Allergic Rhinitis MedDRA version: 9.1 Level: LLT Classification code 10001723 Term: Allergic rhinitis MedDRA version: 9.1 Level: LLT Classification code 10039090 Term: Rhinitis medicamentosa
Conditions
Interventions
Product Name: Oxymetazoline hydrochloride/Fluticasone propionate
Product Code: OXY-FP
Pharmaceutical Form: Nasal spray*
INN or Proposed INN: Oxymetazoline hydrochoride
CAS Number: 1491-59-4
Concentrat
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Male of Female aged 18-75 years. 2. Persistent allergic rhinitis with or without asthma. 3. Atopy to atleast one allergen on Skin Prick Testing. 4. PNIF 20L/min. 5. Ability to give a written informed consent. 6. Ability and willingness to comply with the requirements of 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: Exclusion criteria 1. Nasal Polyposis grade 2+[28], Deviated nasal septum = 50% (50% reduction in expected cavity cross-sectional area). 2. The use of oral corticosteroids within the last 3 months. 3. Recent respiratory tract/sinus infection within the last 2 months. 4. Uncontrolled Hypertension. 5. Any clinically significant medical condition such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA/CVA, that may endanger the health and safety of the participant, or jeopardise the protocol. 6. Pregnancy, planned pregnancy or lactation. 7. Any significant abnormal laboratory result as deemed by the investigators. 8. Known or suspected hypersensitivity to any of the IMP’s. 9. Concomitant use of medicines (prescribed, OTC or herbal) like alpha blockers that may interfere with the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the duration of onset of rebound nasal congestion and tolerance to regular oxymetazoline nasal spray in Persistent Allergic Rhinitis and evaluate the effect of Fluticasone on prevention of Rhinitis Medicamentosa;Secondary Objective: ;Primary end point(s): The primary endpoint will be the difference in domiciliary PNIF improvement between two groups | — |
Countries
United Kingdom
Outcome results
None listed