Bronchial Asthma
Conditions
Interventions
Trade Name: Flixotide 50 micrograms Evohaler
Pharmaceutical Form: Pressurised inhalation, suspension
Pharmaceutical form of the placebo: Pressurised inhalation, solution
Route of administration of th
Sponsors
University of Dundee(Research & Innovation Services)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Mild to moderate atopic asthmatics with FEV1 = 60% on =1000ug BDP or equivalent with concomitant persistent allergic rhinitis (SPT +ve and PC20 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Severe asthmatics as defined by an FEV1= 60% or PEF variability > 30% or with continual daytime or nocturnal symptoms. 2. Nasal Polyposis grade 2/3, deviated nasal septum = 50% 3. The use of oral corticosteroids within the last 3 months. 4. Recent respiratory tract infection (2 months). 5. Significant concomitant respiratory disease such as COPD, CF, ABPA, Pulmonary fibrosis, bronchiectasis and active pulmonary tuberculosis. 6. Any other significant medical condition or investigation result which in the opinion of the investigator may jeopardise the safety of the participant or the conduct of the protocol. 7. Any significant abnormal laboratory result as deemed by the investigators 8. Pregnancy, planned pregnancy or lactation 9. Known or suspected contra-indication to any of the IMP’s 10. Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1.Does treatment of the nose with intranasal steroid make a difference to airway hyperresponsiveness (AHR) and lower airway inflammation in people with combined asthma & rhinitis? i.e. does the use of intranasal steroid provide a steroid sparing effect in terms of the dose of inhaled steroid for the lower airway?;Secondary Objective: ;Primary end point(s): 1.The primary outcome will be dose response between inhaled Fluticasone 100 µg and Fluticasone 500µg (both with intranasal placebo) vs inhaled Fluticasone 100µg and nasal Fluticasone 200ug on Methacholine bronchial hyperresponsiveness (as the PC20 threshold value ) | — |
Countries
United Kingdom
Outcome results
None listed