combined	Fluticasone Evohaler pMDI	One puff of inhaled fluticasone propionate Evohaler pMDI 50 µg twice a day (Total daily FP dose 100 µg) and 1 puffs of Placebo twice a day with intranasal fluticasone propionate (Flixonase®) 50ug 2 squirts each nostril once a day (i.e. total intranasal FP daily dose 200ug).
Combined	Placebo	One puff of inhaled fluticasone propionate Evohaler pMDI 50 µg twice a day (Total daily FP dose 100 µg) and 1 puffs of Placebo twice a day with intranasal fluticasone propionate (Flixonase®) 50ug 2 squirts each nostril once a day (i.e. total intranasal FP daily dose 200ug).
Low Dose	Placebo	One puff of inhaled Fluticasone Evohaler pMDI 50 µg twice a day (Total FP dose 100 µg) and 1 puff of inhaled Placebo twice a day with placebo intranasal spray 2 squirts each nostril once a day.
Low Dose	Placebo intranasal spray	One puff of inhaled Fluticasone Evohaler pMDI 50 µg twice a day (Total FP dose 100 µg) and 1 puff of inhaled Placebo twice a day with placebo intranasal spray 2 squirts each nostril once a day.
Combined	fluticasone propionate (Flixonase®)	One puff of inhaled fluticasone propionate Evohaler pMDI 50 µg twice a day (Total daily FP dose 100 µg) and 1 puffs of Placebo twice a day with intranasal fluticasone propionate (Flixonase®) 50ug 2 squirts each nostril once a day (i.e. total intranasal FP daily dose 200ug).
Low Dose	Fluticasone Evohaler pMDI	One puff of inhaled Fluticasone Evohaler pMDI 50 µg twice a day (Total FP dose 100 µg) and 1 puff of inhaled Placebo twice a day with placebo intranasal spray 2 squirts each nostril once a day.
High dose	Placebo intranasal spray	One puff of inhaled Fluticasone Evohaler 250µg twice a day (Total daily FP dose 500µg) and 1 puff of inhaled placebo twice a day with placebo intranasal spray 2 squirts each nostril once a day.
High dose	Placebo	One puff of inhaled Fluticasone Evohaler 250µg twice a day (Total daily FP dose 500µg) and 1 puff of inhaled placebo twice a day with placebo intranasal spray 2 squirts each nostril once a day.

Primary Outcome Measures

Name	Time	Method
methacholine PC20	0, 2, 4, 6, 8, 10, 12 weeks

Secondary Outcome Measures

Name	Time	Method
Juniper AQLQ	0, 2, 4, 6, 8, 10, 12 weeks
blood eosinophils	0, 2, 4, 6, 8, 10, 12 weeks
Peak Nasal Inspiratory Flow rate	0, 2, 4, 6, 8, 10, 12 weeks
Fractionated Nitric Oxide	0, 2, 4, 6, 8, 10, 12 weeks
serum ECP	0, 2, 4, 6, 8, 10, 12 weeks
Overnight urinary cortisol creatinine	0, 2, 4, 6, 8, 10, 12 weeks
Nasal Nitric Oxide	0, 2, 4, 6, 8, 10, 12 weeks
Spirometry	0, 2, 4, 6, 8, 10, 12 weeks
Juniper mini RQLQ	0, 2, 4, 6, 8, 10, 12 weeks

Trial Locations

Locations (1)

Asthma and Allergy Research Group, Ninewells Hospital and University of Dundee; 🇬🇧 Dundee, Angus, United Kingdom