Asthma, Allergic Rhinitis
Conditions
Keywords
Asthma, Allergic rhinitis, fluticasone, methacholine
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.
Interventions
DRUGFluticasone Evohaler pMDI
One puff of inhaled Fluticasone Evohaler pMDI 50 µg twice a day (Total FP dose 100 µg)
DRUGPlacebo
1 puff of inhaled Placebo twice a day
DRUGFluticasone Evohaler
One puff of inhaled Fluticasone Evohaler 250µg twice a day (Total daily FP dose 500µg)
placebo intranasal spray 2 squirts each nostril once a day
DRUGfluticasone propionate (Flixonase®)
intranasal fluticasone propionate (Flixonase®) 50ug 2 squirts
Sponsors
University of Dundee
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| methacholine PC20 | 0, 2, 4, 6, 8, 10, 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Juniper AQLQ | 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 |
| blood eosinophils | 0, 2, 4, 6, 8, 10, 12 weeks |
| Spirometry | 0, 2, 4, 6, 8, 10, 12 weeks |
| Peak Nasal Inspiratory Flow rate | 0, 2, 4, 6, 8, 10, 12 weeks |
| Nasal Nitric Oxide | 0, 2, 4, 6, 8, 10, 12 weeks |
| Juniper mini RQLQ | 0, 2, 4, 6, 8, 10, 12 weeks |
| Overnight urinary cortisol creatinine | 0, 2, 4, 6, 8, 10, 12 weeks |
Countries
United Kingdom
Outcome results
None listed