Steroid Sparing Effect of Nasal Corticosteroid In Asthma And Rhinitis

University of Dundee

Status and phase: Completed; Phase 4

Conditions: Asthma; Allergic Rhinitis

Treatments: Drug: Fluticasone Evohaler pMDI; Drug: Placebo; Drug: fluticasone propionate (Flixonase®); Drug: Placebo intranasal spray; Drug: Fluticasone Evohaler

Study type: Interventional

Funder types: Other

Identifiers

NCT00903227

2005-005557-22 (EudraCT Number)

NAI03

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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25 participants in 3 patient groups

Low Dose

Experimental group

Description:

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.

Treatment:

Drug: Fluticasone Evohaler pMDI

Drug: Placebo intranasal spray

Drug: Placebo

Combined

Experimental group

Description:

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).

Treatment:

Drug: Fluticasone Evohaler pMDI

Drug: Placebo

Drug: fluticasone propionate (Flixonase®)

High dose

Experimental group

Description:

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.

Treatment:

Drug: Fluticasone Evohaler

Drug: Placebo intranasal spray

Drug: Placebo