Allergic Rhinitis
Conditions
Interventions
Trade Name: Flixotide 250 micrograms Evohaler
Product Name: Flixotide 250 micrograms Evohaler
Pharmaceutical Form: Pressurised inhalation, suspension
Pharmaceutical form of the placebo: Pressurised i
Sponsors
University of Dundee (Research & Innovation Services)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Persistent allergic rhinitis without asthma. 2. Atopy to at least 1 allergen on SPT. 3. = 20% drop in PNIF following nasal AMP challenge 4. Male to female aged 18-65 5. Informed Consent 6. Ability to comply with the protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Severe allergic rhinitis as defined by those in whom there are symptoms which significantly impair day to day activities on QOL questionnaire. 2. Nasal Polyposis grade 2/3, deviated nasal septum = 50% 3. PNIF < 60 litres/min 4. The use of oral corticosteroids within the last 3 months. 5. Recent respiratory tract / sinus infection (2 months). 6. Significant concomitant respiratory disease such as COPD, CF, ABPA, bronchiectasis and active pulmonary tuberculosis. 7. Any other clinically significant medical condition such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA/ CVA,that may endanger the health or safety of the participant, or jeopardise the protocol. 8. Any significant abnormal laboratory result as deemed by the investigators 9. Pregnancy, planned pregnancy or lactation 10. Known or suspected contra-indication to any of the IMP’s 11. 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. To evaluate effect of Long acting beta agonist (LABA) & Intra nasal Corticosteroid (INCS) alone and in combination on the anti-inflammatory response to nasal Adenosine Monophosphate(AMP) challenge ;Secondary Objective: ;Primary end point(s): 1.The primary endpoint will be the % maximum fall in Peak Nasal Inspiratory Flow following nasal AMP challenge post LABA, INCS, and combined LABA + INCS , when compared to placebo. | — |
Countries
United Kingdom
Outcome results
None listed