A proof of concept study to evaluate if concomitant topical intranasal steroid prevents tolerance and rebound congestion due to regular oxymetazoline in persistent allergic rhinitis - Preventing tolerance to oxymetazoline in allergic rhinitis

• Conditions: Allergic Rhinitis; MedDRA version: 9.1Level: LLTClassification code 10001723Term: Allergic rhinitis; MedDRA version: 9.1Level: LLTClassification code 10039090Term: Rhinitis medicamentosa

• Registration Number: EUCTR2007-003291-19-GB
• Lead Sponsor: niversity of Dundee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 < 120 L/min (best of 3) and reversibility with Oxymetazoline 2 squirts in each nostril (20 min reading) >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
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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